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

Vaginal Birth After Cesarean Clinical Trial

Official title:

To Study the Effectiveness and Safety of Balloon Catheter Combined With Oxytocin Induction Among the Pregnant Women With Previous Cesarean Section: Multicenter, Prospective, Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05246761
• Other study ID #: JPPTOLAC-01
• Status: Recruiting
• Start date: January 30, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2022
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Jiang Ziyan, Ph.D
• Phone: 13512534017
• Email: zyjiangchm[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 924
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bishop Score
• Failed Mechanical Induction
• Unfavorable Cervix
• Vaginal Birth After Cesarean

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

Huisman CMA, Ten Eikelder MLG, Mast K, Oude Rengerink K, Jozwiak M, van Dunné 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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