Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-04-08 @ 11:42 PM
Study NCT ID:
NCT07307092
Status:
COMPLETED
Last Update Posted:
2025-12-29
First Post:
2025-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intramuscular vs Rectal Progesterone in Preventing Preterm Labour After Cervical Cerclage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D002581', 'term': 'Uterine Cervical Incompetence'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D000026', 'term': 'Abortion, Habitual'}, {'id': 'D000022', 'term': 'Abortion, Spontaneous'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 820}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-13', 'studyFirstSubmitDate': '2025-12-13', 'studyFirstSubmitQcDate': '2025-12-13', 'lastUpdatePostDateStruct': {'date': '2025-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of Preterm Birth (<37 Weeks)', 'timeFrame': '16-36 weeks until delivery'}], 'secondaryOutcomes': [{'measure': 'Gestational Age at Delivery', 'timeFrame': 'At delivery'}, {'measure': 'Neonatal Birth Weight', 'timeFrame': 'At birth'}, {'measure': 'Apgar Scores at 1 and 5 Minutes', 'timeFrame': 'Immediately post-delivery'}, {'measure': 'NICU Admission Rate', 'timeFrame': 'Within 24 hours of birth'}, {'measure': 'Maternal Adverse Effects', 'timeFrame': 'During treatment period (16-36 weeks)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Interventions', 'Population', 'Study design', 'Clinical focus'], 'conditions': ['Preterm Labour', 'Cervical Insufficiency', 'Pregnancy, High-Risk']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Background:\n\nPreterm 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.\n\nObjective:\n\nTo compare the efficacy of intramuscular progesterone versus rectal progesterone in preventing preterm labour among women who underwent cervical cerclage.\n\nMethods:\n\nThis 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.\n\nSignificance:\n\nThis 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPregnant women aged 18-45 years\n\nSingleton pregnancy\n\nGestational age between 16 and 24 weeks at enrollment\n\nDiagnosed with cervical insufficiency and scheduled for or recently undergone cervical cerclage\n\nWilling to receive progesterone therapy and provide written informed consent\n\nExclusion Criteria:\n\nMultiple pregnancy\n\nKnown fetal anomalies\n\nSevere maternal comorbidities (e.g., hypertension, diabetes, cardiac disease)\n\nHistory of allergy or hypersensitivity to progesterone or related compounds\n\nContraindications to progesterone use\n\nWomen who declined to participate or were non-compliant with follow-upInclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07307092', 'acronym': 'PROCER', 'briefTitle': 'Intramuscular vs Rectal Progesterone in Preventing Preterm Labour After Cervical Cerclage', 'organization': {'class': 'OTHER', 'fullName': 'Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan'}, 'officialTitle': 'Comparison of Intramuscular Progesterone and Rectal Progesterone in the Prevention of Preterm Labour in Patients Undergoing Cervical Cerclage: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CMH-OBG-RCT-2025-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intramuscular Progesterone 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.', 'interventionNames': ['Drug: Intramuscular Progesterone', 'Drug: Rectal Progesterone']}, {'type': 'EXPERIMENTAL', 'label': 'Rectal Progesterone 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.', 'interventionNames': ['Drug: Intramuscular Progesterone', 'Drug: Rectal Progesterone']}], 'interventions': [{'name': 'Intramuscular Progesterone', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Intramuscular Progesterone Group', 'Rectal Progesterone Group']}, {'name': 'Rectal Progesterone', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Intramuscular Progesterone Group', 'Rectal Progesterone Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63100', 'city': 'Bahawalpur', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'CIMS Bahawalpur', 'geoPoint': {'lat': 29.39779, 'lon': 71.6752}}], 'overallOfficials': [{'name': 'Hina Mukhtar, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CMIS Bahawalpur'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hina Mukhtar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'DR', 'investigatorFullName': 'Hina Mukhtar', 'investigatorAffiliation': 'Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan'}}}}