Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT05306405
Status:
UNKNOWN
Last Update Posted:
2022-04-01
First Post:
2022-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Study Between Only Vaginal Misoprostol and Vaginal Misoprostol and Estradiol Cream
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014622', 'term': 'Vaginal Creams, Foams, and Jellies'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D053566', 'term': 'Feminine Hygiene Products'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-23', 'studyFirstSubmitDate': '2022-02-18', 'studyFirstSubmitQcDate': '2022-03-23', 'lastUpdatePostDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Induction of labour with closed cervix', 'timeFrame': 'from 0 hours to 14 hours after induction of labour', 'description': 'assessment of uterine contractions and cervical opening of the pregnant females who are currently not in labour, to help them to reach normal vaginal delivery process.'}], 'secondaryOutcomes': [{'measure': 'The Whole Delivery time after induction of labour.', 'timeFrame': 'from 0 hours to the end of the delivery', 'description': 'The whole time from induction to the end of vaginal labour with complications that may arise as:\n\n-uterine hyperstimulation, postpartum hemorrhage, rupture of the uterus and neonatal morbidity, fetal distress, and fetal hypoxia.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cervical dilatation, Uneffaced cervix, closed os'], 'conditions': ['Cervix; Pregnancy']}, 'descriptionModule': {'briefSummary': 'To compare the safety and effectiveness of vaginal misoprostol with combined vaginal misoprostol and estradiol for induction of labour in unfavorable cervix', 'detailedDescription': 'Induction of labour (IOL) is the process of initiating contractions of pregnant persons who are currently not in labour, to help them achieve vaginal delivery within 24 to 48 hours. Cervical ripening is one of the methods that used for labour induction; it is "the use of pharmacological or other means to soften, efface, or dilate the cervix to increase the likelihood of a vaginal delivery". The two major techniques for cervical ripening are mechanical interventions (e.g. insertion of balloon catheters), and application of pharmacological agents (e.g. prostaglandins). Prostaglandins are one of the preferred methods for cervical ripening, including the agents dinoprostone and misoprostol\n\n. By the mid of-1980s prostaglandins had become established as the most effective pharmacological agents for inducing labour when the cervix is unripped. The vaginal route was found to be the most acceptable, providing good efficacy and acceptability for the parturient and it is the preferred choice now.\n\nDuring the past 15 years the introduction of misoprostol, the prostaglandinsE1(PGE1) which, unlike prostglandinsE2 (PGE2), is stable at room temperature and it is effective if it was taken orally, has been the major focus of attention for labour induction. It is also considerably cheaper than the alternative prostaglandin.\n\nWith the ever-increasing concentrations of estrogen in the maternal circulation leading to term pregnancy, the belief that this could be a trigger for the onset of spontaneous labour led the studies to explore estrogens for the induction of labour.\n\nEstradiol gel gives extra--amniotic, endocervical or vaginally or estradiol intramuscularly and estradiol gel extra-amniotic have been shown to produce some improved cervical favorability with minimal myometrial stimulation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age36:41 weeks.\n* Singleton pregnancy.\n* Absence of labour pain.\n* Living fetus with cephalic presentation.\n* Fetal weight \\< 4 k.gs.\n* No previous uterine surgical procedures.\n* No liquor abnormalities.\n* Bishop score \\< 5.\n\nExclusion Criteria:\n\n* \\- Multiple gestations. one of the contraindications of induction of labor as it may cause rupture of the uterus.\n* Liquor abnormalities.one of contraindications of induction of labor as it may cause fetal distress.\n* Abnormal umbilical artery Doppler indices or non-stress test as these indicate fetal distress.\n* Fetal weight \\> 4 kgs.as macrosomia is an indication of caesarean section for fear of shoulder dystocia .\n* Previous uterine surgery.contraindication of labor induction for fear of rupture uterus.\n* Asthmatic patient or women with allergy to prostaglandins or steroidal.\n* Non-vertex presentation.contraindication of labor induction as it may cause rupture uterus.\n* Fetal or maternal complications that might cause cesarean section.\n* Intrauterine fetal death.often induction of labor in women with a dead fetus is performed before term when the uterus may be less responsive to uterotonics than it is at term and this will affect the results of the study'}, 'identificationModule': {'nctId': 'NCT05306405', 'briefTitle': 'Comparative Study Between Only Vaginal Misoprostol and Vaginal Misoprostol and Estradiol Cream', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Comparative Study Between Using Only Vaginal Misoprostol and Using Vaginal Misoprostol and Estradiol Cream for Induction of Labour', 'orgStudyIdInfo': {'id': '001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'vaginal misoprostol', 'description': 'only vaginal misoprostol 25 μg tablets will be applied for induction of laour', 'interventionNames': ['Drug: Vaginal Tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'combined vaginal misoprostol and estradiol', 'description': 'vaginal misoprostol 25 μg (Vagiprost) tablets with vaginal estradiol 150 ml cream will be applied for induction of laour', 'interventionNames': ['Drug: Vaginal Tablet']}], 'interventions': [{'name': 'Vaginal Tablet', 'type': 'DRUG', 'otherNames': ['vaginal misoprostol and vaginal estradiol'], 'description': "Misoprostol alone will be repeated every 4 h in both groups for a maximum of 5 doses, reaching Bishop score \\>8, rupture of membranes or occurrence of labor pain.\n\nCervical evaluation will be done using Bishop's score. A score \\< 5 will be taken as unfavorable Cervix will be termed as ripped when Bishop's score equal 8 or more.\n\nThe endpoint of the study will be initiation of active phase of 1st stage of labor which commence from 6cm to full cervical dilatation", 'armGroupLabels': ['combined vaginal misoprostol and estradiol', 'vaginal misoprostol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': '.Fekria A Salama, Professor', 'role': 'CONTACT', 'email': 'dr_amiramaher@yahoo.com', 'phone': '+201092934978'}, {'name': 'Mortada S Ahmed, Professor', 'role': 'CONTACT', 'email': 'Mortada.elsayed80@gmail.com', 'phone': '+201001267054'}], 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Amira M Ahmed, MSC', 'role': 'CONTACT', 'email': 'dr_amiramaher@yahoo.com', 'phone': '+201090904528'}, {'name': 'Rania G Anwar, Lecturer', 'role': 'CONTACT', 'email': 'dr.raniagamal2015@yahoo.com', 'phone': '+2012832627054'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident of Obstetrics and Gynecology at Al-Delengat General Hospital', 'investigatorFullName': 'Amira Maher', 'investigatorAffiliation': 'Ain Shams University'}}}}