To Evaluate the Efficacy and Safety of Balloon Catheter Combined With Oxytocin Induction in Nulliparous Women With Estimated Fetal Weight ≥3500g at 39-40 Weeks of Gestation

Macrosomia, Fetal Clinical Trial

Official title:

To Evaluate the Efficacy and Safety of Balloon Catheter Combined With Oxytocin Induction in Nulliparous Women With Estimated Fetal Weight ≥3500g at 39-40 Weeks of Gestation: a Randomized, Controlled, Observational Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05197101
• Other study ID #: PIIM
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 17, 2022
• Est. completion date: March 17, 2023

Study information

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

Clinical Trial Summary

This study is a randomized, controlled, observational study. 150 nulliparous women with estimated fetal weight ≥3500g at 39-40 weeks of gestation will be enrolled as subjects in the two groups is 1:1. In the experimental group, vaginal examination will be performed at 39 to 40 weeks to assess cervical conditions. If the bishop score <6, the balloon catheter combined with oxytocin induction will be planned at 40 weeks ±3 days. In the control group, one week to 41 weeks ±3 days will be expected. Vaginal examination will be performed again to evaluate cervical conditions. If the bishop score <6 points, and balloon catheter combined with oxytocin induction will be performed. 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: Not yet recruiting
• Enrollment: 150
• Est. completion date: March 17, 2023
• Est. primary completion date: January 17, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria: singleton head position pregnancy, negative Down's screening and /or NIPT screening, no malformation was found, with slight/without pregnancy complications - Exclusion Criteria:twin or multiple pregnancy, scar uterus, with contraindications to vaginal delivery, estimated fetal weight >4500g -

Related Conditions & MeSH terms

• Fetal Macrosomia
• Fetal Weight
• Macrosomia, Fetal

Intervention

Procedure:
• balloon catheter combined with oxytocin induction
Balloon catheter for 12 hours and oxytocin for up to 3days.If failed , they will be treated ceacrean.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vaginal birth rate	After spontaneous labor for up tp 24 hous, the mode of delivery will be konwn and recorded.	24 hours