Intramuscular vs Rectal Progesterone in Preventing Preterm Labour After Cervical Cerclage

NCT07307092 — Not applicable, Completed, 820 participants, Hina Mukhtar

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

Registry	NCT07307092, acronym PROCER
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	820 (Actual)
Sponsor	Hina Mukhtar (Other)
Conditions	Preterm Labour, Cervical Insufficiency, Pregnancy, High-Risk
Interventions	Intramuscular Progesterone, Rectal Progesterone (Drug)
Dates	start 2021-10-26, primary completion 2022-04-25, completion 2022-04-25, first posted 2025-12-29, last updated 2025-12-29
Locations	1 site in Pakistan

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Intramuscular Progesterone Group	Experimental	Drug: Intramuscular Progesterone; Drug: Rectal Progesterone	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.
Rectal Progesterone Group	Experimental	Drug: Intramuscular Progesterone; Drug: Rectal Progesterone	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.

Intramuscular Progesterone (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 (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.

+Outcome measures

Primary outcomes

Frequency of Preterm Birth (<37 Weeks) [16-36 weeks until delivery]

Secondary outcomes

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)]

+Eligibility

Sex: Female, ages: 18 Years to 45 Years

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:

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Exclusion Criteria:

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+Locations (1)

Facility	City	Country	Status
CIMS Bahawalpur	Bahawalpur, Punjab Province	Pakistan

+Investigators

Hina Mukhtar, MBBS, Principal investigator, CMIS Bahawalpur