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Anthony Sciscione - One of the best experts on this subject based on the ideXlab platform.

  • blown out of proportion induction Foley balloon ruptures associated with overinflation
    American Journal of Obstetrics & Gynecology MFM, 2019
    Co-Authors: Corina N Schoen, Anthony Sciscione, Kimberly W Keefe, Vincenzo Berghella, Christian M Pettker
    Abstract:

    Background Larger volume Foley catheters are occasionally used for labor induction. In some instances the balloon is overinflated to obtain this volume. Neither the risk or rate of rupture are known for this practice. Objective The purpose of this study was to evaluate the use of overinflated Foley catheter balloons and the rate of rupture in prospective trials and to describe rupture events in our institutions. Study Design Clinical trials and prospective cohorts were identified through a search of MEDLINE from 2000 through May 1, 2017; prospective studies were examined for the use of overinflated Foley catheters. Reports of overinflated balloons were then reviewed in detail to determine if rupture occurred and to record any reported maternal, neonatal, or gynecologic outcomes. Internal reports to the Obstetric Safety Report System were used to describe the local cases at our institutions. Results We reviewed 296 abstracts. Seventeen prospective cohorts or randomized trials used larger balloon volumes (≥50 mL), of which 12 abstracts confirmed routine overinflation of the balloon. Within these studies, 19 patients who underwent cervical ripening with overinflated Foley catheters experienced balloon rupture during use. The incidence of rupture in these studies was 0.9%. No adverse maternal or fetal effects were noted. Internal safety reporting yielded an additional case. One gynecologic case was identified internally. The patient had an overinflated Foley catheter balloon used to tamponade excessive uterine bleeding after uterine evacuation. Balloon rupture was noted, and hysteroscopy was needed to remove fragments of the balloon. Conclusion Overinflation of Foley catheter balloons in obstetric and gynecologic applications may cause rupture. Because of possible underreporting, the extent of complications that may result from balloon rupture is unknown.

  • Foley plus oxytocin compared with oxytocin for induction after membrane rupture a randomized controlled trial
    Obstetrics & Gynecology, 2017
    Co-Authors: Dhanya A Mackeen, Danielle E Durie, Monique Lin, Christopher Kevin Huls, Emma Qureshey, Michael J Paglia, Haiyan Sun, Anthony Sciscione
    Abstract:

    OBJECTIVE To evaluate the use of a transcervical Foley catheter plus oxytocin infusion compared with oxytocin infusion alone for labor induction and cervical ripening in women 34 weeks of gestation or greater with prelabor rupture of membranes. METHODS This is a randomized, multicenter trial of women with a live, singleton gestation at 34 weeks of gestation or greater with prelabor rupture of membranes, an unfavorable cervical examination (less than or equal to 2 cm dilated and less than or equal to 80% effaced), and no contraindication to labor. Participants were randomly allocated to a transcervical Foley catheter inflated to 30 cc with concurrent oxytocin infusion or oxytocin infusion alone. Oxytocin administration was standardized across sites. The primary study outcome was interval from induction to delivery. To detect a 2.5-hour difference in the interval from induction to delivery, we required outcome data on 194 women, assuming 80% power and a two-tailed α of 5%. Analysis was by intent to treat. RESULTS We enrolled 201 women: 93 were allocated to Foley and 108 to oxytocin. Demographics were similar between the groups. Time to delivery was not significantly different between groups: in the Foley group, it was 13.9 hours (±6.9 SD) compared with 14.4 hours (±7.9 SD) in the oxytocin group (P=.69). There were more cases of clinical chorioamnionitis (8% compared with 0%, P<.01) in the Foley group compared with the oxytocin group. There were no differences for other infectious morbidities or any other variable studied. CONCLUSION In patients with prelabor rupture of membranes, the use of a transcervical Foley catheter in addition to oxytocin does not shorten the time to delivery compared with oxytocin alone, but may increase the incidence of intraamniotic infection. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, NCT01973036.

  • the timing of adverse events with Foley catheter preinduction cervical ripening implications for outpatient use
    American Journal of Perinatology, 2013
    Co-Authors: Anthony Sciscione, Casey L Bedder, Matthew K Hoffman, Kelly Ruhstaller, Phillip Shlossman
    Abstract:

    Objective We sought to determine the rate and timing of adverse events that occur during preinduction cervical ripening using the Foley catheter before extrusion of the balloon and institution of oxytocin. Study Design Using electronic medical records, we identified all women who presented for preinduction cervical ripening using a Foley catheter with a term (≥37 weeks) singleton vertex live fetus from January 1, 2006, to June 14, 2009. Women were excluded if they had had a previous cesarean delivery, gestational hypertension or preeclampsia, pregestational diabetes, rupture of membranes before induction, fetal anomaly, or antepartum stillbirth. Outcomes were cesarean delivery for nonreassuring fetal tracing, vaginal bleeding, placental abruption, or intrapartum stillbirth occurring between 2 hours after Foley catheter placement and 6 am . Results Among 2,514 women, 1,905 met the inclusion criteria. No adverse outcomes were noted among term, singleton uncomplicated pregnancies receiving a Foley catheter for preinduction cervical ripening who met inclusion criteria (relative risk, 0.0; 95% confidence interval, 0.0–0.002). Conclusions In a low-risk population, the use of the Foley catheter for preinduction cervical ripening was associated with no adverse outcomes. It appears to be a safe mechanism for cervical ripening and has the potential for use in the outpatient setting in a selected subset of women.

