Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT06713967
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-06
First Post:
2024-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Pregnancy Outcomes in Women with Polycystic Ovarian Syndrome with and Without Glucophage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}, {'id': 'D059039', 'term': 'Standard of Care'}, {'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-05-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2024-11-26', 'studyFirstSubmitQcDate': '2024-11-27', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of early pregnancy loss', 'timeFrame': 'From enrollment to 24 weeks of gestation.', 'description': 'The primary outcome of this study is to evaluate the rate of early pregnancy loss in pregnant women with polycystic ovarian syndrome (PCOS) who receive either Glucophage (metformin) or standard care (diet and exercise). Early pregnancy loss is defined as fetal death occurring before 24 weeks of gestation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polycystic Ovarian Syndrome (PCOS)', 'Pregnancy Outcomes']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if Glucophage (metformin) improves pregnancy outcomes in women with polycystic ovarian syndrome (PCOS). It will also evaluate the safety of Glucophage during pregnancy. The main questions it aims to answer are:\n\nDoes Glucophage reduce the risks of early pregnancy loss, preterm delivery, and gestational diabetes? Are there any medical problems associated with taking Glucophage during pregnancy? Researchers will compare Glucophage with standard care (diet and exercise) to see if it improves pregnancy outcomes in women with PCOS.\n\nParticipants will:\n\nTake Glucophage or follow a standard diet and exercise plan throughout pregnancy.\n\nAttend regular follow-up visits for checkups, ultrasounds, and blood tests. Have their pregnancy outcomes, such as fetal growth and gestational diabetes, recorded.', 'detailedDescription': 'This randomized controlled trial aims to evaluate the effectiveness of Glucophage (metformin) in improving pregnancy outcomes for women with polycystic ovarian syndrome (PCOS). The study compares two groups: one receiving standard diet and exercise along with Glucophage and another receiving only standard diet and exercise. Outcomes such as early pregnancy loss, preterm delivery, gestational diabetes, intrauterine growth restriction, and fetal malformations will be assessed.\n\nParticipants will be enrolled during their first trimester and followed through delivery. Data will be collected during regular follow-up visits, including ultrasound scans and oral glucose tolerance tests. The study will use statistical analysis to determine whether Glucophage significantly improves maternal and fetal health outcomes compared to standard care. Findings will help guide clinical management strategies for PCOS during pregnancy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPregnant females aged 18-40 years Diagnosed with polycystic ovarian syndrome (PCOS) before conception, as per operational definition.\n\nPresent in the 1st trimester at the booking visit. Singleton fetus on booking scan between 5th to 13th week of gestation.\n\nExclusion Criteria:\n\nFemales who do not give informed consent for follow-up. Females with preeclampsia (BP ≥140/90 mmHg with proteinuria \\>+1 on dipstick method).\n\nFemales already diagnosed with gestational diabetes (OGTT \\>186 mg/dl). Females already taking trial treatment (as per medical record). Twin pregnancy or abnormal placenta (assessed on ultrasound). Diagnosed hypertensives and diabetic patients.'}, 'identificationModule': {'nctId': 'NCT06713967', 'briefTitle': 'Comparison of Pregnancy Outcomes in Women with Polycystic Ovarian Syndrome with and Without Glucophage', 'organization': {'class': 'OTHER', 'fullName': 'University of Health Sciences Lahore'}, 'officialTitle': 'Comparison of Outcome of Pregnant Females with Polycystic Ovarian Syndrome with or Without Glucophage', 'orgStudyIdInfo': {'id': 'Exp126'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glucophage Treatment Group', 'description': 'In this arm, participants will receive a standard diet and exercise plan along with Glucophage (metformin). Metformin will be administered starting at 500 mg daily and gradually increased to 1500 mg daily for non-obese participants and 2000 mg daily for obese participants, starting from the second week of pregnancy until delivery. The goal is to evaluate the effectiveness of Glucophage in improving pregnancy outcomes for women with PCOS, including reducing early pregnancy loss, preterm delivery, gestational diabetes, and intrauterine growth restriction.', 'interventionNames': ['Procedure: Metformin (Glucophage)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Care Group:', 'description': 'Participants in this arm will receive a standard diet and exercise plan but will not receive any pharmacological intervention. This group will serve as a comparison to assess the impact of Glucophage on pregnancy outcomes in women with PCOS. All participants will be closely monitored throughout the pregnancy with regular follow-up visits and ultrasounds.', 'interventionNames': ['Procedure: Standard Care (Diet and Exercise Only)']}], 'interventions': [{'name': 'Metformin (Glucophage)', 'type': 'PROCEDURE', 'description': 'In this intervention, participants will receive oral metformin (500 mg daily, gradually increasing to 1500 mg daily for non-obese participants and 2000 mg daily for obese participants) starting from the second week of pregnancy and continuing until delivery. Metformin will be administered in combination with a standard diet and exercise plan. The intervention aims to evaluate the impact of metformin on pregnancy outcomes in women with polycystic ovarian syndrome (PCOS), focusing on reducing complications such as early pregnancy loss, preterm delivery, gestational diabetes, and intrauterine growth restriction. Participants will be regularly monitored with follow-up visits, ultrasounds, and glucose tests to assess the effectiveness of the treatment.', 'armGroupLabels': ['Glucophage Treatment Group']}, {'name': 'Standard Care (Diet and Exercise Only)', 'type': 'PROCEDURE', 'description': 'In this intervention, participants will receive a standard diet and exercise plan designed to promote a healthy pregnancy. This intervention does not include any pharmacological treatment, such as metformin. The goal is to evaluate the pregnancy outcomes in women with polycystic ovarian syndrome (PCOS) managed with lifestyle modifications alone, without the added effect of medication. Participants will be monitored through regular follow-up visits, ultrasounds, and glucose tests to track pregnancy progress, including the occurrence of gestational diabetes, preterm delivery, early pregnancy loss, and fetal growth restriction.', 'armGroupLabels': ['Standard Care Group:']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Amina Waheed, MS (OBSTETRICS & GYNAECOLOGY)', 'role': 'CONTACT', 'email': 'aminawaheed94@gmail.com', 'phone': '0331-6138096'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Health Sciences Lahore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Post Graduate Resident', 'investigatorFullName': 'Dr. Amina Waheed', 'investigatorAffiliation': 'University of Health Sciences Lahore'}}}}