NCT07119398招募中4 期
Combination Oxytocin/Foley Versus Oxytocin Alone for Induction of Labor in Patients With Preterm Prelabor Rupture of Membranes
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Vaginal Delivery within 12 Hours
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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;
- •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.
排除标准
- •Spontaneous labor
- •Known allergy to latex;
- •Cervical dilation >2cm;
- •Chorioamnionitis;
- •Contraindications to induction of labor or use of Foley for cervical ripening
- •Known or suspected fetal anomaly or aneuploidy;
- •Prisoners.
研究组 & 干预措施
Oxytocin plus Foley
Experimental
• Induction of labor with intravenous oxytocin and a transcervical Foley catheter
干预措施: Oxytocin plus Foley Catheter (Combination Product)
Oxytocin Only
Active Comparator
• Induction of labor with intravenous oxytocin
干预措施: Oxytocin (Drug)
结局指标
主要结局
Vaginal Delivery within 12 Hours
时间窗: 12 hours
Vaginal Delivery within 12 hours of induction
次要结局
- Vaginal Delivery Rate(From enrollment until delivery)
- Intraamniotic Infection(Enrollment through 6 weeks postpartum)
- Operative vaginal delivery(From enrollment until delivery)
- Cesarean delivery(From enrollment until delivery)
- Estimated and quantitative blood loss(From enrollment until hospital discharge (up to 5 days post-delivery).)
- Blood transfusion(From enrollment until hospital discharge (up to 5 days post-delivery))
- Maternal morbidity and adverse maternal outcomes(From enrollment until 6 weeks postpartum)
- Antepartum, intrapartum, or neonatal death(From enrollment until 6 weeks postpartum)
- Suspected and confirmed neonatal sepsis(From delivery until hospital discharge (up to 5 days post-delivery))
- Birth weight(Recorded day of delivery)
- Hypoglycemia (glucose &lt; 35 mg/dl) requiring IV glucose therapy(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(From birth until 72 hours after delivery)
- Neonatal encephalopathy(From birth until hospital discharge (up to 5 days after delivery))
- Seizures(From birth until hospital discharge (up to 5 days post-delivery))
- Shoulder dystocia(Recorded day of delivery)
- Birth trauma(Recorded day of delivery)
- Intracranial hemorrhage(From birth until hospital discharge (up to 5 days post-delivery))
- Hyperbilirubinemia requiring phototherapy or exchange transfusion(From birth until hospital discharge (up to 5 days post-delivery))
- NICU admission(From birth until time of NICU admission or hospital discharge (up to 5 days post-delivery), whichever comes first)
研究者
Marwan Ma'ayeh
Assistant Professor
Eastern Virginia Medical School
研究点 (1)
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