Oxytocin/Foley vs. Oxytocin for Induction in Patients With PPROM

Официальное название

Combination Oxytocin/Foley Versus Oxytocin Alone for Induction of Labor in Patients With Preterm Prelabor Rupture of Membranes

Обзор

Data on the optimal mode of labor induction after preterm prelabor rupture of membranes (PPROM) is lacking. Studies have shown no difference between oxytocin and misoprostol use for labor induction in this cohort (1). The preponderance of evidence from term pregnancies suggests that Foley catheter coupled with oxytocin is better than oxytocin alone, with a higher rate of delivery within 24 hours when a Foley catheter followed by oxytocin is compared to oxytocin alone. However, the use of a Foley catheter has not been evaluated in prospective studies on patients with PPROM.

Вмешательства

• Комбинированный продукт Oxytocin plus Foley Catheter
  Intravenous oxytocin and a transcervical Foley catheter
• Препарат Oxytocin
  Intravenous oxytocin

Первичные конечные точки

• Vaginal Delivery within 12 Hours [Срок оценки: 12 hours]

Вторичные конечные точки (12)

• Vaginal Delivery Rate [Срок оценки: From enrollment until delivery]
• Intraamniotic Infection [Срок оценки: Enrollment through 6 weeks postpartum]
• Operative vaginal delivery [Срок оценки: From enrollment until delivery]
• Cesarean delivery [Срок оценки: From enrollment until delivery]
• Estimated and quantitative blood loss [Срок оценки: From enrollment until hospital discharge (up to 5 days post-delivery).]
• Blood transfusion [Срок оценки: From enrollment until hospital discharge (up to 5 days post-delivery)]
• Maternal morbidity and adverse maternal outcomes [Срок оценки: From enrollment until 6 weeks postpartum]
• Antepartum, intrapartum, or neonatal death [Срок оценки: From enrollment until 6 weeks postpartum]
• Suspected and confirmed neonatal sepsis [Срок оценки: From delivery until hospital discharge (up to 5 days post-delivery)]
• Birth weight [Срок оценки: Recorded day of delivery]
• Hypoglycemia (glucose < 35 mg/dl) requiring IV glucose therapy [Срок оценки: From birth until hospital discharge (up to 5 days post-delivery)]
• Intubation, continuous positive airway pressure (CPAP) or high-flow nasal cannula (HFNC) for ventilation or cardiopulmonary resuscitation within first 72 hours [Срок оценки: From birth until 72 hours after delivery]

Критерии участия

Критерии включения

• Patients 18-50 years of age;
• The patient is fluent in English, physically and mentally able to understand the informed consent, and is willing to participate in this study;
• PPROM;
• Cervical dilation </= 2cm
• Fetal cephalic presentation;
• The patient is between 34 weeks 0 days and 36 weeks 6 days of gestation at the time of enrollment. Gestational age will be determined by last menstrual period, confirmed with a first trimester ultrasound, per the recommended guidelines by the American College of Obstetricians and Gynecologists.

Критерии исключения

• Spontaneous labor
• Known allergy to latex;
• Cervical dilation >2cm;
• Chorioamnionitis;
• Contraindications to induction of labor or use of Foley for cervical ripening
• HIV
• Known or suspected fetal anomaly or aneuploidy;
• Prisoners.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Sentara Norfolk General Hospital — Norfolk

Публикации

• McMaster K, Sanchez-Ramos L, Kaunitz AM. Evaluation of a Transcervical Foley Catheter as a Source of Infection: A Systematic Review and Meta-analysis. Obstet Gynecol. 2015 Sep;126(3):539-551. doi: 10.1097/AOG.0000000000001002. PMID 26244535
• Gomez Slagle HB, Hoffman MK, Sciscione AC, Ma'ayeh M. Combination Foley Catheter-Oxytocin versus Oxytocin Alone following Preterm Premature Rupture of Membranes. Am J Perinatol. 2024 May;41(S 01):e3030-e3034. doi: 10.1055/a-2185-4102. Epub 2023 Oct 4. PMID 37793430
• Amorosa JMH, Stone J, Factor SH, Booker W, Newland M, Bianco A. A randomized trial of Foley Bulb for Labor Induction in Premature Rupture of Membranes in Nulliparas (FLIP). Am J Obstet Gynecol. 2017 Sep;217(3):360.e1-360.e7. doi: 10.1016/j.ajog.2017.04.038. Epub 2017 May 4. PMID 28479288
• Mackeen AD, Durie DE, Lin M, Huls CK, Qureshey E, Paglia MJ, Sun H, Sciscione A. Foley Plus Oxytocin Compared With Oxytocin for Induction After Membrane Rupture: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jan;131(1):4-11. doi: 10.1097/AOG.0000000000002374. PMID 29215519
• Levine LD, Downes KL, Elovitz MA, Parry S, Sammel MD, Srinivas SK. Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1357-1364. doi: 10.1097/AOG.0000000000001778. PMID 27824758
• Schoen CN, Grant G, Berghella V, Hoffman MK, Sciscione A. Intracervical Foley Catheter With and Without Oxytocin for Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2017 Jun;129(6):1046-1053. doi: 10.1097/AOG.0000000000002032. PMID 28486381
• Lin MG, Nuthalapaty FS, Carver AR, Case AS, Ramsey PS. Misoprostol for labor induction in women with term premature rupture of membranes: a meta-analysis. Obstet Gynecol. 2005 Sep;106(3):593-601. doi: 10.1097/01.AOG.0000172425.56840.57. PMID 16135593

Идентификаторы

NCT: NCT07119398 · 24-04-FB-0086

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