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Ewoud Schuit - One of the best experts on this subject based on the ideXlab platform.

  • child outcomes after placement of a cervical Pessary in women with a multiple pregnancy a 4 year follow up of the protwin trial
    Acta Obstetricia et Gynecologica Scandinavica, 2019
    Co-Authors: Noor E Simons, Sophie Liem, Ewoud Schuit, Brent C Opmeer, Leonie J P Steenis, Cornelieke Van De Beek, Johanna H Van Der Lee, Aleid G Van Wassenaerleemhuis, Anneloes L Van Baar, Dick J Bekedam
    Abstract:

    Introduction: The ProTWIN trial previously showed no beneficial effect of treatment with a cervical Pessary vs usual care to prevent preterm birth in women with a multiple pregnancy. However, in women with a midtrimester short cervix (<38 mm), Pessary did reduce the composite outcome of neonatal morbidity and mortality. This follow-up study evaluates the long-term outcomes of all children born to mothers who participated in the ProTWIN trial at 4 years of age. Material and methods: Parents received the Ages and Stages Questionnaire, Strength and Difficulties Questionnaire and a health questionnaire. All questionnaires were reported separately and as a combined outcome (abnormal child outcome). A linear mixed effects model was used to adjust for correlated data in twins and correction for confounders was performed. In exploratory analysis, a composite outcome of death or survival with abnormal child outcome was used by combining extrapolated data on child outcome with survival data. All data were analyzed for the total group and the subgroup of women with midtrimester short cervix. Results: Of the original 813 women of the ProTWIN trial, we approached 579, of whom 258 participated (45%) in follow up. We received questionnaires of 514 children (281 Pessary vs 233 control), with 119 children in the subgroup of women with midtrimester short cervix. An abnormal child outcome was found in 23% in the Pessary group vs 16% in the control group (odds ratio 1.58; 95% confidence interval.94-2.65). In exploratory analysis with extrapolated data on child outcome (n = 815), no difference in abnormal child outcome was seen between the Pessary and control group. In the subgroup of women with a short cervix (n = 268), this composite outcome indicated a favorable outcome for children born to mothers with Pessary. Conclusions: In women with a multiple pregnancy, the use of a cervical Pessary did not improve development, behavior or physical outcomes of the surviving children at age 4.

  • cervical Pessary after arrested preterm labor a randomized controlled trial
    Obstetrics & Gynecology, 2018
    Co-Authors: Frederik J R Hermans, Ewoud Schuit, Maureen T M Franssen, Hubertina C J Scheepers, Mireille N Bekker, Mallory Woiski, Marjon A De Boer, Marieke Sueters, Eva Pajkrt, Ben W J Mol
    Abstract:

    OBJECTIVE: To assess the effectiveness of cervical Pessary in reducing the rate of preterm birth in women at high risk for preterm birth who did not deliver after an episode of threatened preterm labor. METHODS: In a multicenter open-label randomized controlled trial, a cervical Pessary was compared with no intervention (control group) (one-to-one ratio). Women between 24 and 34 weeks of gestation at high risk for preterm birth based on a short cervical length (less than 15 mm) or an intermediate cervical length (between 15 and 30 mm) with a positive fetal fibronectin test who did not deliver after an episode of threatened preterm labor were eligible. The primary outcome was birth before 37 weeks of gestation. Secondary outcomes were a composite adverse neonatal outcome, preterm birth before 34 and 32 weeks of gestation, and side effects. A total sample size of 200 women carrying singletons was planned so as to have adequate statistical power to detect a reduction in the rate of preterm birth from 40% to 20%. Women with twin gestations were also enrolled but were considered only in secondary analyses. After a planned interim analysis, the trial was stopped for futility. RESULTS: From November 2013 through September 2016, 130 women with a singleton pregnancy (65 Pessary, 65 no treatment) were recruited. The groups had comparable baseline characteristics. In the cervical Pessary group, 31 (48%) women delivered before 37 weeks of gestation compared with 25 (39%) in the no-treatment group (relative risk 1.2, 95% CI 0.83-1.8). Nine (15%) children in the cervical Pessary group had the composite adverse perinatal outcome compared with eight (13%) in the control group (relative risk 1.2, 95% CI 0.49-2.9). CONCLUSION: In women at high risk for preterm birth who did not deliver after an episode of threatened preterm labor, treatment with a cervical Pessary is not effective.

  • Pessary for prevention of preterm birth in twin pregnancy with short cervix 3 year follow up study
    Ultrasound in Obstetrics & Gynecology, 2018
    Co-Authors: J Van T Hooft, Ewoud Schuit, Dick J Bekedam, Brent C Opmeer, J H Van Der Lee, A G Van Wassenaerleemhuis, A L Van Baar, Leonie J P Steenis, S M S Liem, Cuny Cuijpers
    Abstract:

    Objective A recent randomized clinical trial (ProTWIN) showed that a cervical Pessary prevented preterm birth and improved neonatal outcome in women with multiple pregnancy and cervical length (CL) < 38 mm. In this follow‐up study, the long‐term developmental outcome of these children was evaluated at 3 years' corrected age. Methods This was a follow‐up study of ProTWIN, a multicenter trial conducted between 2009 and 2012 in which asymptomatic women with a multiple pregnancy were randomized to placement of a cervical Pessary or no intervention. Current follow‐up and analysis were limited to mothers with a mid‐trimester CL < 38 mm (78 women (157 children) in the Pessary group and 55 women (111 children) in the control group). At 3 years of corrected age, surviving children were invited for a Bayley Scales of Infant and Toddler Development‐third edition (Bayley‐III) assessment. Death after randomization or neurodevelopmental disability (Bayley‐III score of ≤ 85, 1 SD below mean) rates were compared between the Pessary and control groups, according to the intention‐to‐treat principle and using multiple imputation for missing data. Mean Bayley‐III scores in surviving children were also assessed. A linear mixed‐effects model was used to adjust for correlation between children of one mother. Results From the time of entry in the ProTWIN trial until follow‐up at 3 years of age, a total of 27 children had died (six (5%) in the Pessary vs 21 (26%) in the control group; odds ratio (OR), 0.13; 95% CI, 0.04–0.48). Bayley‐III outcomes were collected for 173/241 (72%) surviving children (114 (75%) in the Pessary vs 59 (66%) in the control group). The cumulative incidence of death or survival with a neurodevelopmental disability was 12 (10%) in the Pessary vs 23 (29%) in the control group (OR, 0.26; 95% CI, 0.09–0.73). No statistical or clinically relevant differences were found with respect to cognitive, language and motor development among surviving children between the groups. Comparable results were found after multiple imputation. Conclusion In women with twin pregnancy and a CL < 38 mm, the use of a cervical Pessary strongly improved survival of the children without affecting neurodevelopment at 3 years' corrected age. Copyright © 2018 ISUOG. Published by John Wiley & Sons Ltd.

