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

NCT ID: NCT05215041

Last Updated: 2022-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

510 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-28

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Trial of Labor After Cesarean Vaginal Birth After Cesarean Spontaneous Labor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cesarean section group

Non intervention

Intervention Type OTHER

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

Non-cesarean section group

Non intervention

Intervention Type OTHER

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

Interventions

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Non intervention

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jiang Ziyan, Ph.D

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiang Ziyan, Ph.D

Role: CONTACT

13512534017

Facility Contacts

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Tang Jinhai

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 29365328 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23307166 (View on PubMed)

Other Identifiers

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JPPTOLAC-03

Identifier Type: -

Identifier Source: org_study_id

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