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

Prelabor Rupture of Membranes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05333731
• Other study ID #: JPPTOLAC-02
• Status: Recruiting
• Start date: March 30, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2022
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Jiang Ziyan, Ph.D
• Phone: 13512534017
• Email: zyjiangchm[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 528
• Est. completion date: June 30, 2025
• Est. primary completion date: December 30, 2024
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Failed Induction (of Labor) by Oxytocin
• Fetal Membranes, Premature Rupture
• Prelabor Rupture of Membranes
• Rupture

Intervention

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

Locations

Country	Name	City	State
China	First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (4)

Bellussi F, Livi A, Diglio J, Lenzi J, Magnani L, Pilu G. Timing of induction for term prelabor rupture of membranes and intravenous antibiotics. Am J Obstet Gynecol MFM. 2021 Jan;3(1):100245. doi: 10.1016/j.ajogmf.2020.100245. Epub 2020 Oct 6. — View Citation

Fishel Bartal M, Sibai BM, Ilan H, Fried M, Rahav R, Alexandroni H, Schushan Eisan I, Hendler I. Trial of labor after cesarean (TOLAC) in women with premature rupture of membranes(). J Matern Fetal Neonatal Med. 2020 Sep;33(17):2976-2982. doi: 10.1080/14767058.2019.1566312. Epub 2019 Jan 17. — View Citation

Middleton P, Shepherd E, Flenady V, McBain RD, Crowther CA. Planned early birth versus expectant management (waiting) for prelabour rupture of membranes at term (37 weeks or more). Cochrane Database Syst Rev. 2017 Jan 4;1:CD005302. doi: 10.1002/14651858.CD005302.pub3. Review. — View Citation

Prelabor Rupture of Membranes: ACOG Practice Bulletin, Number 217. Obstet Gynecol. 2020 Mar;135(3):e80-e97. doi: 10.1097/AOG.0000000000003700. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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