  • cervical pessaries to prevent preterm birth in women with a multiple pregnancy a per protocol analysis of a randomized clinical trial
    Acta Obstetricia et Gynecologica Scandinavica, 2016
    Co-Authors: Sophie Liem, Ewoud Schuit, Marielle G Van Pampus, Marjo J G J Van Melick, Maurice J M Monfrance, Josje Langenveld, Ben Willem J Mol, Dick J Bekedam
    Abstract:

    Introduction We recently showed that a cervical Pessary prevents preterm birth and reduces poor neonatal outcomes in women with a twin pregnancy and a short cervix (<38 mm). The objective of this study was to evaluate the full potential treatment effect of the Pessary in the whole group and in women with a short cervix. Material and methods We performed a per-protocol analysis of a multicenter randomized controlled trial (ProTWIN trial, NTR1858) where we excluded women who were allocated to the Pessary but never had it placed. Women who had the Pessary removed before 36 gestational weeks and did not deliver within 7 days after removal, were excluded. Analyses were performed on all women and in those with a cervical length <38 mm. Results In 23 (6%) women the Pessary was not placed. In women with a cervical length <38 mm (25th percentile) the Pessary reduced poor perinatal outcome (relative risk 0.32, 95% confidence interval 0.13–0.78) and birth at <32 weeks (relative risk 0.41, 95% confidence interval 0.20–0.87). After excluding 47 (12%) women, the time to delivery was longer in the Pessary group than in the control group (whole group: hazard ratio 0.68, 95% confidence interval 0.55–0.82, cervical length <38 mm: hazard ratio 0.35, 95% confidence interval 0.22–0.57). Conclusions The analysis confirms the principal findings of the intention-to-treat analysis. Time to delivery was longer in the Pessary group than in the control group when censored data were used. This implies the Pessary should not be removed until labor is evident.

  • cervical pessaries for prevention of preterm birth in women with a multiple pregnancy protwin a multicentre open label randomised controlled trial
    Obstetrical & Gynecological Survey, 2014
    Co-Authors: Sophie Liem, Ewoud Schuit, Maud A Hegeman, Joke M J Bais, Karin De Boer, Kitty W M Bloemenkamp, Jozien T J Brons, Hans Duvekot, Bas Nij Bijvank, Maureen T M Franssen
    Abstract:

    Women with multiple gestations often deliver at less than 37 weeks, increasing the risks of perinatal morbidity and mortality. Treatment with a Pessary might prevent preterm birth by changing the inclination of the cervical canal and preventing premature dilatation of the cervix, rupture of the membranes, and deterioration or loss of the cervical mucous plug. This multicenter, open-label, randomized controlled trial at 40 hospitals was performed to determine whether a cervical Pessary could prevent poor perinatal outcomes in parturients with a multiple pregnancy. At 12 to 20 weeks' gestation, patients were assigned to the Pessary or control group; cervical length was measured at 16 to 22 weeks. Women in the study group received an Arabin Pessary at 16 to 20 weeks, which was removed in week 36 or in case of preterm premature rupture of the membranes, active vaginal bleeding, other signs of preterm labor, or patient discomfort. Obstetric care was otherwise similar in the 2 groups. The primary outcome was a composite of poor perinatal outcomes, including stillbirth, preventricular leukomalacia, severe respiratory distress syndrome, bronchopulmonary dysplasia, intraventricular hemorrhage, necrotizing enterocolitis, sepsis, and neonatal death within 6 weeks after the anticipated term date. Secondary outcomes were time to delivery, preterm birth at less than 32 and less than 37 weeks, days in the neonatal intensive care unit, days of maternal admission for preterm labor, and maternal morbidity. A total of 401 of 403 women in the Pessary group and 407 of 410 in the control group completed the study. Five women in the Pessary group had a surgical cerclage; 1 patient died, and the others delivered at 21.6 to 36.7 weeks, with 3 having poor perinatal outcomes. No patients in the control group had a cerclage. Vaginal discharge occurred in 104 women (26%) in the Pessary group and in none of the controls. The Pessary was removed from 57 women (14%) at less than 28 weeks and from 22 women (5%) at 28 to 32 weeks; 7 and 13, respectively, delivered within 48 hours of removal. At 32 to 36 weeks, the Pessary was removed from 107 women; 70 delivered within 48 hours. The most common reasons for Pessary removal in these women were preterm premature rupture of the membranes, vaginal bleeding, contractions, and induction of labor. The composite poor perinatal outcome occurred in 53 women (13%) and 55 women (14%) in the Pessary and control groups, respectively (relative risk (RR), 0.98; 95% confidence interval, 0.69-1.39). Ten stillbirths (2%) occurred in each group. The other conditions within the composite outcome did not differ between the 2 groups. In the Pessary and control groups, 16 and 18 infants, respectively, died before discharge. The groups were similar in median gestational age at delivery; frequencies of delivery at less than 28, less than 32, and less than 37 weeks; and frequency and length of neonatal intensive care unit admission. In the women with a cervical length of less than 25th percentile ( <38 mm), the Pessary significantly reduced the frequency of poor perinatal outcomes and very preterm delivery. A cervical Pessary does not necessarily prevent poor perinatal outcomes or preterm birth in all women with a multiple gestation. Although the Pessary had a positive effect in women with a twin pregnancy and a short cervix, these results should be confirmed in additional prospective studies. The safety and low cost of the Pessary should be considered when counseling a parturient with a multiple pregnancy and short cervix

Sophie Liem - One of the best experts on this subject based on the ideXlab platform.

