Intramuscular vs Rectal Progesterone in Preventing Preterm Labour After Cervical Cerclage (PROCER)

Comparison of Intramuscular Progesterone and Rectal Progesterone in the Prevention of Preterm Labour in Patients Undergoing Cervical Cerclage: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Cervical Insufficiency; Preterm Labour; Pregnancy, High-Risk
• Intervention / Treatment: Drug: Intramuscular Progesterone; Drug: Rectal Progesterone

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.

• Study Type: Interventional
• Enrollment (Actual): 820
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Bahawalpur, Punjab Province, Pakistan, 63100
      • CIMS Bahawalpur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Women who declined to participate or were non-compliant with follow-upInclusion Criteria:

-

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of Preterm Birth (<37 Weeks)	16-36 weeks until delivery

Secondary Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Hina Mukhtar
• Investigators: Principal Investigator: Hina Mukhtar, MBBS, CMIS Bahawalpur

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2021
• Primary Completion (Actual): April 25, 2022
• Study Completion (Actual): April 25, 2022

Study Registration Dates

• First Submitted: December 13, 2025
• First Submitted That Met QC Criteria: December 13, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Population; Interventions; Study design; Clinical focus
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Uterine Cervical Diseases; Abortion, Habitual; Abortion, Spontaneous; Obstetric Labor, Premature; Uterine Cervical Incompetence
• Other Study ID Numbers: CMH-OBG-RCT-2025-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No