  • a randomized comparison of transcervical Foley catheter to intravaginal misoprostol for preinduction cervical ripening
    Obstetrics & Gynecology, 2001
    Co-Authors: Anthony Sciscione, James S Manley, Marjorie Pollock, Lisa Nguyen, Bridget Maas, Garrett H C Colmorgen
    Abstract:

    Objective: To compare the efficacy of intravaginal misoprostol tablets with transcervical Foley catheter for preinduction cervical ripening. Methods: Pregnant women who presented for induction of labor with unfavorable cervices (Bishop score less than 6) were assigned randomly to intravaginal misoprostol (50 μg tablet every 4 hours for a maximum of six doses) or 30-mL Foley catheter placed transcervically with maintenance of traction. Results: Among 111 women, 53 were allocated to misoprostol and 58 to Foley bulb. Contractile abnormalities were more frequent in the misoprostol group (20.4%) than the Foley group (0%) (P < .001). No statistically significant differences were noted between groups in change in Bishop score, preinduction cervical ripening times, and total induction times. There were no statistically significant differences in mode of delivery or adverse neonatal outcomes. Uterine rupture occurred in one woman with two previous cesarean deliveries in the misoprostol group. Conclusion: Intravaginal misoprostol and transcervical Foley catheter are equivalent for cervical ripening. Uterine contractile abnormalities and meconium passage are more common with misoprostol.

  • a prospective randomized comparison of Foley catheter insertion versus intracervical prostaglandin e2 gel for preinduction cervical ripening
    American Journal of Obstetrics and Gynecology, 1999
    Co-Authors: Anthony Sciscione, Helen Mccullough, James S Manley, Philip Shlossman, Marjorie Pollock, Garrett H C Colmorgen
    Abstract:

    Abstract Objective: The objective of this study was to compare intracervical prostaglandin E 2 gel with insertion of a Foley bulb for efficacy in preinduction cervical ripening. Study Design: Women who came to the hospital for induction of labor with a Bishop score ≤5 were randomly assigned to treatment with either prostaglandin E 2 gel or a Foley bulb. Prostaglandin E 2 gel was used according to the manufacturer's recommendation. The Foley group had a number 14 Foley catheter inserted, inflated, and placed on traction. Immediately after Foley bulb extrusion or 6 hours after prostaglandin E 2 gel course completion, a dilute oxytocin solution was started if the patient was not in labor. Results: Seventy-seven women were entered into the Foley group and 72 were entered into the prostaglandin E 2 gel group. Both the Bishop score after preinduction ripening (6.5 vs 5.1, P P = .015) were significantly higher in the Foley group. There were no differences between the groups in mode of delivery, infant weight, rate of hyperstimulation, shoulder dystocia, patient discomfort, epidural use, oxytocin use, or nonreassuring fetal heart rate patterns. The preinduction time (9.9 vs 17.2 hours, P P P Conclusion: Use of the Foley catheter resulted in a higher postinduction Bishop score, a greater change in Bishop score, a shorter induction time, and lower patient charges than did intracervical prostaglandin E 2 gel. (Am J Obstet Gynecol 1999;180:55-9.)

Mieke Ten L G Eikelder - One of the best experts on this subject based on the ideXlab platform.

  • induction of labour at term with oral misoprostol versus a Foley catheter probaat ii a multicentre randomised controlled non inferiority trial
    Obstetrical & Gynecological Survey, 2016
    Co-Authors: Mieke Ten L G Eikelder, Marta Jozwiak, Katrien Oude Rengerink, Marielle G Van Pampus, Jan Willem De Leeuw, Irene M De Graaf, Marloes Holswilder, Martijn A Oudijk, Gert Jan Van Baaren, Paula J M Pernet
    Abstract:

