Investigating early labor induction for women with ruptured membranes at term
Comparison Between Two Protocols for Management of Prelabor Rupture of the Membranes at Term
This study is trying to see if starting labor early with oxytocin helps women with ruptured membranes at term have safer deliveries compared to waiting to see if labor starts on its own.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 524 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Rambam Health Care Campus Academic / other |
| Locations | 1 site (Ramat Yishai) |
| Trial ID | NCT04307069 on ClinicalTrials.gov |
What this trial studies
This study examines the effectiveness of early labor induction using oxytocin in women with prelabor rupture of membranes (PROM) at term compared to expectant management for up to 24 hours. The goal is to determine if early intervention can reduce the risk of maternal and neonatal complications associated with prolonged rupture of membranes. The study will include primiparous women with singleton pregnancies who meet specific eligibility criteria, and it will assess outcomes such as time to delivery and rates of adverse events. The findings could provide valuable insights into optimal management strategies for PROM at term.
Who should consider this trial
Good fit: Ideal candidates for this study are primiparous women with a singleton pregnancy who are at least 37 weeks gestation and have experienced prelabor rupture of membranes.
Not a fit: Patients who are under 18 years old, have multiple gestations, or present with contraindications for vaginal delivery will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved maternal and neonatal outcomes by reducing the risks associated with prolonged rupture of membranes.
How similar studies have performed: Previous studies have indicated that early intervention in cases of PROM may reduce adverse outcomes, suggesting that this approach has potential based on existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Primiparous women with a singleton pregnancy that are admitted with prelabor rupture of membranes. 2. Women at gestational age 370/7 or more. 3. Vertex presentation. Exclusion Criteria: 1. Age 18 and under. 2. High order gestation. 3. Women with contraindication for a vaginal delivery. 4. Active labor. 5. Documented fetal anomalies. 6. Known or suspected intrauterine infection (temperature \> 38 degrees, leucocytosis). 7. Non reassuring fetal heart rate tracing. 8. Positive group B streptococcus status.
Where this trial is running
Ramat Yishai
- Rambam — Ramat Yishai, Israel (Recruiting)
Study contacts
- Principal investigator: Gal Bachar, MD — Rambam Medical Health Center
- Study coordinator: Gal Bachar, MD
- Email: gal.bachar13@gmail.com
- Phone: +972524858699
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.