NCT04325256

Brief Summary

Induction of labour (IOL) nowadays is a common procedure in obstetric practice. Presently, IOL is done for 20% of pregnancies for various maternal and fetal indications and nearly 20% of labour inductions end up in caesarean deliveries. The success of IOL mainly depends upon "favourability" of the cervix which is usually assessed by manual examination and Scored as Bishop Score. However, this method is limited by subjectivity and reproducibility and though done in all the patients prior to IOL, several studies have demonstrated poor correlation between Bishop Score and outcome of IOL

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

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

March 26, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 27, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

1.5 years

First QC Date

March 26, 2020

Last Update Submit

August 24, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • The rate of successful induction of labor

    an ability to achieve the active phase of labor corresponding to a cervical dilatation of ≥4 cm within 12 h of initiating oxytocin on the first day of induction

    24 hours

Study Arms (1)

study group

All pregnant women who will attend the labor unit for induction of labour due to different indications during the study period will be invited to participate in the study.

Procedure: Manipal ultrasound scoring systemProcedure: Levine scoring system

Interventions

length of the cervix from the internal to external os, presence or absence of funneling and if present width and length of funneling at internal os were measured. Distance between presenting part to external os will be measured and position of the cervix i.e. whether curved or straight will also noted.

study group

maternal height, parity, body-mass index (BMI) at delivery and the results of modified Bishop's score in calculation of probability of CS

study group

Eligibility Criteria

Sexfemale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

pregnant women who will attend the labor unit for induction

You may qualify if:

  • Singleton pregnancy.
  • Pregnant ≥ 37 weeks gestation.
  • Fetus with longitudinal lie and vertex presentation.
  • Intact membranes.
  • No vaginal bleeding.

You may not qualify if:

  • Patients with previous cesarean delivery.
  • Previous uterine surgery.
  • Antepartum hemorrhage.
  • Cephalopelvic disproportion.
  • Category II or III non-stress test.
  • Malpresentation.
  • Intrauterine fetal death.
  • Fetal growth restriction.
  • Fetuses with major congenital malformations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 26, 2020

First Posted

March 27, 2020

Study Start

December 1, 2020

Primary Completion

May 31, 2022

Study Completion

July 15, 2022

Last Updated

August 25, 2022

Record last verified: 2022-08

Locations