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

NCT05215041 | Unknown

• 1 other identifier: JPPTOLAC-03
• Study Type: observational
• Target: 510
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Trial of Labor After Cesarean; Vaginal Birth After Cesarean; Spontaneous Labor

Outcome Measures

Primary Outcomes (1)

• Vignial birth rate

  After spontaneous labor for up tp 24h, the mode of delivery will be konwn and recorded.

  24 hours

Study Arms (2)

Cesarean section group

Other: Non intervention

Non-cesarean section group

Other: Non intervention

Interventions

Non intervention OTHER

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

Cesarean section group; Non-cesarean section group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

In the cesarean section group, the extra inclusion criteria includes: Only one prior low transverse uterine incision;Extra exclusion criteria:1. With mutiple history of c esction;2. Prior extensive transfundal uterine surgery, such as for fetal surgery, myomectomy, or uterine reconstruction; Prior classical vertical uterine incision, or an inverted "T" or "J" incision;3. Short interpregnancy interval;4.Prior uterine rupture or dehiscence, or cesarean scar pregnancy;4.Evaluated fetal birth weight\> 4000 g. In the non-cesarean section group, the extra criteria should include: nulliparous

You may qualify if:

• Volunteers sign the informed consent
• Age: 20-40 years;
• Singleton, a cephalic presentation;
• No contradiction to vaginal delivery; 5.39\~42 weeks; 6.Spontaneous labor

You may not qualify if:

• Konwn contraindication to vaginal delivery or severe complications;
• Multiple gestation;
• Uterine malformation;
• Severe psychiatric disorder;
• Without family's support.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 29365328 BACKGROUND

• 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.

  PMID: 23307166 BACKGROUND

Study Officials

• Jiang Ziyan, Ph.D

  Department of Obstetrics and Gynecology, First Affiliated Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiang Ziyan, Ph.D

CONTACT

13512534017; zyjiangchm@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: January 31, 2022
• Study Start: January 28, 2022
• Primary Completion: December 30, 2024
• Study Completion: June 30, 2025
• Last Updated: April 25, 2022

Record last verified: 2022-04

Locations

CN (1)