    When pregnancy complications pose a threat to the mother or fetus or both, induction of labor is often required. Induction of labor is accomplished through a variety of methods; in pregnant women having an unfavourable cervix, cervical ripening of the cervix is accomplished through various mechanical and pharmacological means. Oral misoprostol and Foley catheter are believed to be equally effective in women with an unfavorable cervix in accomplishing vaginal birth. The current open-label randomized noninferiority trial was conducted in pregnant women with a singleton gestation in 29 hospitals in the Netherlands (2012 to 2013) to directly compare oral misoprostol with Foley catheter. Women with a viable singleton pregnancy in cephalic presentation, intact membranes, gestational age of 37 weeks or more, and an unfavorable cervix were included in the trial. The women were then randomly allocated (1:1) to oral misoprostol (n = 932) or Foley catheter (n = 927). Oral misoprostol dosage given was 50 µg orally once every 4 hours with a maximum of 3 times a day. Placement of a 30-mL Foley catheter in the cervix was done either digitally or using a vaginal speculum. The results of the study showed that the primary outcome (asphyxia or postpartum hemorrhage) occurred in 12.2% women in the misoprostol group and in 11.5% women in the Foley catheter group (adjusted relative risk [RR], 1.06; 90% confidence interval [CI], 0.86–1.31). Cesarean delivery resulted in 16.8% of labors in the misoprostol group and in 20.1% of the time in the Foley catheter group (no significant difference between groups [RR, 0.84; 95% CI, 0.69–1.01]). When the indication for cesarean delivery was examined, fewer cesarean deliveries for failure to progress in the first stage occurred after induction in the misoprostol group than in the Foley catheter group (6.2% vs 10.6%; RR, 0.58; 95% CI, 0.42–0.79). In addition, operative vaginal delivery occurred more frequently in the misoprostol group. Among the misoprostol group spontaneous membrane rupture was more common and labor augmentation with oxytocin was less likely. The study leads to a conclusion that in terms of safety and effectiveness, induction of labour using oral misoprostol is as safe as mechanical induction using Foley catheter.

  • women s experiences with and preference for induction of labor with oral misoprostol or Foley catheter at term
    American Journal of Perinatology, 2016
    Co-Authors: Mieke Ten L G Eikelder, Marta Jozwiak, Katrien Oude Rengerink, Marieke M Van De Meent, Kelly Mast, Irene De Graaf, Marloes Holswilderolde A G Scholtenhuis, Frans J M E Roumen, Martina Porath, Aren J Van Loon
    Abstract:

    Objective We assessed experience and preferences among term women undergoing induction of labor with oral misoprostol or Foley catheter. Study Design In 18 of the 29 participating hospitals in the PROBAAT-II trial, women were asked to complete a questionnaire within 24 hours after delivery. We adapted a validated questionnaire about expectancy and experience of labor and asked women whether they would prefer the same method again in a future pregnancy. Results The questionnaire was completed by 502 (72%) of 695 eligible women; 273 (54%) had been randomly allocated to oral misoprostol and 229 (46%) to Foley catheter. Experience of the duration of labor, pain during labor, general satisfaction with labor, and feelings of control and fear related to their expectation were comparable between both the groups. In the oral misoprostol group, 6% of the women would prefer the other method if induction is necessary in future pregnancy, versus 12% in the Foley catheter group (risk ratio: 0.70; 95% confidence interval: 0.55-0.90; p = 0.02). Conclusion Women's experiences of labor after induction with oral misoprostol or Foley catheter are comparable. However, women in the Foley catheter group prefer more often to choose a different method for future inductions.

  • induction of labour at term with oral misoprostol versus a Foley catheter probaat ii a multicentre randomised controlled non inferiority trial
    The Lancet, 2016
    Co-Authors: Mieke Ten L G Eikelder, Marta Jozwiak, Katrien Oude Rengerink, Marielle G Van Pampus, Jan Willem De Leeuw, Irene M De Graaf, Marloes Holswilder, Martijn A Oudijk, Gert Jan Van Baaren, Paula J M Pernet
    Abstract:

    Summary Background Labour is induced in 20–30% of all pregnancies. In women with an unfavourable cervix, both oral misoprostol and Foley catheter are equally effective compared with dinoprostone in establishing vaginal birth, but each has a better safety profile. We did a trial to directly compare oral misoprostol with Foley catheter alone. Methods We did an open-label randomised non-inferiority trial in 29 hospitals in the Netherlands. Women with a term singleton pregnancy in cephalic presentation, an unfavourable cervix, intact membranes, and without a previous caesarean section who were scheduled for induction of labour were randomly allocated to cervical ripening with 50 μg oral misoprostol once every 4 h or to a 30 mL transcervical Foley catheter. The primary outcome was a composite of asphyxia (pH ≤7·05 or 5-min Apgar score Findings Between July, 2012, and October, 2013, we randomly assigned 932 women to oral misoprostol and 927 women to Foley catheter. The composite primary outcome occurred in 113 (12·2%) of 924 participants in the misoprostol group versus 106 (11·5%) of 921 in the Foley catheter group (adjusted relative risk 1·06, 90% CI 0·86–1·31). Caesarean section occurred in 155 (16·8%) women versus 185 (20·1%; relative risk 0·84, 95% CI 0·69–1·02, p=0·067). 27 adverse events were reported in the misoprostol group versus 25 in the Foley catheter group. None were directly related to the study procedure. Interpretation In women with an unfavourable cervix at term, induction of labour with oral misoprostol and Foley catheter has similar safety and effectiveness. Funding FondsNutsOhra.