  • child outcomes after placement of a cervical Pessary in women with a multiple pregnancy a 4 year follow up of the protwin trial
    Acta Obstetricia et Gynecologica Scandinavica, 2019
    Co-Authors: Noor E Simons, Sophie Liem, Ewoud Schuit, Brent C Opmeer, Leonie J P Steenis, Cornelieke Van De Beek, Johanna H Van Der Lee, Aleid G Van Wassenaerleemhuis, Anneloes L Van Baar, Dick J Bekedam
    Abstract:

    Introduction: The ProTWIN trial previously showed no beneficial effect of treatment with a cervical Pessary vs usual care to prevent preterm birth in women with a multiple pregnancy. However, in women with a midtrimester short cervix (<38 mm), Pessary did reduce the composite outcome of neonatal morbidity and mortality. This follow-up study evaluates the long-term outcomes of all children born to mothers who participated in the ProTWIN trial at 4 years of age. Material and methods: Parents received the Ages and Stages Questionnaire, Strength and Difficulties Questionnaire and a health questionnaire. All questionnaires were reported separately and as a combined outcome (abnormal child outcome). A linear mixed effects model was used to adjust for correlated data in twins and correction for confounders was performed. In exploratory analysis, a composite outcome of death or survival with abnormal child outcome was used by combining extrapolated data on child outcome with survival data. All data were analyzed for the total group and the subgroup of women with midtrimester short cervix. Results: Of the original 813 women of the ProTWIN trial, we approached 579, of whom 258 participated (45%) in follow up. We received questionnaires of 514 children (281 Pessary vs 233 control), with 119 children in the subgroup of women with midtrimester short cervix. An abnormal child outcome was found in 23% in the Pessary group vs 16% in the control group (odds ratio 1.58; 95% confidence interval.94-2.65). In exploratory analysis with extrapolated data on child outcome (n = 815), no difference in abnormal child outcome was seen between the Pessary and control group. In the subgroup of women with a short cervix (n = 268), this composite outcome indicated a favorable outcome for children born to mothers with Pessary. Conclusions: In women with a multiple pregnancy, the use of a cervical Pessary did not improve development, behavior or physical outcomes of the surviving children at age 4.

  • cervical pessaries to prevent preterm birth in women with a multiple pregnancy a per protocol analysis of a randomized clinical trial
    Acta Obstetricia et Gynecologica Scandinavica, 2016
    Co-Authors: Sophie Liem, Ewoud Schuit, Marielle G Van Pampus, Marjo J G J Van Melick, Maurice J M Monfrance, Josje Langenveld, Ben Willem J Mol, Dick J Bekedam
    Abstract:

    Introduction We recently showed that a cervical Pessary prevents preterm birth and reduces poor neonatal outcomes in women with a twin pregnancy and a short cervix (<38 mm). The objective of this study was to evaluate the full potential treatment effect of the Pessary in the whole group and in women with a short cervix. Material and methods We performed a per-protocol analysis of a multicenter randomized controlled trial (ProTWIN trial, NTR1858) where we excluded women who were allocated to the Pessary but never had it placed. Women who had the Pessary removed before 36 gestational weeks and did not deliver within 7 days after removal, were excluded. Analyses were performed on all women and in those with a cervical length <38 mm. Results In 23 (6%) women the Pessary was not placed. In women with a cervical length <38 mm (25th percentile) the Pessary reduced poor perinatal outcome (relative risk 0.32, 95% confidence interval 0.13–0.78) and birth at <32 weeks (relative risk 0.41, 95% confidence interval 0.20–0.87). After excluding 47 (12%) women, the time to delivery was longer in the Pessary group than in the control group (whole group: hazard ratio 0.68, 95% confidence interval 0.55–0.82, cervical length <38 mm: hazard ratio 0.35, 95% confidence interval 0.22–0.57). Conclusions The analysis confirms the principal findings of the intention-to-treat analysis. Time to delivery was longer in the Pessary group than in the control group when censored data were used. This implies the Pessary should not be removed until labor is evident.

  • economic analysis of use of Pessary to prevent preterm birth in women with multiple pregnancy protwin trial
    Ultrasound in Obstetrics & Gynecology, 2014
    Co-Authors: Sophie Liem, Josje Langenveld, G J Van Baaren, Friso M C Delemarre, Inge M Evers, Gunilla Kleiverda, A J Van Loon, Nico W E Schuitemaker, J Sikkema, Brent C Opmeer
    Abstract:

    Objective To assess the cost-effectiveness of a cervical Pessary to prevent preterm delivery in women with a multiple pregnancy. Methods The study design comprised an economic analysis of data from a randomized clinical trial evaluating cervical pessaries (ProTWIN). Women with a multiple pregnancy were included and an economic evaluation was performed from a societal perspective. Costs were estimated between the time of randomization and 6 weeks postpartum. The prespecified subgroup of women with a cervical length (CL) < 25th centile (< 38 mm) was analyzed separately. The primary endpoint was poor perinatal outcome occurring up to 6 weeks postpartum. Direct medical costs and health outcomes were estimated and incremental cost-effectiveness ratios for costs to prevent one poor outcome were calculated. Results Mean costs in the Pessary group (n = 401) were €21 783 vs €21 877 in the group in which no Pessary was used (n = 407) (difference, −€94; 95% CI, −€5975 to €5609). In the prespecified subgroup of women with a CL < 38 mm we demonstrated a significant reduction in poor perinatal outcome (12% vs 29%; RR, 0.40; 95% CI, 0.19–0.83). Mean costs in the Pessary group (n = 78) were €25 141 vs €30 577 in the no-Pessary group (n = 55) (difference, −€5436 (95% CI, −€11 001 to €1456). In women with a CL < 38 mm, Pessary treatment was the dominant strategy (more effective and less costly) with a probability of 94%. Conclusion Cervical pessaries in women with a multiple pregnancy involve costs comparable to those in women without Pessary treatment. However, in women with a CL < 38 mm, treatment with a cervical Pessary appears to be highly cost-effective. Copyright © 2014 ISUOG. Published by John Wiley & Sons Ltd

