NCT07307092

Brief Summary

Preterm labour is a major cause of neonatal morbidity and mortality worldwide. Progesterone supplementation is known to help reduce the risk of preterm birth in high-risk women. This randomized controlled trial compared the effectiveness of intramuscular progesterone and rectal progesterone in preventing preterm labour among pregnant women who had undergone cervical cerclage. The study aimed to determine which route of progesterone administration provides better pregnancy prolongation and improved neonatal outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
820

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

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

October 26, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2022

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 29, 2025

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

December 13, 2025

Last Update Submit

December 13, 2025

Conditions

Preterm LabourCervical InsufficiencyPregnancy, High-Risk

Keywords

InterventionsPopulationStudy designClinical focus

Outcome Measures

Primary Outcomes (1)

  • Frequency of Preterm Birth (<37 Weeks)

    16-36 weeks until delivery

Secondary Outcomes (5)

  • Gestational Age at Delivery

    At delivery

  • Neonatal Birth Weight

    At birth

  • Apgar Scores at 1 and 5 Minutes

    Immediately post-delivery

  • NICU Admission Rate

    Within 24 hours of birth

  • Maternal Adverse Effects

    During treatment period (16-36 weeks)

Study Arms (2)

Intramuscular Progesterone Group

EXPERIMENTAL

Participants in this group received intramuscular progesterone (hydroxyprogesterone caproate) 250 mg once weekly, starting from 16 weeks until 36 weeks of gestation, following cervical cerclage. The injections were administered in the gluteal region under aseptic conditions. The purpose of this intervention was to maintain uterine quiescence and reduce the risk of preterm labour in high-risk pregnancies after cerclage.

Drug: Intramuscular ProgesteroneDrug: Rectal Progesterone

Rectal Progesterone Group

EXPERIMENTAL

Participants in this group received rectal progesterone suppositories 400 mg once daily, starting from 16 weeks until 36 weeks of gestation, following cervical cerclage. The suppositories were self-administered at bedtime. The aim of this intervention was to provide sustained progesterone support for maintaining uterine relaxation and reducing the risk of preterm labour after cerclage.

Drug: Intramuscular ProgesteroneDrug: Rectal Progesterone

Interventions

Intramuscular ProgesteroneDRUG

Hydroxyprogesterone caproate 250 mg administered intramuscularly once weekly from 16 to 36 weeks of gestation following cervical cerclage. Used to maintain uterine quiescence and prevent preterm labour.

Intramuscular Progesterone GroupRectal Progesterone Group
Rectal ProgesteroneDRUG

Micronized progesterone 400 mg suppository administered rectally once daily from 16 to 36 weeks of gestation following cervical cerclage. Intended to provide sustained progesterone support and prevent preterm labour.

Intramuscular Progesterone GroupRectal Progesterone Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women aged 18-45 years
  • Singleton pregnancy
  • Gestational age between 16 and 24 weeks at enrollment
  • Diagnosed with cervical insufficiency and scheduled for or recently undergone cervical cerclage
  • Willing to receive progesterone therapy and provide written informed consent

You may not qualify if:

  • Multiple pregnancy
  • Known fetal anomalies
  • Severe maternal comorbidities (e.g., hypertension, diabetes, cardiac disease)
  • History of allergy or hypersensitivity to progesterone or related compounds
  • Contraindications to progesterone use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIMS Bahawalpur

Bahawalpur, Punjab Province, 63100, Pakistan

Location

MeSH Terms

Conditions

Obstetric Labor, PrematureUterine Cervical Incompetence

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesAbortion, HabitualAbortion, SpontaneousGenital Diseases

Study Officials

  • Hina Mukhtar, MBBS

    CMIS Bahawalpur

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 13, 2025

First Posted

December 29, 2025

Study Start

October 26, 2021

Primary Completion

April 25, 2022

Study Completion

April 25, 2022

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)