  • Foley catheter or prostaglandin e2 inserts for induction of labour at term an open label randomized controlled trial probaat p trial and systematic review of literature
    European Journal of Obstetrics & Gynecology and Reproductive Biology, 2013
    Co-Authors: M Jozwiak, Mieke Ten L G Eikelder, Katrien Oude Rengerink, Marielle G Van Pampus, Marja G K Dijksterhuis, Irene De Graaf, Joris A M Van Der Post, Paulien C M Van Der Salm, Hubertina C J Scheepers, N Schuitemaker
    Abstract:

    Abstract Objective To assess the safety and effectiveness of a transcervical Foley catheter compared to vaginal prostaglandin E2 inserts for term induction of labour. Study design We conducted an open-label randomized controlled trial in five hospitals in the Netherlands. Women with a singleton term pregnancy in cephalic presentation, intact membranes, unfavourable cervix, and no prior caesarean section were enrolled. Participants were randomly allocated by a web-based randomization system to induction of labour with a 30 ml Foley catheter or 10 mg slow-release vaginal prostaglandin E2 inserts in a 1:1 ratio. Due to the nature of the intervention this study was not blinded. The primary outcome was the caesarean section rate. Secondary outcomes were maternal and neonatal morbidity and time from intervention to birth. Additionally, we carried out a systematic review and meta-analysis of similar studies. Results We analyzed 226 women: 107 received a Foley catheter and 119 inserts. Caesarean section rates were comparable (20% versus 22%, RR 0.90, 95% CI 0.54–1.50). Secondary outcomes showed no differences. We observed no serious maternal or neonatal morbidity. Meta-analysis showed comparable caesarean section rates, but significantly fewer cases of hyperstimulation during the ripening phase when a Foley catheter was used. Conclusions We found, in this relatively small study, no differences in effectiveness and safety of induction of labour with a Foley catheter and 10 mg slow release vaginal prostaglandin E2 inserts. Meta-analysis confirmed a comparable caesarean section rate, and showed fewer cases of hyperstimulation when a Foley catheter was used.

  • Foley catheter versus vaginal misoprostol randomized controlled trial probaat m study and systematic review and meta analysis of literature
    American Journal of Perinatology, 2013
    Co-Authors: Marta Jozwiak, Mieke Ten L G Eikelder, Katrien Oude Rengerink, Christianne J M De Groot, Hanneke Feitsma, Marc E A Spaanderman, Marielle G Van Pampus, Jan Willem De Leeuw, Ben Willem J Mol, Kitty W M Bloemenkamp
    Abstract:

    Objectives To assess effectiveness and safety of Foley catheter versus vaginal misoprostol for term induction of labor. Study Design This trial randomly allocated women with singleton term pregnancy to 30-mL Foley catheter or 25-μg vaginal misoprostol tablets. Primary outcome was cesarean delivery rate. Secondary outcomes were maternal and neonatal morbidity and time to birth. Additionally, a systematic review was conducted. Results Fifty-six women were allocated to Foley catheter, 64 to vaginal misoprostol tablets. Cesarean delivery rates did not differ significantly (25% Foley versus 17% misoprostol; relative risk [RR] 1.46, 95% confidence interval [CI] 0.72 to 2.94), with more cesarean deliveries due to failure to progress in the Foley group (14% versus 3%; RR 4.57, 95% CI 1.01 to 20.64). Maternal and neonatal outcomes were comparable. Time from induction to birth was longer in the Foley catheter group (36 hours versus 25 hours; p  Conclusion Our trial and meta-analysis showed no difference in cesarean delivery rates and less hyperstimulation with fetal heart rate changes and vaginal instrumental deliveries when using Foley catheter, thereby supporting potential advantages of the Foley catheter over misoprostol as ripening agent.

Marta Jozwiak - One of the best experts on this subject based on the ideXlab platform.

  • induction of labour at term with oral misoprostol versus a Foley catheter probaat ii a multicentre randomised controlled non inferiority trial
    Obstetrical & Gynecological Survey, 2016
    Co-Authors: Mieke Ten L G Eikelder, Marta Jozwiak, Katrien Oude Rengerink, Marielle G Van Pampus, Jan Willem De Leeuw, Irene M De Graaf, Marloes Holswilder, Martijn A Oudijk, Gert Jan Van Baaren, Paula J M Pernet
    Abstract:

    When pregnancy complications pose a threat to the mother or fetus or both, induction of labor is often required. Induction of labor is accomplished through a variety of methods; in pregnant women having an unfavourable cervix, cervical ripening of the cervix is accomplished through various mechanical and pharmacological means. Oral misoprostol and Foley catheter are believed to be equally effective in women with an unfavorable cervix in accomplishing vaginal birth. The current open-label randomized noninferiority trial was conducted in pregnant women with a singleton gestation in 29 hospitals in the Netherlands (2012 to 2013) to directly compare oral misoprostol with Foley catheter. Women with a viable singleton pregnancy in cephalic presentation, intact membranes, gestational age of 37 weeks or more, and an unfavorable cervix were included in the trial. The women were then randomly allocated (1:1) to oral misoprostol (n = 932) or Foley catheter (n = 927). Oral misoprostol dosage given was 50 µg orally once every 4 hours with a maximum of 3 times a day. Placement of a 30-mL Foley catheter in the cervix was done either digitally or using a vaginal speculum. The results of the study showed that the primary outcome (asphyxia or postpartum hemorrhage) occurred in 12.2% women in the misoprostol group and in 11.5% women in the Foley catheter group (adjusted relative risk [RR], 1.06; 90% confidence interval [CI], 0.86–1.31). Cesarean delivery resulted in 16.8% of labors in the misoprostol group and in 20.1% of the time in the Foley catheter group (no significant difference between groups [RR, 0.84; 95% CI, 0.69–1.01]). When the indication for cesarean delivery was examined, fewer cesarean deliveries for failure to progress in the first stage occurred after induction in the misoprostol group than in the Foley catheter group (6.2% vs 10.6%; RR, 0.58; 95% CI, 0.42–0.79). In addition, operative vaginal delivery occurred more frequently in the misoprostol group. Among the misoprostol group spontaneous membrane rupture was more common and labor augmentation with oxytocin was less likely. The study leads to a conclusion that in terms of safety and effectiveness, induction of labour using oral misoprostol is as safe as mechanical induction using Foley catheter.