  • cervical pessaries for prevention of preterm birth in women with a multiple pregnancy protwin a multicentre open label randomised controlled trial
    Obstetrical & Gynecological Survey, 2014
    Co-Authors: Sophie Liem, Ewoud Schuit, Maud A Hegeman, Joke M J Bais, Karin De Boer, Kitty W M Bloemenkamp, Jozien T J Brons, Hans Duvekot, Bas Nij Bijvank, Maureen T M Franssen
    Abstract:

    Women with multiple gestations often deliver at less than 37 weeks, increasing the risks of perinatal morbidity and mortality. Treatment with a Pessary might prevent preterm birth by changing the inclination of the cervical canal and preventing premature dilatation of the cervix, rupture of the membranes, and deterioration or loss of the cervical mucous plug. This multicenter, open-label, randomized controlled trial at 40 hospitals was performed to determine whether a cervical Pessary could prevent poor perinatal outcomes in parturients with a multiple pregnancy. At 12 to 20 weeks' gestation, patients were assigned to the Pessary or control group; cervical length was measured at 16 to 22 weeks. Women in the study group received an Arabin Pessary at 16 to 20 weeks, which was removed in week 36 or in case of preterm premature rupture of the membranes, active vaginal bleeding, other signs of preterm labor, or patient discomfort. Obstetric care was otherwise similar in the 2 groups. The primary outcome was a composite of poor perinatal outcomes, including stillbirth, preventricular leukomalacia, severe respiratory distress syndrome, bronchopulmonary dysplasia, intraventricular hemorrhage, necrotizing enterocolitis, sepsis, and neonatal death within 6 weeks after the anticipated term date. Secondary outcomes were time to delivery, preterm birth at less than 32 and less than 37 weeks, days in the neonatal intensive care unit, days of maternal admission for preterm labor, and maternal morbidity. A total of 401 of 403 women in the Pessary group and 407 of 410 in the control group completed the study. Five women in the Pessary group had a surgical cerclage; 1 patient died, and the others delivered at 21.6 to 36.7 weeks, with 3 having poor perinatal outcomes. No patients in the control group had a cerclage. Vaginal discharge occurred in 104 women (26%) in the Pessary group and in none of the controls. The Pessary was removed from 57 women (14%) at less than 28 weeks and from 22 women (5%) at 28 to 32 weeks; 7 and 13, respectively, delivered within 48 hours of removal. At 32 to 36 weeks, the Pessary was removed from 107 women; 70 delivered within 48 hours. The most common reasons for Pessary removal in these women were preterm premature rupture of the membranes, vaginal bleeding, contractions, and induction of labor. The composite poor perinatal outcome occurred in 53 women (13%) and 55 women (14%) in the Pessary and control groups, respectively (relative risk (RR), 0.98; 95% confidence interval, 0.69-1.39). Ten stillbirths (2%) occurred in each group. The other conditions within the composite outcome did not differ between the 2 groups. In the Pessary and control groups, 16 and 18 infants, respectively, died before discharge. The groups were similar in median gestational age at delivery; frequencies of delivery at less than 28, less than 32, and less than 37 weeks; and frequency and length of neonatal intensive care unit admission. In the women with a cervical length of less than 25th percentile ( <38 mm), the Pessary significantly reduced the frequency of poor perinatal outcomes and very preterm delivery. A cervical Pessary does not necessarily prevent poor perinatal outcomes or preterm birth in all women with a multiple gestation. Although the Pessary had a positive effect in women with a twin pregnancy and a short cervix, these results should be confirmed in additional prospective studies. The safety and low cost of the Pessary should be considered when counseling a parturient with a multiple pregnancy and short cervix

  • cervical pessaries for prevention of preterm birth in women with a multiple pregnancy protwin a multicentre open label randomised controlled trial
    Obstetrical & Gynecological Survey, 2014
    Co-Authors: Sophie Liem, Ewoud Schuit, Maud A Hegeman, Joke M J Bais, Karin De Boer, Kitty W M Bloemenkamp, Jozien T J Brons, Hans Duvekot, Bas Nij Bijvank, Maureen T M Franssen
    Abstract:

