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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

Sponsor
The First Affiliated Hospital with Nanjing Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05197101
Collaborator
(none)
150
Enrollment
1
Arm
13.9
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: balloon catheter combined with oxytocin induction
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Anticipated Study Start Date :
Jan 17, 2022
Anticipated Primary Completion Date :
Jan 17, 2023
Anticipated Study Completion Date :
Mar 17, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: nulliparous women with estimated fetal weight ≥3500g at 39-40 weeks of gestation

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.

Outcome Measures

Primary Outcome Measures

  1. vaginal birth rate [24 hours]

    After spontaneous labor for up tp 24 hous, the mode of delivery will be konwn and recorded.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No

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

-

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT05197101
Other Study ID Numbers:
  • PIIM
First Posted:
Jan 19, 2022
Last Update Posted:
Jan 19, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by The First Affiliated Hospital with Nanjing Medical University
balloon catheter
oxytocin
Additional relevant MeSH terms:
Fetal Macrosomia
Fetal Weight
Oxytocin

Study Results

No Results Posted as of Jan 19, 2022