  • women s experiences with and preference for induction of labor with oral misoprostol or Foley catheter at term
    American Journal of Perinatology, 2016
    Co-Authors: Mieke Ten L G Eikelder, Marta Jozwiak, Katrien Oude Rengerink, Marieke M Van De Meent, Kelly Mast, Irene De Graaf, Marloes Holswilderolde A G Scholtenhuis, Frans J M E Roumen, Martina Porath, Aren J Van Loon
    Abstract:

    Objective We assessed experience and preferences among term women undergoing induction of labor with oral misoprostol or Foley catheter. Study Design In 18 of the 29 participating hospitals in the PROBAAT-II trial, women were asked to complete a questionnaire within 24 hours after delivery. We adapted a validated questionnaire about expectancy and experience of labor and asked women whether they would prefer the same method again in a future pregnancy. Results The questionnaire was completed by 502 (72%) of 695 eligible women; 273 (54%) had been randomly allocated to oral misoprostol and 229 (46%) to Foley catheter. Experience of the duration of labor, pain during labor, general satisfaction with labor, and feelings of control and fear related to their expectation were comparable between both the groups. In the oral misoprostol group, 6% of the women would prefer the other method if induction is necessary in future pregnancy, versus 12% in the Foley catheter group (risk ratio: 0.70; 95% confidence interval: 0.55-0.90; p = 0.02). Conclusion Women's experiences of labor after induction with oral misoprostol or Foley catheter are comparable. However, women in the Foley catheter group prefer more often to choose a different method for future inductions.

  • induction of labour at term with oral misoprostol versus a Foley catheter probaat ii a multicentre randomised controlled non inferiority trial
    The Lancet, 2016
    Co-Authors: Mieke Ten L G Eikelder, Marta Jozwiak, Katrien Oude Rengerink, Marielle G Van Pampus, Jan Willem De Leeuw, Irene M De Graaf, Marloes Holswilder, Martijn A Oudijk, Gert Jan Van Baaren, Paula J M Pernet
    Abstract:

    Summary Background Labour is induced in 20–30% of all pregnancies. In women with an unfavourable cervix, both oral misoprostol and Foley catheter are equally effective compared with dinoprostone in establishing vaginal birth, but each has a better safety profile. We did a trial to directly compare oral misoprostol with Foley catheter alone. Methods We did an open-label randomised non-inferiority trial in 29 hospitals in the Netherlands. Women with a term singleton pregnancy in cephalic presentation, an unfavourable cervix, intact membranes, and without a previous caesarean section who were scheduled for induction of labour were randomly allocated to cervical ripening with 50 μg oral misoprostol once every 4 h or to a 30 mL transcervical Foley catheter. The primary outcome was a composite of asphyxia (pH ≤7·05 or 5-min Apgar score Findings Between July, 2012, and October, 2013, we randomly assigned 932 women to oral misoprostol and 927 women to Foley catheter. The composite primary outcome occurred in 113 (12·2%) of 924 participants in the misoprostol group versus 106 (11·5%) of 921 in the Foley catheter group (adjusted relative risk 1·06, 90% CI 0·86–1·31). Caesarean section occurred in 155 (16·8%) women versus 185 (20·1%; relative risk 0·84, 95% CI 0·69–1·02, p=0·067). 27 adverse events were reported in the misoprostol group versus 25 in the Foley catheter group. None were directly related to the study procedure. Interpretation In women with an unfavourable cervix at term, induction of labour with oral misoprostol and Foley catheter has similar safety and effectiveness. Funding FondsNutsOhra.

  • Foley catheter versus vaginal misoprostol randomized controlled trial probaat m study and systematic review and meta analysis of literature
    American Journal of Perinatology, 2013
    Co-Authors: Marta Jozwiak, Mieke Ten L G Eikelder, Katrien Oude Rengerink, Christianne J M De Groot, Hanneke Feitsma, Marc E A Spaanderman, Marielle G Van Pampus, Jan Willem De Leeuw, Ben Willem J Mol, Kitty W M Bloemenkamp
    Abstract:

    Objectives To assess effectiveness and safety of Foley catheter versus vaginal misoprostol for term induction of labor. Study Design This trial randomly allocated women with singleton term pregnancy to 30-mL Foley catheter or 25-μg vaginal misoprostol tablets. Primary outcome was cesarean delivery rate. Secondary outcomes were maternal and neonatal morbidity and time to birth. Additionally, a systematic review was conducted. Results Fifty-six women were allocated to Foley catheter, 64 to vaginal misoprostol tablets. Cesarean delivery rates did not differ significantly (25% Foley versus 17% misoprostol; relative risk [RR] 1.46, 95% confidence interval [CI] 0.72 to 2.94), with more cesarean deliveries due to failure to progress in the Foley group (14% versus 3%; RR 4.57, 95% CI 1.01 to 20.64). Maternal and neonatal outcomes were comparable. Time from induction to birth was longer in the Foley catheter group (36 hours versus 25 hours; p  Conclusion Our trial and meta-analysis showed no difference in cesarean delivery rates and less hyperstimulation with fetal heart rate changes and vaginal instrumental deliveries when using Foley catheter, thereby supporting potential advantages of the Foley catheter over misoprostol as ripening agent.

Katrien Oude Rengerink - One of the best experts on this subject based on the ideXlab platform.

  • induction of labour at term with oral misoprostol versus a Foley catheter probaat ii a multicentre randomised controlled non inferiority trial
    Obstetrical & Gynecological Survey, 2016
    Co-Authors: Mieke Ten L G Eikelder, Marta Jozwiak, Katrien Oude Rengerink, Marielle G Van Pampus, Jan Willem De Leeuw, Irene M De Graaf, Marloes Holswilder, Martijn A Oudijk, Gert Jan Van Baaren, Paula J M Pernet
    Abstract:

    When pregnancy complications pose a threat to the mother or fetus or both, induction of labor is often required. Induction of labor is accomplished through a variety of methods; in pregnant women having an unfavourable cervix, cervical ripening of the cervix is accomplished through various mechanical and pharmacological means. Oral misoprostol and Foley catheter are believed to be equally effective in women with an unfavorable cervix in accomplishing vaginal birth. The current open-label randomized noninferiority trial was conducted in pregnant women with a singleton gestation in 29 hospitals in the Netherlands (2012 to 2013) to directly compare oral misoprostol with Foley catheter. Women with a viable singleton pregnancy in cephalic presentation, intact membranes, gestational age of 37 weeks or more, and an unfavorable cervix were included in the trial. The women were then randomly allocated (1:1) to oral misoprostol (n = 932) or Foley catheter (n = 927). Oral misoprostol dosage given was 50 µg orally once every 4 hours with a maximum of 3 times a day. Placement of a 30-mL Foley catheter in the cervix was done either digitally or using a vaginal speculum. The results of the study showed that the primary outcome (asphyxia or postpartum hemorrhage) occurred in 12.2% women in the misoprostol group and in 11.5% women in the Foley catheter group (adjusted relative risk [RR], 1.06; 90% confidence interval [CI], 0.86–1.31). Cesarean delivery resulted in 16.8% of labors in the misoprostol group and in 20.1% of the time in the Foley catheter group (no significant difference between groups [RR, 0.84; 95% CI, 0.69–1.01]). When the indication for cesarean delivery was examined, fewer cesarean deliveries for failure to progress in the first stage occurred after induction in the misoprostol group than in the Foley catheter group (6.2% vs 10.6%; RR, 0.58; 95% CI, 0.42–0.79). In addition, operative vaginal delivery occurred more frequently in the misoprostol group. Among the misoprostol group spontaneous membrane rupture was more common and labor augmentation with oxytocin was less likely. The study leads to a conclusion that in terms of safety and effectiveness, induction of labour using oral misoprostol is as safe as mechanical induction using Foley catheter.

  • women s experiences with and preference for induction of labor with oral misoprostol or Foley catheter at term
    American Journal of Perinatology, 2016
    Co-Authors: Mieke Ten L G Eikelder, Marta Jozwiak, Katrien Oude Rengerink, Marieke M Van De Meent, Kelly Mast, Irene De Graaf, Marloes Holswilderolde A G Scholtenhuis, Frans J M E Roumen, Martina Porath, Aren J Van Loon
    Abstract:

    Objective We assessed experience and preferences among term women undergoing induction of labor with oral misoprostol or Foley catheter. Study Design In 18 of the 29 participating hospitals in the PROBAAT-II trial, women were asked to complete a questionnaire within 24 hours after delivery. We adapted a validated questionnaire about expectancy and experience of labor and asked women whether they would prefer the same method again in a future pregnancy. Results The questionnaire was completed by 502 (72%) of 695 eligible women; 273 (54%) had been randomly allocated to oral misoprostol and 229 (46%) to Foley catheter. Experience of the duration of labor, pain during labor, general satisfaction with labor, and feelings of control and fear related to their expectation were comparable between both the groups. In the oral misoprostol group, 6% of the women would prefer the other method if induction is necessary in future pregnancy, versus 12% in the Foley catheter group (risk ratio: 0.70; 95% confidence interval: 0.55-0.90; p = 0.02). Conclusion Women's experiences of labor after induction with oral misoprostol or Foley catheter are comparable. However, women in the Foley catheter group prefer more often to choose a different method for future inductions.