    Women with multiple gestations often deliver at less than 37 weeks, increasing the risks of perinatal morbidity and mortality. Treatment with a Pessary might prevent preterm birth by changing the inclination of the cervical canal and preventing premature dilatation of the cervix, rupture of the membranes, and deterioration or loss of the cervical mucous plug. This multicenter, open-label, randomized controlled trial at 40 hospitals was performed to determine whether a cervical Pessary could prevent poor perinatal outcomes in parturients with a multiple pregnancy. At 12 to 20 weeks' gestation, patients were assigned to the Pessary or control group; cervical length was measured at 16 to 22 weeks. Women in the study group received an Arabin Pessary at 16 to 20 weeks, which was removed in week 36 or in case of preterm premature rupture of the membranes, active vaginal bleeding, other signs of preterm labor, or patient discomfort. Obstetric care was otherwise similar in the 2 groups. The primary outcome was a composite of poor perinatal outcomes, including stillbirth, preventricular leukomalacia, severe respiratory distress syndrome, bronchopulmonary dysplasia, intraventricular hemorrhage, necrotizing enterocolitis, sepsis, and neonatal death within 6 weeks after the anticipated term date. Secondary outcomes were time to delivery, preterm birth at less than 32 and less than 37 weeks, days in the neonatal intensive care unit, days of maternal admission for preterm labor, and maternal morbidity. A total of 401 of 403 women in the Pessary group and 407 of 410 in the control group completed the study. Five women in the Pessary group had a surgical cerclage; 1 patient died, and the others delivered at 21.6 to 36.7 weeks, with 3 having poor perinatal outcomes. No patients in the control group had a cerclage. Vaginal discharge occurred in 104 women (26%) in the Pessary group and in none of the controls. The Pessary was removed from 57 women (14%) at less than 28 weeks and from 22 women (5%) at 28 to 32 weeks; 7 and 13, respectively, delivered within 48 hours of removal. At 32 to 36 weeks, the Pessary was removed from 107 women; 70 delivered within 48 hours. The most common reasons for Pessary removal in these women were preterm premature rupture of the membranes, vaginal bleeding, contractions, and induction of labor. The composite poor perinatal outcome occurred in 53 women (13%) and 55 women (14%) in the Pessary and control groups, respectively (relative risk (RR), 0.98; 95% confidence interval, 0.69-1.39). Ten stillbirths (2%) occurred in each group. The other conditions within the composite outcome did not differ between the 2 groups. In the Pessary and control groups, 16 and 18 infants, respectively, died before discharge. The groups were similar in median gestational age at delivery; frequencies of delivery at less than 28, less than 32, and less than 37 weeks; and frequency and length of neonatal intensive care unit admission. In the women with a cervical length of less than 25th percentile (

Jack Ludmir - One of the best experts on this subject based on the ideXlab platform.

  • prevention of preterm birth with Pessary in singletons popps randomized controlled trial
    Ultrasound in Obstetrics & Gynecology, 2018
    Co-Authors: Lorraine Dugoff, Vincenzo Berghella, Harish M Sehdev, A D Mackeen, Laura Goetzl, Jack Ludmir
    Abstract:

    Objective To determine if Pessary use prevents preterm birth in singleton gestations with a short transvaginal ultrasound cervical length and without a prior spontaneous preterm birth. Methods In this open-label multicenter randomized trial we enrolled asymptomatic women with singleton gestations with a transvaginal ultrasound cervical length ≤ 25 mm at 180-236 weeks and no prior spontaneous preterm birth. Subjects were randomized to receive the Bioteque cup Pessary or no Pessary. Pessaries were inserted by trained maternal fetal medicine staff.. Vaginal progesterone was recommended to women with a cervical length ≤20mm. The primary outcome was preterm birth < 37weeks. A sample size of 121 per group (n=242) was needed to detect a reduction in the primary outcome from 30% in the no Pessary group to 15% in the Pessary group. The trial was stopped early before complete enrollment. Results From March 17, 2014 through July 29, 2016, 17,383 women were screened with transvaginal ultrasound cervical length. 422 (2.4 %) had a cervical length ≤25mm. 391 (92.7 %) met eligibility criteria and 122 (31.2 %) of eligible subjects agreed to randomization. Sixty-one (50%) women were randomized to the Pessary and 61 (50%) to the no Pessary groups. Baseline characteristics were similar between groups. There were no significant differences between the Pessary and no Pessary groups in rates of the primary outcome, preterm birth <37weeks (43% vs 40%, RR 1.09, 95% CI 0.71, 1.68), as well as other outcomes, such as preterm birth <34 weeks, preterm birth <28 weeks, gestational age at delivery, birth weight and composite adverse neonatal outcome. Discussion Cervical Pessary use was not associated with prevention of preterm birth in women with singleton gestations with a short transvaginal ultrasound cervical length and without a prior spontaneous preterm birth in this small underpowered randomized controlled trial. This trial was registered on ClinicalTrials.gov, number NCT 02056652.

  • prevention of preterm birth with Pessary in twins poppt a randomized controlled trial
    Ultrasound in Obstetrics & Gynecology, 2017
    Co-Authors: Vincenzo Berghella, Lorraine Dugoff, Jack Ludmir
    Abstract:

    Objective To evaluate whether cervical Pessary placement prevents preterm birth (PTB) in twin gestations with a short mid-trimester cervical length (CL) on transvaginal sonography (TVS). Methods This was a multicenter randomized controlled trial of asymptomatic women with a twin gestation and a TVS-CL of ≤ 30 mm at 18 + 0 to 27 + 6 weeks' gestation. TVS-CL was measured at the time of the fetal anatomy scan at 18 + 0 to 23 + 6 weeks and at subsequent scheduled ultrasound scans prior to 28 weeks. Women with a TVS-CL of ≤ 30 mm at 18 + 0 to 27 + 6 weeks were randomized to receive either the Bioteque™ cup cervical Pessary or no Pessary. Randomization was stratified by gestational age, study site and chorionicity. Women with a monoamniotic twin gestation, twin–twin transfusion syndrome, early selective intrauterine growth restriction or placenta previa were excluded. Cervical pessaries were inserted by maternal-fetal medicine staff centrally trained in proper placement. No other treatment for women with a short cervix was recommended. Primary outcome was PTB < 34 weeks. The trial was stopped early before complete enrollment. Results A total of 421 women with a twin gestation were screened for TVS-CL, and 85 (20%) had a TVS-CL of ≤ 30 mm. Of these, 80 (94%) met the eligibility criteria and 46 (58%) of the eligible women agreed to randomization. Twenty-three (50%) women were randomized to Pessary placement and 23 (50%) to no Pessary. Demographic characteristics, including median gestational age (21.0 vs 21.2 weeks; P = 0.69) and TVS-CL (16.7 vs 22.9 mm; P = 0.45) at randomization, were similar between the Pessary and no-Pessary groups, except for level of education (more than high school education: 48% vs 78%, respectively; P = 0.03) and proportion of spontaneous conceptions (83% vs 43%, respectively; P = 0.01). There were no significant differences between the Pessary and no-Pessary groups in rate of primary outcome, PTB < 34 weeks (39% vs 35%; relative risk, 1.13 (95% CI, 0.53–2.40)), as well as other outcomes, including PTB < 37 weeks and < 28 weeks, gestational age at delivery, birth weight and composite adverse neonatal outcome. Conclusion Treatment with cervical Pessary was not associated with the prevention of PTB in women with a twin gestation and a mid-trimester TVS-CL of ≤ 30 mm in this small underpowered randomized controlled trial. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd.

