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

  • comparing induction of labour with oral misoprostol or Foley Catheter at term cost effectiveness analysis of a randomised controlled multi centre non inferiority trial
    British Journal of Obstetrics and Gynaecology, 2018
    Co-Authors: Mieke Ten L G Eikelder, Marta Jozwiak, Gj Van Baaren, Oude K Rengerink, J W De Leeuw, Gunilla Kleiverda, Inge M Evers, K De Boer, Jozien T J Brons, Kitty W M Bloemenkamp
    Abstract:

    Objective To assess the costs of labour induction with oral misoprostol compared to Foley Catheter. Design Economic evaluation alongside a randomised controlled trial. Setting Obstetric departments of six tertiary and 23 secondary care hospitals in the Netherlands. Population Women with a viable term singleton pregnancy in cephalic presentation, intact membranes, an unfavourable cervix (Bishop score <6) without a previous caesarean section, had been randomised for labour induction with oral misoprostol (n = 924) or Foley Catheter (n = 921). Methods We performed economic analysis from a hospital perspective. We estimated direct medical costs associated with healthcare utilisation from randomisation until discharge. The robustness of our findings was evaluated in sensitivity analyses. Main Outcome Measures Mean costs and differences were calculated per women induced with oral misoprostol or Foley Catheter. Results Mean costs per woman in the oral misoprostol group and in the Foley Catheter group were €4470 versus €4158, respectively (mean difference €312 (95% confidence interval (CI) -€508 to €1063)). Multiple sensitivity analyses did not change these conclusions. Only, when cervical ripening for low-risk pregnancies in the Foley Catheter group would be carried out in an outpatient setting, with admittance to labour ward only at start of active labour, the difference would be €4470 versus €3489, respectively (mean difference €981 (95% CI €225 to €1817)). Conclusions Oral misoprostol and Foley Catheter generate comparable costs. Cervical ripening outside labour ward with a Foley Catheter could potentially save almost €1,000 per woman. This article is protected by copyright. All rights reserved.

  • 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.

  • cervical ripening with Foley Catheter for induction of labor after cesarean section a cohort study
    Acta Obstetricia et Gynecologica Scandinavica, 2014
    Co-Authors: Marta Jozwiak, Marja G K Dijksterhuis, Hilde A Van De Lest, Nicole B Burger, Jan Willem De Leeuw
    Abstract:

    Objective To evaluate spontaneous vaginal delivery and complication rates after induction of labor with a transcervical Foley Catheter in women with a previous cesarean delivery. Design Retrospective cohort study. Setting Secondary teaching hospital in the second largest city of the Netherlands. Population Women with a history of cesarean delivery (n = 208), undergoing induction of labor with a Foley Catheter in a subsequent pregnancy. Material and methods The women who had induction of labor with a transcervical Foley Catheter in the Ikazia Hospital, Rotterdam, between January 2003 and January 2012, were identified in a computerized database. Patient's records were checked for accuracy. Main outcome measures Vaginal delivery rate, cesarean section rate, uterine rupture and maternal and neonatal (infectious) morbidity. Results Of the women 60% had a spontaneous vaginal delivery and 11% were delivered by vacuum extraction. Uterine rupture occurred in one woman. Postpartum hemorrhage was the most common maternal complication (12%). Maternal intrapartum and postpartum infections occurred in 5% and 1%. Proven neonatal infection was found in 3% of the cases. Two perinatal deaths occurred (1%), of which one was related to uterine rupture. Conclusion Induction of labor with a transcervical Foley Catheter is an effective method to achieve vaginal delivery in women with a previous cesarean delivery. There is a low risk of uterine rupture and maternal and neonatal (infectious) morbidity in this cohort.

