NCT05197101

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

January 17, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2023

Completed
Last Updated

January 19, 2022

Status Verified

January 1, 2022

Enrollment Period

1 year

First QC Date

January 17, 2022

Last Update Submit

January 17, 2022

Conditions

Macrosomia, Fetal

Keywords

balloon catheteroxytocin

Outcome Measures

Primary Outcomes (1)

  • vaginal birth rate

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

    24 hours

Study Arms (1)

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

EXPERIMENTAL
Procedure: balloon catheter combined with oxytocin induction

Interventions

balloon catheter combined with oxytocin inductionPROCEDURE

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

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

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fetal Macrosomia

Condition Hierarchy (Ancestors)

Diabetes, GestationalPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFetal DiseasesPregnancy in DiabeticsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesBirth WeightBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Ziyan Jiang, doctor

CONTACT

13512534017zyjiangchm@163.com

Jinhai Tang

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2022

First Posted

January 19, 2022

Study Start

January 17, 2022

Primary Completion

January 17, 2023

Study Completion

March 17, 2023

Last Updated

January 19, 2022

Record last verified: 2022-01