  • cervical Pessary for preventing preterm birth in twin pregnancies with short cervical length a systematic review and meta analysis
    Journal of Maternal-fetal & Neonatal Medicine, 2017
    Co-Authors: Gabriele Saccone, Lorraine Dugoff, Jack Ludmir, Andrea Ciardulli, Serena Xodo, F Dantonio, S Boito, Elena Olearo, Carmela Votino, Giuseppe Maria Maruotti
    Abstract:

    AbstractObjective: To evaluate the effectiveness of cervical Pessary for preventing spontaneous preterm birth (SPTB) in twin pregnancies with an asymptomatic transvaginal ultrasound cervical length (TVU CL) in the second trimester.Methods: We performed a meta-analysis including all randomized clinical trials (RCTs) comparing the use of cervical Pessary (i.e. intervention group) with expectant management (i.e. control group). The primary outcome was incidence of SPTB <34 weeks.Results: Three trials, including 481 twin pregnancies with short cervix, were analyzed. Two RCTs defined short cervix as TVU CL ≤25 mm and one as TVU CL ≤38 mm. Pessary was not associated with prevention of SPTB, and the mean gestational age at delivery and the mean latency were similar in the Pessary group compared to the control group. Moreover, no benefits were noticed in neonatal outcomes.Conclusions: Use of the Arabin Pessary in twin pregnancies with short TVU CL at 16–24 weeks does not prevent SPTB or improve perinatal outcome.

  • alternative treatment for a short cervix the cervical Pessary
    Seminars in Perinatology, 2009
    Co-Authors: Vanita B Dharan, Jack Ludmir
    Abstract:

    Preterm birth is the leading cause of perinatal morbidity and mortality in the United States. The risk of preterm birth is inversely proportional to the length of the cervix on transvaginal sonography. The traditional treatment for a short cervix has been cerclage and recently there are newer trials using progesterone for this same indication. This manuscript reviews the published data regarding the use of an old method for the treatment of cervical insufficiency, "The Cervical Pessary." A MEDLINE search was performed and articles published since 1959 regarding the use of Pessary for cervical insufficiency were identified and reviewed. The Pessary may represent an easy and safe intervention in the treatment of a short cervix diagnosed in the midtrimester. Further research is merited to evaluate the role of the cervical Pessary as an alternative treatment for a short cervix or for women at high risk for preterm birth.

Maria Goya - One of the best experts on this subject based on the ideXlab platform.

  • should phenotype of previous preterm birth influence management of women with short cervix in subsequent pregnancy comparison of vaginal progesterone and arabin Pessary
    Ultrasound in Obstetrics & Gynecology, 2019
    Co-Authors: Angharad Care, Maria Goya, Bertram Mullermyhsok, E Olearo, Tullia Todros, Javier Caradeux, M Palacio, E Carreras, Zarko Alfirevic
    Abstract:

    OBJECTIVE To investigate whether the classification of a previous spontaneous preterm birth (sPTB) as preterm labor (PTL) with intact membranes (IM) or as preterm prelabor rupture of membranes (PPROM) impacts the efficacy of cervical Pessary or vaginal progesterone for prevention of sPTB in pregnant women with short cervix on transvaginal ultrasound. METHODS This was a retrospective cohort study of asymptomatic high-risk singleton pregnancies with a short cervix and history of sPTB, treated using Arabin Pessary or vaginal progesterone for primary PTB prevention, conducted at four European hospitals. A log-rank test on Kaplan-Meier curves was used to assess the difference in performance of Pessary and progesterone, according to history of PTL-IM or PPROM. Linear regression analysis was used to evaluate significant predictors of gestational age at delivery. RESULTS Between 2008 and 2015, 170 women were treated with a Pessary and 88 with vaginal progesterone. In women treated with a Pessary, rate of sPTB < 34 weeks was 16% in those with a history of PTL-IM and 55% in those with a history of PPROM. In women treated with progesterone, rate of sPTB < 34 weeks was 13% in those with a history of PTL-IM and 21% in those with a history of PPROM. Treatment with a Pessary resulted in earlier delivery in women with previous PPROM than in any other subgroup (P < 0.0001). Linear regression analysis showed a clear effect of PPROM history (P < 0.0001), combination of PPROM history and treatment (P = 0.0003) and cervical length (P = 0.0004) on gestational age at birth. CONCLUSIONS Cervical Pessary may be a less efficacious treatment option for women with previous PPROM; however, these results require prospective validation before change in practice is recommended. Phenotype of previous preterm birth may be an important risk predictor and treatment effect modifier; this information should be reported in future clinical trials. © 2018 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of the International Society of Ultrasound in Obstetrics and Gynecology.

  • modification of cervical length after cervical Pessary insertion correlation weeks of gestation
    Journal of Maternal-fetal & Neonatal Medicine, 2017
    Co-Authors: Manel Mendoza, Maria Goya, Andrea Gascon, Laia Pratcorona, Carme Merced, Carlota Rodo, Leonor Valle, A H Romero, Miquel Juan, Alberto Muniz Rodriguez
    Abstract:

    AbstractObjectives: To observe the modifications in cervical length (CL) in patients with and without cervical Pessary (Arabin® ASQ 65/25/32) and correlate these modifications with gestational age at delivery.Study design: Prospective study of asymptomatic singleton pregnancies (PECEP-Trial) between weeks 20 + 0 and 23 + 6 with maternal short cervix (<25 mm) randomised into two groups: expectant management and cervical Pessary.Results: This study included 380 pregnant women: 190 with Pessary and 190 without Pessary. Mean CL in both groups at the time of randomisation showed no statistically-significant differences (Pessary group: 19.0 mm and management group: 19.0 mm; p = 0.9). Mean CL measured after randomisation was 15.4 mm in patients of the expectant management group and 21.5 mm in the Pessary group. These differences were statistically significant (p < 0.0001). When means at randomisation and at the second measurement were compared, CL had decreased by 3.6 mm in the expectant management group and inc...