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

  • comparing induction of labour with oral misoprostol or Foley Catheter at term cost effectiveness analysis of a randomised controlled multi centre non inferiority trial
    British Journal of Obstetrics and Gynaecology, 2018
    Co-Authors: Mieke Ten L G Eikelder, Marta Jozwiak, Gj Van Baaren, Oude K Rengerink, J W De Leeuw, Gunilla Kleiverda, Inge M Evers, K De Boer, Jozien T J Brons, Kitty W M Bloemenkamp
    Abstract:

    Objective To assess the costs of labour induction with oral misoprostol compared to Foley Catheter. Design Economic evaluation alongside a randomised controlled trial. Setting Obstetric departments of six tertiary and 23 secondary care hospitals in the Netherlands. Population Women with a viable term singleton pregnancy in cephalic presentation, intact membranes, an unfavourable cervix (Bishop score <6) without a previous caesarean section, had been randomised for labour induction with oral misoprostol (n = 924) or Foley Catheter (n = 921). Methods We performed economic analysis from a hospital perspective. We estimated direct medical costs associated with healthcare utilisation from randomisation until discharge. The robustness of our findings was evaluated in sensitivity analyses. Main Outcome Measures Mean costs and differences were calculated per women induced with oral misoprostol or Foley Catheter. Results Mean costs per woman in the oral misoprostol group and in the Foley Catheter group were €4470 versus €4158, respectively (mean difference €312 (95% confidence interval (CI) -€508 to €1063)). Multiple sensitivity analyses did not change these conclusions. Only, when cervical ripening for low-risk pregnancies in the Foley Catheter group would be carried out in an outpatient setting, with admittance to labour ward only at start of active labour, the difference would be €4470 versus €3489, respectively (mean difference €981 (95% CI €225 to €1817)). Conclusions Oral misoprostol and Foley Catheter generate comparable costs. Cervical ripening outside labour ward with a Foley Catheter could potentially save almost €1,000 per woman. This article is protected by copyright. All rights reserved.

  • 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: Marta Jozwiak, Mieke Ten L G Eikelder, Katrien Oude Rengerink, Marielle G Van Pampus, Marja G K Dijksterhuis, Irene De Graaf, Paulien C M Van Der Salm, Hubertina C J Scheepers, Joris A. M. Van Der Post, 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.

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: Marta Jozwiak, Mieke Ten L G Eikelder, Katrien Oude Rengerink, Marielle G Van Pampus, Marja G K Dijksterhuis, Irene De Graaf, Paulien C M Van Der Salm, Hubertina C J Scheepers, Joris A. M. Van Der Post, 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.

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

  • intracervical Foley Catheter with and without oxytocin for labor induction a randomized controlled trial
    Obstetrics & Gynecology, 2017
    Co-Authors: Corina N Schoen, Matthew K Hoffman, Gwendolyn Grant, Vincenzo Berghella, Anthony Sciscione
    Abstract:

    OBJECTIVE:To evaluate whether adding oxytocin to preinduction cervical ripening with a Foley Catheter increases the rate of delivery within 24 hours.METHODS:This was a randomized, multicenter, parallel trial of women with a singleton pregnancy at 24 weeks of gestation or greater undergoing labor ind

  • 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.

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  • 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.

  • 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.

  • cervical ripening with Foley Catheter for induction of labor after cesarean section a cohort study
    Acta Obstetricia et Gynecologica Scandinavica, 2014
    Co-Authors: Marta Jozwiak, Marja G K Dijksterhuis, Hilde A Van De Lest, Nicole B Burger, Jan Willem De Leeuw
    Abstract:

    Objective To evaluate spontaneous vaginal delivery and complication rates after induction of labor with a transcervical Foley Catheter in women with a previous cesarean delivery. Design Retrospective cohort study. Setting Secondary teaching hospital in the second largest city of the Netherlands. Population Women with a history of cesarean delivery (n = 208), undergoing induction of labor with a Foley Catheter in a subsequent pregnancy. Material and methods The women who had induction of labor with a transcervical Foley Catheter in the Ikazia Hospital, Rotterdam, between January 2003 and January 2012, were identified in a computerized database. Patient's records were checked for accuracy. Main outcome measures Vaginal delivery rate, cesarean section rate, uterine rupture and maternal and neonatal (infectious) morbidity. Results Of the women 60% had a spontaneous vaginal delivery and 11% were delivered by vacuum extraction. Uterine rupture occurred in one woman. Postpartum hemorrhage was the most common maternal complication (12%). Maternal intrapartum and postpartum infections occurred in 5% and 1%. Proven neonatal infection was found in 3% of the cases. Two perinatal deaths occurred (1%), of which one was related to uterine rupture. Conclusion Induction of labor with a transcervical Foley Catheter is an effective method to achieve vaginal delivery in women with a previous cesarean delivery. There is a low risk of uterine rupture and maternal and neonatal (infectious) morbidity in this cohort.

  • 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.