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RecruitingNCT05215041Updated Apr 25, 2022

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

An observational study in Trial of Labor After Cesarean, Vaginal Birth After Cesarean and Spontaneous Labor, sponsored by The First Affiliated Hospital with Nanjing Medical University. Recruiting at 1 site in China. Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-25.

Sponsored by The First Affiliated Hospital with Nanjing Medical University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Jan 2022; still recruiting 4 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
510
Ages
20 Years to 40 Years
Sex
Female
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Study 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.

02

Conditions studied

  • Trial of Labor After Cesarean
  • Vaginal Birth After Cesarean
  • Spontaneous Labor
03

In context

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
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

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
510 participants (estimated)
Patient registry
No

Groups and cohorts

  • Cesarean section group

    Other: Non intervention

  • Non-cesarean section group

    Other: Non intervention

Interventions

  • OtherNon intervention

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

06

What researchers measure

Primary outcomes

  1. Vignial birth rate

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

    Time frame: 24 hours

07

Study locations

1 of 1 sites recruiting
  • First Affiliated Hospital of Nanjing Medical University
    Nanjing, Jiangsu, China
    • Tang Jinhai · Contact
    Recruiting
08

References and documents

Publications

  • 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. PubMed 29365328 ↗
  • 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. PubMed 23307166 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05215041
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Responsible party
Sponsor
First posted
Jan 31, 2022
Start date
Jan 28, 2022
Primary completion
Dec 30, 2024 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
Apr 25, 2022

Study contacts

Jiang Ziyan, Ph.D
Contact
zyjiangchm@163.com
13512534017
Jiang Ziyan, Ph.D
principal investigator · Department of Obstetrics and Gynecology, First Affiliated Hospital of Nanjing Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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