  • induction of labour at term with oral misoprostol versus a Foley catheter probaat ii a multicentre randomised controlled non inferiority trial
    The Lancet, 2016
    Co-Authors: Mieke Ten L G Eikelder, Marta Jozwiak, Katrien Oude Rengerink, Marielle G Van Pampus, Jan Willem De Leeuw, Irene M De Graaf, Marloes Holswilder, Martijn A Oudijk, Gert Jan Van Baaren, Paula J M Pernet
    Abstract:

    Summary Background Labour is induced in 20–30% of all pregnancies. In women with an unfavourable cervix, both oral misoprostol and Foley catheter are equally effective compared with dinoprostone in establishing vaginal birth, but each has a better safety profile. We did a trial to directly compare oral misoprostol with Foley catheter alone. Methods We did an open-label randomised non-inferiority trial in 29 hospitals in the Netherlands. Women with a term singleton pregnancy in cephalic presentation, an unfavourable cervix, intact membranes, and without a previous caesarean section who were scheduled for induction of labour were randomly allocated to cervical ripening with 50 μg oral misoprostol once every 4 h or to a 30 mL transcervical Foley catheter. The primary outcome was a composite of asphyxia (pH ≤7·05 or 5-min Apgar score Findings Between July, 2012, and October, 2013, we randomly assigned 932 women to oral misoprostol and 927 women to Foley catheter. The composite primary outcome occurred in 113 (12·2%) of 924 participants in the misoprostol group versus 106 (11·5%) of 921 in the Foley catheter group (adjusted relative risk 1·06, 90% CI 0·86–1·31). Caesarean section occurred in 155 (16·8%) women versus 185 (20·1%; relative risk 0·84, 95% CI 0·69–1·02, p=0·067). 27 adverse events were reported in the misoprostol group versus 25 in the Foley catheter group. None were directly related to the study procedure. Interpretation In women with an unfavourable cervix at term, induction of labour with oral misoprostol and Foley catheter has similar safety and effectiveness. Funding FondsNutsOhra.

  • Foley catheter or prostaglandin e2 inserts for induction of labour at term an open label randomized controlled trial probaat p trial and systematic review of literature
    European Journal of Obstetrics & Gynecology and Reproductive Biology, 2013
    Co-Authors: M Jozwiak, Mieke Ten L G Eikelder, Katrien Oude Rengerink, Marielle G Van Pampus, Marja G K Dijksterhuis, Irene De Graaf, Joris A M Van Der Post, Paulien C M Van Der Salm, Hubertina C J Scheepers, N Schuitemaker
    Abstract:

    Abstract Objective To assess the safety and effectiveness of a transcervical Foley catheter compared to vaginal prostaglandin E2 inserts for term induction of labour. Study design We conducted an open-label randomized controlled trial in five hospitals in the Netherlands. Women with a singleton term pregnancy in cephalic presentation, intact membranes, unfavourable cervix, and no prior caesarean section were enrolled. Participants were randomly allocated by a web-based randomization system to induction of labour with a 30 ml Foley catheter or 10 mg slow-release vaginal prostaglandin E2 inserts in a 1:1 ratio. Due to the nature of the intervention this study was not blinded. The primary outcome was the caesarean section rate. Secondary outcomes were maternal and neonatal morbidity and time from intervention to birth. Additionally, we carried out a systematic review and meta-analysis of similar studies. Results We analyzed 226 women: 107 received a Foley catheter and 119 inserts. Caesarean section rates were comparable (20% versus 22%, RR 0.90, 95% CI 0.54–1.50). Secondary outcomes showed no differences. We observed no serious maternal or neonatal morbidity. Meta-analysis showed comparable caesarean section rates, but significantly fewer cases of hyperstimulation during the ripening phase when a Foley catheter was used. Conclusions We found, in this relatively small study, no differences in effectiveness and safety of induction of labour with a Foley catheter and 10 mg slow release vaginal prostaglandin E2 inserts. Meta-analysis confirmed a comparable caesarean section rate, and showed fewer cases of hyperstimulation when a Foley catheter was used.

  • Foley catheter versus vaginal misoprostol randomized controlled trial probaat m study and systematic review and meta analysis of literature
    American Journal of Perinatology, 2013
    Co-Authors: Marta Jozwiak, Mieke Ten L G Eikelder, Katrien Oude Rengerink, Christianne J M De Groot, Hanneke Feitsma, Marc E A Spaanderman, Marielle G Van Pampus, Jan Willem De Leeuw, Ben Willem J Mol, Kitty W M Bloemenkamp
    Abstract:

    Objectives To assess effectiveness and safety of Foley catheter versus vaginal misoprostol for term induction of labor. Study Design This trial randomly allocated women with singleton term pregnancy to 30-mL Foley catheter or 25-μg vaginal misoprostol tablets. Primary outcome was cesarean delivery rate. Secondary outcomes were maternal and neonatal morbidity and time to birth. Additionally, a systematic review was conducted. Results Fifty-six women were allocated to Foley catheter, 64 to vaginal misoprostol tablets. Cesarean delivery rates did not differ significantly (25% Foley versus 17% misoprostol; relative risk [RR] 1.46, 95% confidence interval [CI] 0.72 to 2.94), with more cesarean deliveries due to failure to progress in the Foley group (14% versus 3%; RR 4.57, 95% CI 1.01 to 20.64). Maternal and neonatal outcomes were comparable. Time from induction to birth was longer in the Foley catheter group (36 hours versus 25 hours; p  Conclusion Our trial and meta-analysis showed no difference in cesarean delivery rates and less hyperstimulation with fetal heart rate changes and vaginal instrumental deliveries when using Foley catheter, thereby supporting potential advantages of the Foley catheter over misoprostol as ripening agent.

