Balloon Catheter Combined With Oxytocin Induction Among the Pregnant Women With Previous Cesarean Section

NCT ID: NCT05246761

Last Updated: 2022-04-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 924 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-30
• Study Completion Date: 2024-12-30

Brief Summary

This study is a multi-center, prospective, observational clinical trial study. 924 full-term pregnant women will be enrolled as subjects, and the ratio of eligible subjects in the two groups is 1:1. In the prior cesarean section group, pregnant women with one previous cesarean section who are willing to try to 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 control group, pregnant women after 39 weeks of gestation without vaginal labor contraindications will be enrolled. Whether in the experimental group or the control group, their cervical bishop score was less than 6 points, and they all will be induced by balloon catheter + oxytocin. After 96h, 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; Bishop Score; Failed Mechanical Induction; Balloon Catheter for Labor Induction; Unfavorable Cervix

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cesarean section group

In the cesarean section group, all the pregnant women had only one prior cesarean section.

Balloon catheter

Intervention Type: DEVICE

In the two groups, if their bishop score \<6, they will receive the cervical riening by the balloon catheter, and then the oxytocin if necessary.

Non-cesarean section group

In the non-cesarean section group, all the pregnant women are primipara，and never had a cesarean section.

Balloon catheter

Intervention Type: DEVICE

In the two groups, if their bishop score \<6, they will receive the cervical riening by the balloon catheter, and then the oxytocin if necessary.

Interventions

Balloon catheter

In the two groups, if their bishop score \<6, they will receive the cervical riening by the balloon catheter, and then the oxytocin if necessary.

Intervention Type: DEVICE

Eligibility Criteria

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.

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

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiang Ziyan, Ph.D

Role: PRINCIPAL_INVESTIGATOR

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

Locations

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiang Ziyan, Ph.D

Role: CONTACT

zyjiangchm@163.com

13512534017

Facility Contacts

Tang Jinhai

Role: primary

References

Huisman CMA, Ten Eikelder MLG, Mast K, Oude Rengerink K, Jozwiak M, van Dunne F, Duvekot JJ, van Eyck J, Gaugler-Senden I, de Groot CJM, Franssen MTM, van Gemund N, Langenveld J, de Leeuw JW, Oude Lohuis EJ, Oudijk MA, Papatsonis D, van Pampus M, Porath M, Rombout-de Weerd S, van Roosmalen JJ, van der Salm PCM, Scheepers HCJ, Sikkema MJ, Sporken J, Stigter RH, van Wijngaarden WJ, Woiski M, Mol BWJ, Bloemenkamp KWM; PROBAAT-S project group. Balloon catheter for induction of labor in women with one previous cesarean and an unfavorable cervix. Acta Obstet Gynecol Scand. 2019 Jul;98(7):920-928. doi: 10.1111/aogs.13558. Epub 2019 Mar 7.

Reference Type: BACKGROUND

PMID: 30723900 (View on PubMed)

Battarbee AN, Palatnik A, Peress DA, Grobman WA. The Association between Cervical Exam after Ripening with Foley Balloon Catheter and Outcomes of Nulliparous Labor Induction. Am J Perinatol. 2018 Aug;35(10):1001-1005. doi: 10.1055/s-0038-1635091. Epub 2018 Feb 28.

Reference Type: BACKGROUND

PMID: 29490397 (View on PubMed)

Other Identifiers

JPPTOLAC-01

Identifier Type: -

Identifier Source: org_study_id