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

NCT05246761 | Unknown

• 1 other identifier: JPPTOLAC-01
• Study Type: observational
• Target: 924
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• vignial birth rate

  After the treatment of balloon catheter for 12 hours +oxytocin induction for up tp 72 hours, the mode of delivery will be konwn and recorded.

  up to 84 hours

Study Arms (2)

Cesarean section group

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

Device: Balloon catheter

Non-cesarean section group

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

Device: Balloon catheter

Interventions

Balloon catheter 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.

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; 5. 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.

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)

• 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.

  PMID: 30723900 BACKGROUND

• 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.

  PMID: 29490397 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: January 13, 2022
• First Posted: February 18, 2022
• Study Start: January 30, 2022
• Primary Completion: June 30, 2023
• Study Completion: December 30, 2024
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)