The Effectiveness and Safety of the Trial of Labor in Full Term Pregnant Women With Cesarean Section After Spontaneous Labor

Vaginal Birth After Cesarean Clinical Trial

Official title:

To Study the Effectiveness and Safety of the Trail of Labor in Full Term Pregnant Women With Cesarean Section After Spontaneous Labor: a Multi-center, Prospective, Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05215041
• Other study ID #: JPPTOLAC-03
• Status: Recruiting
• Start date: January 28, 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. 510 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 one prior cesarean section after spontaneous labor 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 after spontaneous labor but without vaginal labor contraindications will be enrolled. After spontaneous labor for 24h, 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: 510
• Est. completion date: June 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: 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; 5.39~42 weeks; 6.Spontaneous labor

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

• Vaginal Birth After Cesarean

Intervention

Other:
• Non intervention
If the vaginal delivery is failed after spontaneous labor for up to 24h, they will receive cesarean section

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 (2)

Al-Shaikh G, Al-Mandeel H. The outcomes of trial of labour after cesarean section following induction of labour compared to spontaneous labour. Arch Gynecol Obstet. 2013 Jun;287(6):1099-103. doi: 10.1007/s00404-013-2709-z. Epub 2013 Jan 11. — View Citation

Lassey SC, Robinson JN, Kaimal AJ, Little SE. Outcomes of Spontaneous Labor in Women Undergoing Trial of Labor after Cesarean as Compared with Nulliparous Women: A Retrospective Cohort Study. Am J Perinatol. 2018 Jul;35(9):852-857. doi: 10.1055/s-0037-1619448. Epub 2018 Jan 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vignial birth rate	After spontaneous labor for up tp 24h, the mode of delivery will be konwn and recorded.	24 hours