Oxytocin Induction in Full Term Pregnant Women With Cesarean Section of Prelabor Rupture of Membranes

Study Overview
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Brief Summary
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This study is a multi-center, prospective, observational clinical trial study. 528 full-term pregnant women will be enrolled as subjects, and the ratio of eligible subjects in the two groups is 1:1. In the cesarean section group, full term pregnant women with prelabor rupture of membrane (PROM) who are willing to try the trial of labor after cesarean (TOLAC) and in accordance with the criteria according to the 2016 China vaginal birth after cesarean (VBAC) clinical management guidelines will be enrolled and recorded by our homemade registration form of TOLAC. In the non-cesarean section group, pregnant women after 37 weeks of gestation with PROM but without vaginal labor contraindications will be enrolled. Whether in the cesarean section group or non-cesarean section group, if spontaneous labor does not occur, and they all will be induced by oxytocin. After 24 hours, their final delivery mode will be recorded. In the following 42 days postpartum, their complications and the neonatal outcome will be followed up.

Official Title
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To Study the Effectiveness and Safety of Oxytocin Induction in Full Term Pregnant Women With Cesarean Section of Prelabor Rupture of Membranes: a Multi-center, Prospective, Observational Study

Conditions
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Failed Trial of Labor, Unspecified, With Delivery, Failed VBAC (Vaginal Birth After Caesarean), Prelabor Rupture of Membranes, Failed Induction (of Labor) by Oxytocin

Intervention / Treatment
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* Drug: Oxytocin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Volunteers sign the informed consent; Age: 20-40 years; Singleton, a cephalic presentation; No contradiction to vaginal delivery; gestation: 37 42 weeks; With prelabor rupture of membrane. Exclusion criteria: Konwn contraindication to vaginal delivery or severe complications; Multiple gestation; Uterine malformation; Severe psychiatric disorder; Without family's support.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cesarean section group<br>In the cesarean section group, all the pregnant women had only one prior cesarean section. | Drug: Oxytocin<br>* In the two groups, if spontaneous labor does not occur after PROM, they all receive the oxytocin for up to 24h.<br>|
| Non-cesarean section group<br>In the non-cesarean section group, all the pregnant women are primipara, and never had a cesarean section. | Drug: Oxytocin<br>* In the two groups, if spontaneous labor does not occur after PROM, they all receive the oxytocin for up to 24h.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vignial birth rate | After the treatment of oxytocin induction for up tp 24 hours, the mode of delivery will be konwn and recorded. | 24 hours |