NCT06056141

Brief Summary

Comparison of efficacy and safety of low-dose oral Misoprostol versus folley catheter for preinduction in women with an immature cervix at term.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 21, 2025

Status Verified

February 1, 2025

Enrollment Period

1 year

First QC Date

September 18, 2023

Last Update Submit

February 20, 2025

Conditions

Induction of Labor

Keywords

Induction of laborlow dose misoprostolFoley Catheter

Outcome Measures

Primary Outcomes (1)

  • Efficiency of induction

    Number of Participants with vaginal births within 24 hours.

    24 hours.

Secondary Outcomes (2)

  • Safety for baby

    5 min

  • Safety for mother

    during the labour induction

Study Arms (2)

Group A

ACTIVE COMPARATOR

Drug: Misoprostol 25mcg (200 mcg dissolved with 200 ml water and divided to 8 doses) every 2 hours

Drug: Misoprostol 200mcg Tab

Group B

ACTIVE COMPARATOR

Device: Foley Catheter Transcervical Foley catheter (silicone, size 20F with 30ml balloon)

Device: Foley Catheter

Interventions

Misoprostol 200mcg TabDRUG

Misoprostol 200 mcg dissolvedwith 200 ml water and divided to 25ml solution every 2 hours per os for maximum of 8 doses

Group A
Foley CatheterDEVICE

Transcervical Foley catheter (silicone, size 20F with 30ml balloon)

Group B

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • women with an unfavourable cervix who will scheduled for induction of labour

You may not qualify if:

  • Women with previous caesarean sections unable to give informed consent Multiple pregnancy History of allergy to misoprostol Ruptured membranes Chorioamnionitis All cases when physiological childbirth is impossible (placenta previa,transverse position of the fetus )

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

City Perinatology Centre 3

Almaty, 050062, Kazakhstan

Location

Center for Perinatology and Pediatric Cardiac Surgery

Almaty, A15H0K1, Kazakhstan

Location

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: multicentre randomised controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 18, 2023

First Posted

September 28, 2023

Study Start

October 1, 2023

Primary Completion

October 1, 2024

Study Completion

December 1, 2024

Last Updated

February 21, 2025

Record last verified: 2025-02

Locations

KA(2)