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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05333731
Enrollment
528
Registered
2022-04-19
Start date
2022-03-30
Completion date
2025-06-30
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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.

Interventions

DRUGOxytocin

In the two groups, if spontaneous labor does not occur after PROM, they all receive the oxytocin for up to 24h.

Sponsors

The First Affiliated Hospital with Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Vignial birth rate24 hoursAfter the treatment of oxytocin induction for up tp 24 hours, the mode of delivery will be konwn and recorded.

Countries

China

Contacts

Primary ContactJiang Ziyan, Ph.D
zyjiangchm@163.com13512534017

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026