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Intramuscular vs Rectal Progesterone in Preventing Preterm Labour After Cervical Cerclage

NCT07307092 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 820

Last updated 2025-12-29

No results posted yet for this study

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.

Conditions

  • Preterm Labour
  • Cervical Insufficiency
  • Pregnancy, High-Risk

Interventions

DRUG

Intramuscular Progesterone

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.

DRUG

Rectal Progesterone

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.

Sponsors & Collaborators

  • Hina Mukhtar

    lead OTHER

Principal Investigators

  • Hina Mukhtar, MBBS · CMIS Bahawalpur

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-26
Primary Completion
2022-04-25
Completion
2022-04-25

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07307092 on ClinicalTrials.gov