Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2026-01-02 @ 12:13 AM
Study NCT ID:
NCT07067593
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-16
First Post:
2025-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Amnioreduction in Polyhydramnios
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006831', 'term': 'Polyhydramnios'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2025-07-06', 'studyFirstSubmitQcDate': '2025-07-15', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gestational age at delivery', 'timeFrame': '4 months', 'description': 'Determine Gestational age at delivery in polyhydramnios patients . Increased age is good.'}, {'measure': 'Rate of PROM', 'timeFrame': '4 months', 'description': 'Number of cases developed PROM'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Amnioreduction', 'Polyhydramnios'], 'conditions': ['Polyhydramnios']}, 'descriptionModule': {'briefSummary': 'The aim of this work is to review the indications, procedural complications and outcomes of amnioreduction in pregnancies complicated by polyhydramnios.', 'detailedDescription': "Polyhydramnios is the presence of excessive amniotic fluid in the amniotic sac and it's prevalence reaches 2% of all pregnancies . Polyhydramnios is diagnosed based on ultrasound criteria, as an amniotic fluid index (AFI) \\>25 cm or maximal vertical pocket \\> 8 cm . There is a recognized association of polyhydramnios and adverse pregnancy outcomes, including perinatal death, fetal abnormality and preterm birth . Management of the pregnancy can be problematic, particularly in severe cases, due to issues surrounding maternal discomfort and the risk of preterm birth. Amnioreduction, widely used in the management of polyhydramnios, is an option available to palliate maternal symptomatology and potentially prolong the pregnancy . Previous publications have shown a reduction in the risk for premature rupture of membranes and preterm labor decrease, placental perfusion improvement, and relief of maternal discomfort following amnioreduction"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "All pregnant women between 24 to 38 weeks attending Fetal Medicine Unit at Women's health hospital for antenatal care or admitted due to antepartum hemorrhage or for scheduled surgery and meeting the inclusion criteria are counseled to participate in our study after informed consent. sample size will be devided into 2 groups:\n\nGroup 1 : patients with Amnioreduction Group 2 : patients with conservative management (without amnioreduction)", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women 20- 38 weeks\n* Patients with polyhydramnios\n\nExclusion criteria:\n\n* Lethal fetal anomalies\n* Pre labor rupture of membranes\n* Placental separation\n* Chorioamnionitis'}, 'identificationModule': {'nctId': 'NCT07067593', 'briefTitle': 'Amnioreduction in Polyhydramnios', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Benefits and Risks of Amnioreduction for Management of Pregnant Women With Polyhydramnios', 'orgStudyIdInfo': {'id': 'AMN'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Amnioreduction'}, {'label': 'Conservative'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed Fekry', 'role': 'CONTACT', 'email': 'mohamedbeethoven2040@gmail.com', 'phone': '0882312388'}, {'name': 'Mohamed Fekry, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Women's Health Hospital", 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Mohamed Fekry, PhD', 'role': 'CONTACT', 'email': 'mohamedbeethoven2040@gmail.com', 'phone': '0882312388'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer obstetric and gynecology, Specialist Urogynecology', 'investigatorFullName': 'Mohamed Gamal M.fekry', 'investigatorAffiliation': 'Assiut University'}}}}