Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 12:32 AM
Study NCT ID:
NCT03475160
Status:
COMPLETED
Last Update Posted:
2018-03-23
First Post:
2018-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sildenafil Citrate and Recurrent Abortion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000026', 'term': 'Abortion, Habitual'}], 'ancestors': [{'id': 'D000022', 'term': 'Abortion, Spontaneous'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068677', 'term': 'Sildenafil Citrate'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Sildenafil Citrate (SC) vaginal suppositories compared to Placebo vaginal suppositories.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-16', 'studyFirstSubmitDate': '2018-03-09', 'studyFirstSubmitQcDate': '2018-03-16', 'lastUpdatePostDateStruct': {'date': '2018-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The difference between both groups in live birth', 'timeFrame': 'Through study completion, an average of 9 months.', 'description': 'Live birth is defined as an ongoing pregnancy past to the 20th week of gestation'}], 'secondaryOutcomes': [{'measure': 'Uterine artery PI at cycle day 21-23 preceding pregnancy', 'timeFrame': 'At cycle day 21-23 preceding pregnancy', 'description': 'The difference between both groups regard PI at cycle day 21-23 preceding pregnancy'}, {'measure': 'Uterine artery RI at cycle day 21-23 preceding pregnancy', 'timeFrame': 'At cycle day 21-23 preceding pregnancy', 'description': 'The difference between both groups regard RI at cycle day 21-23 preceding pregnancy'}, {'measure': 'Uterine artery PI at the twelfth week of gestation', 'timeFrame': 'At the twelfth week of gestation.', 'description': 'The difference between both groups regard PI at the twelfth week of gestation'}, {'measure': 'Uterine artery RI at the twelfth week of gestation', 'timeFrame': 'At the twelfth week of gestation.', 'description': 'The difference between both groups regard RI at the twelfth week of gestation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Recurrent Abortion']}, 'descriptionModule': {'briefSummary': 'Two groups of unexplained recurrent spontaneous abortion, each included 65 participants. scheduled randomly into; the study group received Sildenafil Citrate and Placebo group. The intervention started from day 21-23 of the cycle preceding spontaneous pregnancy and continued till the 12th-week of gestation.\n\nThe primary outcome measure was the difference in the live birth between both groups. Secondary outcome measures were the differences between both groups regard pulsatility index (PI) and resistance index (RI), a number of take-home babies, the reported side-effects of treatment and the pregnancy-related complications.', 'detailedDescription': 'Two groups of unexplained recurrent spontaneous abortion, each included 65 participants. scheduled randomly into; the study group received Sildenafil Citrate and Placebo group. The intervention started from day 21-23 of the cycle preceding spontaneous pregnancy and continued till the 12th-week of gestation.\n\nThe primary outcome measure was the difference in the live birth between both groups. Secondary outcome measures were the differences between both groups regard PI and RI, a number of take-home babies, the reported side-effects of treatment and the pregnancy-related complications, e.g., preeclampsia and intrauterine growth restriction (\\|IUGR).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unexplained recurrent spontaneous abortion.\n\nExclusion Criteria:\n\n* Abnormal uterine cavity.\n* Luteal phase insufficiency.\n* Endocrinal disorders, e.g., thyroid diseases, hyperprolactinemia, and Diabetes Mellitus.\n* Antiphospholipid syndrome.\n* Inherited or acquired thrombophilia.\n* Patients had renal, hepatic or cardiovascular diseases, hypertension, history of smoking, treated with vasodilators or sensitive to or developed severe side-effects with Sildenafil Citrate.'}, 'identificationModule': {'nctId': 'NCT03475160', 'briefTitle': 'Sildenafil Citrate and Recurrent Abortion', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Sildenafil Citrate for Treatment of Unexplained Recurrent Spontaneous Abortion', 'orgStudyIdInfo': {'id': '18199'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sildenafil Citrate', 'description': 'Sildenafil Citrate vaginal suppositories: 25 mg every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.', 'interventionNames': ['Drug: Sildenafil Citrate vaginal suppositories', 'Procedure: Uterine artery Doppler before treatment', 'Procedure: Uterine artery Doppler after treatment']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo vaginal suppositories: every 6 hours. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.', 'interventionNames': ['Drug: Placebo vaginal suppositories', 'Procedure: Uterine artery Doppler before treatment', 'Procedure: Uterine artery Doppler after treatment']}], 'interventions': [{'name': 'Sildenafil Citrate vaginal suppositories', 'type': 'DRUG', 'otherNames': ['Sildenafil Citrate'], 'description': 'Sildenafil citrate vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.', 'armGroupLabels': ['Sildenafil Citrate']}, {'name': 'Placebo vaginal suppositories', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Placebo vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.', 'armGroupLabels': ['Placebo']}, {'name': 'Uterine artery Doppler before treatment', 'type': 'PROCEDURE', 'description': 'Uterine artery Doppler before treatment: Uterine artery Doppler indices; PI and RI at cycle days 21-23 of the cycle preceding the pregnancy', 'armGroupLabels': ['Placebo', 'Sildenafil Citrate']}, {'name': 'Uterine artery Doppler after treatment', 'type': 'PROCEDURE', 'description': 'Uterine artery Doppler after treatment: Uterine artery Doppler indices; PI and RI at the twelfth week of gestation', 'armGroupLabels': ['Placebo', 'Sildenafil Citrate']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Department of Obstetrics and Gynecology', 'investigatorFullName': 'Ahmed Walid Anwar Murad', 'investigatorAffiliation': 'Benha University'}}}}