Inducing labor with oxytocin in pregnant women with ruptured membranes
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
This study is testing if using oxytocin to induce labor is safe and effective for pregnant women with ruptured membranes, including those who have had a previous cesarean section and want to try for a vaginal delivery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 528 (estimated) |
| Ages | 20 Years to 40 Years |
| Sex | Female |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT05333731 on ClinicalTrials.gov |
What this trial studies
This observational clinical trial aims to enroll 528 full-term pregnant women with prelabor rupture of membranes (PROM) to assess the outcomes of labor induction using oxytocin. Participants will be divided into two groups: those who have had a cesarean section and wish to attempt a trial of labor after cesarean (TOLAC), and those without contraindications for vaginal delivery. The study will monitor the delivery mode after 24 hours of induction and track postpartum complications and neonatal outcomes over 42 days. The trial follows the 2016 China VBAC clinical management guidelines.
Who should consider this trial
Good fit: Ideal candidates are full-term pregnant women aged 20-40 with singleton pregnancies and prelabor rupture of membranes who do not have contraindications to vaginal delivery.
Not a fit: Patients with known contraindications to vaginal delivery, multiple gestations, or severe complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the safety and efficacy of oxytocin induction in women with PROM, potentially improving delivery outcomes.
How similar studies have performed: Other studies have explored labor induction methods, but this specific approach focusing on PROM and TOLAC is less common, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Volunteers sign the informed consent; 2. Age: 20-40 years; 3. Singleton, a cephalic presentation; 4. No contradiction to vaginal delivery; 5. gestation: 37\~42 weeks; 6. With prelabor rupture of membrane. Exclusion criteria: 1. Konwn contraindication to vaginal delivery or severe complications; 2. Multiple gestation; 3. Uterine malformation; 4. Severe psychiatric disorder; 5. Without family's support.
Where this trial is running
Nanjing, Jiangsu
- First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Jiang Ziyan, Ph.D
- Email: zyjiangchm@163.com
- Phone: 13512534017
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.