  • cervical Pessary to prevent preterm birth in women with twin gestation and sonographic short cervix a multicenter randomized controlled trial pecep twins
    American Journal of Obstetrics and Gynecology, 2016
    Co-Authors: Maria Goya, Laia Pratcorona, Carme Merced, Carlota Rodo, Miquel Juan, Maria De La Calle, B Munoz, Ariana Serrano, Elisa Llurba, T Higueras
    Abstract:

    Background Spontaneous preterm birth (SPB) is the leading cause of perinatal morbidity and mortality. In twins, the rate of preterm birth is higher than in singletons; interventions to prevent preterm birth are needed in this high-risk population. Objective We sought to test whether a cervical Pessary reduces the preterm birth rate in twin pregnancies with sonographic short cervix. Study Design A prospective, open-label, multicenter, randomized clinical trial was conducted in 5 hospitals in Spain. The ethics committees of all participating hospitals approved the protocol. The trial was registered as ClinicalTrials.gov, number NCT01242410. Eligible women were scanned in Spain. The primary outcome was SPB Results Cervical length was measured in 2287 women; 137 pregnant women with a sonographic cervical length ≤25 mm (of 154 detected with a short cervix) were randomly assigned to receive a cervical Pessary or expectant management (1:1 ratio). SPB P  = .01). No significant differences were observed in composite neonatal morbidity outcome (8/136 [5.9%] vs 12/130 [9.1%]; relative risk, 0.64; 95% confidence interval, 0.27-1.50) or neonatal mortality (none) between the groups. No serious adverse effects associated with the use of a cervical Pessary were observed. Conclusion The insertion of a cervical Pessary was associated with a significant reduction in the SPB rate. We propose the use of a cervical Pessary for preventing preterm birth in twin pregnancies of mothers with a short cervix.

  • cervical Pessary in pregnant women with a short cervix pecep an open label randomised controlled trial
    The Lancet, 2012
    Co-Authors: Maria Goya, Laia Pratcorona, Carme Merced, Carlota Rodo, Leonor Valle, A H Romero, Miquel Juan, Alberto Muniz Rodriguez, B Munoz
    Abstract:

    Summary Background Most previous studies of the use of cervical pessaries were either retrospective or case controlled and their results showed that this intervention might be a preventive strategy for women at risk of preterm birth; no randomised controlled trials have been undertaken. We therefore undertook a randomised, controlled trial to investigate whether the insertion of a cervical Pessary in women with a short cervix identified by use of routine transvaginal scanning at 20–23 weeks of gestation reduces the rate of early preterm delivery. Methods The Pesario Cervical para Evitar Prematuridad (PECEP) trial was undertaken in five hospitals in Spain. Pregnant women (aged 18–43 years) with a cervical length of 25 mm or less were randomly assigned according to a computer-generated allocation sequence by use of central telephone in a 1:1 ratio to the cervical Pessary or expectant management (without a cervical Pessary) group. Because of the nature of the intervention, this study was not masked. The primary outcome was spontaneous delivery before 34 weeks of gestation. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00706264. Findings 385 pregnant women with a short cervix were assigned to the Pessary (n=192) and expectant management groups (n=193), and 190 were analysed in each group. Spontaneous delivery before 34 weeks of gestation was significantly less frequent in the Pessary group than in the expectant management group (12 [6%] vs 51 [27%], odds ratio 0·18, 95% CI 0·08–0·37; p Interpretation Cervical Pessary use could prevent preterm birth in a population of appropriately selected at-risk women previously screened for cervical length assessment at the midtrimester scan. Funding Instituto Carlos III.

Dick J Bekedam - One of the best experts on this subject based on the ideXlab platform.

  • child outcomes after placement of a cervical Pessary in women with a multiple pregnancy a 4 year follow up of the protwin trial
    Acta Obstetricia et Gynecologica Scandinavica, 2019
    Co-Authors: Noor E Simons, Sophie Liem, Ewoud Schuit, Brent C Opmeer, Leonie J P Steenis, Cornelieke Van De Beek, Johanna H Van Der Lee, Aleid G Van Wassenaerleemhuis, Anneloes L Van Baar, Dick J Bekedam
    Abstract:

    Introduction: The ProTWIN trial previously showed no beneficial effect of treatment with a cervical Pessary vs usual care to prevent preterm birth in women with a multiple pregnancy. However, in women with a midtrimester short cervix (<38 mm), Pessary did reduce the composite outcome of neonatal morbidity and mortality. This follow-up study evaluates the long-term outcomes of all children born to mothers who participated in the ProTWIN trial at 4 years of age. Material and methods: Parents received the Ages and Stages Questionnaire, Strength and Difficulties Questionnaire and a health questionnaire. All questionnaires were reported separately and as a combined outcome (abnormal child outcome). A linear mixed effects model was used to adjust for correlated data in twins and correction for confounders was performed. In exploratory analysis, a composite outcome of death or survival with abnormal child outcome was used by combining extrapolated data on child outcome with survival data. All data were analyzed for the total group and the subgroup of women with midtrimester short cervix. Results: Of the original 813 women of the ProTWIN trial, we approached 579, of whom 258 participated (45%) in follow up. We received questionnaires of 514 children (281 Pessary vs 233 control), with 119 children in the subgroup of women with midtrimester short cervix. An abnormal child outcome was found in 23% in the Pessary group vs 16% in the control group (odds ratio 1.58; 95% confidence interval.94-2.65). In exploratory analysis with extrapolated data on child outcome (n = 815), no difference in abnormal child outcome was seen between the Pessary and control group. In the subgroup of women with a short cervix (n = 268), this composite outcome indicated a favorable outcome for children born to mothers with Pessary. Conclusions: In women with a multiple pregnancy, the use of a cervical Pessary did not improve development, behavior or physical outcomes of the surviving children at age 4.

