Intramuscular vs Rectal Progesterone in Preventing Preterm Labour After Cervical Cerclage

NCT ID: NCT07307092

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 820 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-26
• Study Completion Date: 2022-04-25

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.

Detailed Description

Background:

Preterm labour remains one of the leading causes of perinatal mortality and long-term neonatal complications. Cervical insufficiency, often managed by cervical cerclage, is a recognized risk factor for preterm birth. Progesterone supplementation helps maintain uterine quiescence and cervical integrity, but the optimal route of administration after cerclage is not well established.

Objective:

To compare the efficacy of intramuscular progesterone versus rectal progesterone in preventing preterm labour among women who underwent cervical cerclage.

Methods:

This single-centre, randomized controlled trial was conducted in the Department of Obstetrics & Gynecology, Bahawal Victoria Hospital, Bahawalpur, Pakistan. Eligible women with singleton pregnancies who had undergone cervical cerclage were randomly assigned to receive either weekly intramuscular progesterone (250 mg) or daily rectal progesterone suppositories (400 mg) from 16 to 36 weeks of gestation. The primary outcome was the incidence of preterm labour before 37 weeks. Secondary outcomes included gestational age at delivery, neonatal birth weight, NICU admission, and maternal side effects.

Significance:

This study provides evidence on the comparative effectiveness of two commonly used routes of progesterone administration in women with cerclage, aiming to identify the safer and more convenient regimen for prolonging pregnancy and improving neonatal outcomes.

Conditions

Preterm Labour; Cervical Insufficiency; Pregnancy, High-Risk

Keywords

Interventions; Population; Study design; Clinical focus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intramuscular Progesterone Group

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.

Group Type: EXPERIMENTAL

Intramuscular Progesterone

Intervention Type: DRUG

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.

Rectal Progesterone

Intervention Type: DRUG

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.

Rectal Progesterone Group

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.

Group Type: EXPERIMENTAL

Intramuscular Progesterone

Intervention Type: DRUG

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.

Rectal Progesterone

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

-

Exclusion Criteria

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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hina Mukhtar

OTHER

Sponsor Role: lead

Responsible Party

Hina Mukhtar

DR

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hina Mukhtar, MBBS

Role: PRINCIPAL_INVESTIGATOR

CMIS Bahawalpur

Locations

CIMS Bahawalpur

Bahawalpur, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

CMH-OBG-RCT-2025-01

Identifier Type: -

Identifier Source: org_study_id