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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

Primary Purpose

Macrosomia, Fetal

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
balloon catheter combined with oxytocin induction
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Macrosomia, Fetal focused on measuring balloon catheter, oxytocin

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

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Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

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

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    January 17, 2022
    Last Updated
    January 17, 2022
    Sponsor
    The First Affiliated Hospital with Nanjing Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05197101
    Brief 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
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 17, 2022 (Anticipated)
    Primary Completion Date
    January 17, 2023 (Anticipated)
    Study Completion Date
    March 17, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The First Affiliated Hospital with Nanjing Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Macrosomia, Fetal
    Keywords
    balloon catheter, oxytocin

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    nulliparous women with estimated fetal weight ≥3500g at 39-40 weeks of gestation
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    balloon catheter combined with oxytocin induction
    Intervention Description
    Balloon catheter for 12 hours and oxytocin for up to 3days.If failed , they will be treated ceacrean.
    Primary Outcome Measure Information:
    Title
    vaginal birth rate
    Description
    After spontaneous labor for up tp 24 hous, the mode of delivery will be konwn and recorded.
    Time Frame
    24 hours

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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 -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ziyan Jiang, doctor
    Phone
    13512534017
    Email
    zyjiangchm@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jinhai Tang

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    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

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