  • Pessary for prevention of preterm birth in twin pregnancy with short cervix 3 year follow up study
    Ultrasound in Obstetrics & Gynecology, 2018
    Co-Authors: J Van T Hooft, Ewoud Schuit, Dick J Bekedam, Brent C Opmeer, J H Van Der Lee, A G Van Wassenaerleemhuis, A L Van Baar, Leonie J P Steenis, S M S Liem, Cuny Cuijpers
    Abstract:

    Objective A recent randomized clinical trial (ProTWIN) showed that a cervical Pessary prevented preterm birth and improved neonatal outcome in women with multiple pregnancy and cervical length (CL) < 38 mm. In this follow‐up study, the long‐term developmental outcome of these children was evaluated at 3 years' corrected age. Methods This was a follow‐up study of ProTWIN, a multicenter trial conducted between 2009 and 2012 in which asymptomatic women with a multiple pregnancy were randomized to placement of a cervical Pessary or no intervention. Current follow‐up and analysis were limited to mothers with a mid‐trimester CL < 38 mm (78 women (157 children) in the Pessary group and 55 women (111 children) in the control group). At 3 years of corrected age, surviving children were invited for a Bayley Scales of Infant and Toddler Development‐third edition (Bayley‐III) assessment. Death after randomization or neurodevelopmental disability (Bayley‐III score of ≤ 85, 1 SD below mean) rates were compared between the Pessary and control groups, according to the intention‐to‐treat principle and using multiple imputation for missing data. Mean Bayley‐III scores in surviving children were also assessed. A linear mixed‐effects model was used to adjust for correlation between children of one mother. Results From the time of entry in the ProTWIN trial until follow‐up at 3 years of age, a total of 27 children had died (six (5%) in the Pessary vs 21 (26%) in the control group; odds ratio (OR), 0.13; 95% CI, 0.04–0.48). Bayley‐III outcomes were collected for 173/241 (72%) surviving children (114 (75%) in the Pessary vs 59 (66%) in the control group). The cumulative incidence of death or survival with a neurodevelopmental disability was 12 (10%) in the Pessary vs 23 (29%) in the control group (OR, 0.26; 95% CI, 0.09–0.73). No statistical or clinically relevant differences were found with respect to cognitive, language and motor development among surviving children between the groups. Comparable results were found after multiple imputation. Conclusion In women with twin pregnancy and a CL < 38 mm, the use of a cervical Pessary strongly improved survival of the children without affecting neurodevelopment at 3 years' corrected age. Copyright © 2018 ISUOG. Published by John Wiley & Sons Ltd.

  • cervical pessaries to prevent preterm birth in women with a multiple pregnancy a per protocol analysis of a randomized clinical trial
    Acta Obstetricia et Gynecologica Scandinavica, 2016
    Co-Authors: Sophie Liem, Ewoud Schuit, Marielle G Van Pampus, Marjo J G J Van Melick, Maurice J M Monfrance, Josje Langenveld, Ben Willem J Mol, Dick J Bekedam
    Abstract:

    Introduction We recently showed that a cervical Pessary prevents preterm birth and reduces poor neonatal outcomes in women with a twin pregnancy and a short cervix (<38 mm). The objective of this study was to evaluate the full potential treatment effect of the Pessary in the whole group and in women with a short cervix. Material and methods We performed a per-protocol analysis of a multicenter randomized controlled trial (ProTWIN trial, NTR1858) where we excluded women who were allocated to the Pessary but never had it placed. Women who had the Pessary removed before 36 gestational weeks and did not deliver within 7 days after removal, were excluded. Analyses were performed on all women and in those with a cervical length <38 mm. Results In 23 (6%) women the Pessary was not placed. In women with a cervical length <38 mm (25th percentile) the Pessary reduced poor perinatal outcome (relative risk 0.32, 95% confidence interval 0.13–0.78) and birth at <32 weeks (relative risk 0.41, 95% confidence interval 0.20–0.87). After excluding 47 (12%) women, the time to delivery was longer in the Pessary group than in the control group (whole group: hazard ratio 0.68, 95% confidence interval 0.55–0.82, cervical length <38 mm: hazard ratio 0.35, 95% confidence interval 0.22–0.57). Conclusions The analysis confirms the principal findings of the intention-to-treat analysis. Time to delivery was longer in the Pessary group than in the control group when censored data were used. This implies the Pessary should not be removed until labor is evident.

  • pessaries in multiple pregnancy as a prevention of preterm birth the protwin trial
    BMC Pregnancy and Childbirth, 2009
    Co-Authors: Maud A Hegeman, Kitty W M Bloemenkamp, Dick J Bekedam, Anneke Kwee, Dimitri N M Papatsonis, Joris A M Van Der Post, Hubertina C J Scheepers, Christine Willekes, Johannes J Duvekot, Marc E A Spaanderman
    Abstract:

    Background: Multiple pregnancies are at high risk for preterm birth, and therefore an important cause of infant mortality and morbidity. A Pessary is a simple and potentially effective measure for the prevention of preterm birth. Small studies have indicated its effectiveness, but large studies with sufficient power on the subject are lacking. Despite this lack of evidence, the treatment is at present applied by some gynaecologists in The Netherlands. Methods/Design: We aim to investigate the hypothesis that prophylactic use of a cervical Pessary will be effective in the prevention of preterm delivery and the neonatal mortality and morbidity resulting from preterm delivery in multiple pregnancy. We will evaluate the costs and effects of this intervention. At study entry, cervical length will be measured. Eligible women will be randomly allocated to receive either a cervical Pessary or no intervention. The cervical Pessary will be placed in situ at 16 to 20 weeks, and will stay in situ up to 36 weeks gestation or until delivery, whatever comes first.