Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-01-04 @ 5:08 PM
Study NCT ID:
NCT03698734
Status:
UNKNOWN
Last Update Posted:
2018-10-09
First Post:
2018-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evening Primrose Oil Efficacy in Second Trimester Abortion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000030', 'term': 'Abortion, Missed'}], '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': 'C028498', 'term': 'evening primrose oil'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2019-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-04', 'studyFirstSubmitDate': '2018-10-04', 'studyFirstSubmitQcDate': '2018-10-04', 'lastUpdatePostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'duration of medical induction of abortion', 'timeFrame': 'up to 1 week', 'description': 'time needed for complete expulsion of fetus and placenta'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Missed Abortion']}, 'descriptionModule': {'briefSummary': 'efficacy of evening primrose oil in shortening the duration of induction in 2nd trimesteric missed abortion'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primiparous women\n\nExclusion Criteria:\n\n* Previous uterine incision( Cs, myomectomy,)\n* Contraindications to medical or surgical uterine evacuations (eg, hemodynamically unstable, coagulopathy)\n* Evidence of intra-uterine infection\n* Rupture of fetal membranes.\n* Intrauterine device in place.\n* Allergy to prostaglandins or EPO'}, 'identificationModule': {'nctId': 'NCT03698734', 'briefTitle': 'Evening Primrose Oil Efficacy in Second Trimester Abortion', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Effect of Adding Evening Primrose Oil to Misoprostol in Second Trimester Abortion', 'orgStudyIdInfo': {'id': 'ASU obstetrics hosp'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Evening primrose oil', 'interventionNames': ['Drug: Evening primrose oil(EPO)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: Placebo - Cap']}], 'interventions': [{'name': 'Evening primrose oil(EPO)', 'type': 'DRUG', 'description': 'primiparous women with missed abortion between(13 to 24 weeks) will receive 1 capsule of EPO( 1000mg) in addition to misopristol', 'armGroupLabels': ['Evening primrose oil']}, {'name': 'Placebo - Cap', 'type': 'DRUG', 'description': 'primiparous women with missed abortion between(13 to 24 weeks) will receive 1 capsule of placebo in addition to misopristol', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11566', 'city': 'Cairo', 'state': 'Abbassya', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed K Maklad, MD', 'role': 'CONTACT'}], 'facility': 'AinShams university maternity hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Radwa R Ali, MD', 'role': 'CONTACT', 'email': 'radwaebed@yahoo.com', 'phone': '01283492979', 'phoneExt': '02002'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Radwa Rasheedy Ali', 'investigatorAffiliation': 'Ain Shams University'}}}}