NCT07416487

Brief Summary

There are gaps in the local data regarding the comparative effectiveness of Foley catheter versus misoprostol for induction of labor (IOL). Therefore, the current study was planned with the objective of comparing the mean induction-to-delivery interval of Foley catheter versus misoprostol for IOL in singleton term pregnancy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

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

Study Start

First participant enrolled

February 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

February 10, 2026

Last Update Submit

February 10, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Delivery of the fetus

    Induction-to-delivery interval was calculated from the insertion of the Foley catheter or misoprostol until the delivery of the fetus in hours.

    24 hours

Study Arms (2)

Misoprostol Group

EXPERIMENTAL

Women received intravaginal misoprostol 25 μg 4 hours apart, up to a maximum of four doses.

Drug: Misoprostol

Foley Group

EXPERIMENTAL

An intracervical Foley catheter (16 F) was inserted into the patients. The balloon was inflated with 30 mL of sterile normal saline solution and was kept in place until it expelled spontaneously.

Device: Foley catheter

Interventions

Women received intravaginal misoprostol 25 μg 4 hours apart, up to a maximum of four doses.

Misoprostol Group

An intracervical Foley catheter (16 F) was inserted into the patients. The balloon was inflated with 30 mL of sterile normal saline solution and was kept in place until it expelled spontaneously.

Foley Group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant females
  • years
  • With a singleton term pregnancy (37-41) weeks
  • Parity \< 4
  • Vertex presentation (on ultrasound scan)
  • Intact membranes (on history and clinical examination)
  • Going through labor induction

You may not qualify if:

  • With a previous uterine surgery
  • Non-reassuring cardiotocography (CTG)
  • Oligohydramnios (on ultrasound scan)
  • Intrauterine growth restriction (IUGR) (on ultrasound scan)
  • Abruptio placenta (on ultrasound scan).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

D.G. Khan Medical College/Allama Iqbal Teaching Hospital

Dera Ghazi Khan, Punjab Province, 32200, Pakistan

Location

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Zunera Sumbal

    D.G. Khan Medical College/Allama Iqbal Teaching Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Consultant

Study Record Dates

First Submitted

February 10, 2026

First Posted

February 18, 2026

Study Start

February 1, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Data can be shared on a reasonable request.

Locations