NCT07685756

Brief Summary

Cervical ripening balloon compared with vaginal misoprostol for cervical ripening in obese woman at term

Trial Health

75
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress23%
May 2026Jun 2027

Study Start

First participant enrolled

May 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 6, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

July 6, 2026

Status Verified

May 1, 2026

Enrollment Period

8 months

First QC Date

June 29, 2026

Last Update Submit

June 29, 2026

Conditions

Cervical Ripening

Outcome Measures

Primary Outcomes (1)

  • Less rate of instrumental delivery and c section

    Less rate of instrumental delivery and c section in ripening of obese women with cervical folleys as compared to misoprostol at term

    12 months

Study Arms (2)

Experimental group having cervical ripening with cervical folleys

EXPERIMENTAL

We will study effectiveness of ripening with cervical folleys compared to misoprostol

Device: Cervical folleys

Experimental group having cervical ripening with misoprostol

ACTIVE COMPARATOR

We will compare effectiveness of ripening with misoprostol with cervical folleys

Drug: Misoprostol

Interventions

Cervical folleysDEVICE

We will compare effectiveness of cervical ripening with cervical folleys compared to misoprostol in obese women at term

Experimental group having cervical ripening with cervical folleys
MisoprostolDRUG

We will compare effectiveness of ripening with misoprostol comoared with cervical folleys in obese women at term

Experimental group having cervical ripening with misoprostol

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant females
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • obese women bmi \>30, Bishop score \<6 at time of ripening Singleton pregnancy Gestational age more than 37 weeks

You may not qualify if:

  • pregnancy with fetal demise congenital anomalies, History of uterine surgery In active labour \>4 cm dialated Obs complication History of uterine hyper stimulation and uterine rupture Feel malpresentation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan institute of medical sciences Islamabad

Islamabad, Punjab Province, 46604, Pakistan

Location

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Postgraduate resident

Study Record Dates

First Submitted

June 29, 2026

First Posted

July 6, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

July 6, 2026

Record last verified: 2026-05

Locations

PA(1)