Pierfrancesco Bolis - One of the best experts on this subject based on the ideXlab platform.

  • is transcervical Foley catheter actually slower than prostaglandins in ripening the cervix a randomized study
    American Journal of Obstetrics and Gynecology, 2011
    Co-Authors: Antonella Cromi, Fabio Ghezzi, Massimo Agosti, Maurizio Serati, Stefano Uccella, Veronica Arlant, Pierfrancesco Bolis
    Abstract:

    Objective The purpose of this study was to determine whether the maximum time for cervical ripening (from 24-12 hours) would influence the efficacy of a transcervical Foley catheter and to compare efficacy to that of a prostaglandin E 2 vaginal insert. Study Design Three hundred ninety-seven women were assigned randomly to (1) Foley catheter left in place for a maximum of 24 hours, (2) Foley catheter left in place for a maximum of 12 hours, or (3) prostaglandin E 2 controlled-release vaginal insert. Primary outcome was vaginal delivery within 24 hours. Results There were no differences in vaginal delivery rates. The proportion of women who achieved vaginal delivery in 24 hours was lower in the 24-hour Foley catheter group than in the other 2 groups (24-hour Foley catheter, 21.0%; 12-hour Foley catheter, 59.8%; vaginal prostaglandin E 2 , 48.5%; P Conclusion Cutting the ripening time with a Foley catheter by one-half increases the proportion of women who deliver vaginally within 24 hours and yields efficacy similar to that of prostaglandin E 2 vaginal insert.

  • is transcervical Foley catheter actually slower than prostaglandins in ripening the cervix a randomized study
    American Journal of Obstetrics and Gynecology, 2011
    Co-Authors: Antonella Cromi, Fabio Ghezzi, Massimo Agosti, Maurizio Serati, Stefano Uccella, Veronica Arlant, Pierfrancesco Bolis
    Abstract:

    Objective The purpose of this study was to determine whether the maximum time for cervical ripening (from 24-12 hours) would influence the efficacy of a transcervical Foley catheter and to compare efficacy to that of a prostaglandin E 2 vaginal insert. Study Design Three hundred ninety-seven women were assigned randomly to (1) Foley catheter left in place for a maximum of 24 hours, (2) Foley catheter left in place for a maximum of 12 hours, or (3) prostaglandin E 2 controlled-release vaginal insert. Primary outcome was vaginal delivery within 24 hours. Results There were no differences in vaginal delivery rates. The proportion of women who achieved vaginal delivery in 24 hours was lower in the 24-hour Foley catheter group than in the other 2 groups (24-hour Foley catheter, 21.0%; 12-hour Foley catheter, 59.8%; vaginal prostaglandin E 2 , 48.5%; P Conclusion Cutting the ripening time with a Foley catheter by one-half increases the proportion of women who deliver vaginally within 24 hours and yields efficacy similar to that of prostaglandin E 2 vaginal insert.

  • Cervical ripening with the Foley catheter.
    International Journal of Gynecology & Obstetrics, 2007
    Co-Authors: Antonella Cromi, Fabio Ghezzi, Stefano Uccella, S. Tomera, B Lischetti, Pierfrancesco Bolis
    Abstract:

    Abstract Objective: To evaluate maternal and neonatal outcomes in a large series of patients undergoing cervical ripening with a Foley catheter. Methods: The database of the Labor and Delivery Unit of the University of a teaching hospital in Italy was used to identify consecutive patients with a Bishop score (BS) of 4 or less who underwent pre-induction cervical ripening with a Foley catheter. The main outcome measures were clinical chorioamnionitis, endometritis, and suspected and culture-proven neonatal sepsis. Results: Of 602 women undergoing cervical ripening with a Foley catheter, 160 (26.6%) went into active labor without additional interventions. Oxytocin was administered immediately after removal of the Foley catheter in 188 (31.2%) of the women, and 254 (42.2%) required an application of prostaglandin E2 vaginal gel. The cesarean delivery rate was 25.6%. The median time to delivery was 1469 min (range, 94–3350 min). Of the women who gave birth vaginally, 225 (50.2%) were delivered within 24 h. Clinical chorioamnionitis and postpartum endometritis occurred in 3 (0.5%) and 6 (1.0%) of the women, respectively. Neonatal sepsis was suspected in 4 (0.7%) of the newborns but blood culture results were negative in all cases. Conclusion: Transcervical use of the Foley catheter is safe for pre-induction cervical ripening, and the associated risk of maternal or perinatal infections is negligible.