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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05333731
Other study ID # JPPTOLAC-02
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


Related Conditions & MeSH terms


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
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