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

Hina Mukhtar

Status: Completed

Conditions: Preterm Labour; Cervical Insufficiency; Pregnancy, High-Risk

Treatments: Drug: Rectal Progesterone; Drug: Intramuscular Progesterone

Study type: Interventional

Funder types: Other

Identifiers

NCT07307092

CMH-OBG-RCT-2025-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 820 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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:

-

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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820 participants in 2 patient groups

Intramuscular Progesterone Group

Experimental group

Description:

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.

Treatment:

Drug: Intramuscular Progesterone

Drug: Rectal Progesterone

Rectal Progesterone Group

Experimental group

Description:

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.

Treatment:

Drug: Intramuscular Progesterone

Drug: Rectal Progesterone