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

NCT ID: NCT05197101

Last Updated: 2022-01-19

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

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-17

Study Completion Date

2023-03-17

Brief Summary

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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.

Detailed Description

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Conditions

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Macrosomia, Fetal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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nulliparous women with estimated fetal weight ≥3500g at 39-40 weeks of gestation

Group Type EXPERIMENTAL

balloon catheter combined with oxytocin induction

Intervention Type PROCEDURE

Balloon catheter for 12 hours and oxytocin for up to 3days.If failed , they will be treated ceacrean.

Interventions

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balloon catheter combined with oxytocin induction

Balloon catheter for 12 hours and oxytocin for up to 3days.If failed , they will be treated ceacrean.

Intervention Type PROCEDURE

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

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

Central Contacts

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Ziyan Jiang, doctor

Role: CONTACT

13512534017

Jinhai Tang

Role: CONTACT

Other Identifiers

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PIIM

Identifier Type: -

Identifier Source: org_study_id

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