Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2026-01-17 @ 1:00 AM
Study NCT ID:
NCT02255903
Status:
UNKNOWN
Last Update Posted:
2022-02-14
First Post:
2014-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Middle Cerebral To Umbilical Artery Doppler Ratio And Amniotic Fluid Volume Measurement In Post-date Pregnancies in King Khalid Military Central City
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Egypt']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011273', 'term': 'Pregnancy, Prolonged'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-30', 'studyFirstSubmitDate': '2014-09-26', 'studyFirstSubmitQcDate': '2014-09-30', 'lastUpdatePostDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse pregnancy outcome', 'timeFrame': 'at time of delivery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pregnancy, Prolonged']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the values of MCA PI / UA PI and MCA RI / UA RI ratios and amniotic fluid volume in predicting the adverse perinatal fetal outcome in uncomplicated postdate pregnancy', 'detailedDescription': 'The Study Will be a case-control study that will be conducted at Banha University Hospital and AFHSR in Saudi Arabia after the approval of Institutional ethical committee. One hundred pregnant women will be recruited from antenatal clinic. Starting from November 2022. An informed consent will be obtained from the patients . The patients will be subdivided into two groups:\n\nGroup 1(Control Group):consist of 100 pregnant females with gestational age 37-40 weeks.\n\nGroup 2 (post date Group):consist of 100 pregnant females with gestational age 41 weeks or more.\n\nInclusion criteria:\n\n1. Singleton, viable fetus in the vertex presentation.\n2. History of regular menstrual cycles.\n3. Gestational age calculated from the first day of last menstryal period or by first-trimester or second-trimester (before 20 weeks) ultrasound examination.\n4. No obstetric or medical complications of pregnancy apart from post-date pregnancy\n\nAll patients will be subjected to:\n\n1. Detailed history: including, personal history, menstural history, obstetric history, present history and past history.\n2. Physical examination: general, abdominal and pelvic examination.\n3. Investigations: including, A- Ultrasound examintion for amniotic fluid index (AFI) measurement.\n\nB- Doppler studies:\n\ni - Middle cerebral artery pulsatility index (MCA -PI) and resistace index(MCA-RI).\n\nii - Umbilical artery pulsatility index (UA-PI) and resistance index (UA-RI). iii - Cerebro-Placental ratio (CPR).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '48 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Two hundred pregnant women will be recruited from outpatient clinic. Starting from February 2022. An informed consent will be obtained from the patients . The patients will be subdivided into two groups:\n\nGroup 1(Control Group):consist of 100 pregnant females with gestational age 37-40 weeks.\n\nGroup 2 (post date Group):consist of 100 pregnant females with gestational age 41 weeks or more.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Singleton, viable fetus in the vertex presentation\n2. History of regular menstrual cycles\n3. Gestational age calculated from the first day of last menstryal period or by first-trimester or second-trimester (before 20 weeks) ultrasound examination\n4. No obstetric or medical complications of pregnancy apart from post-date pregnancy\n\nExclusion Criteria:\n\n1. Patients unsure of their dates\n2. Medical disorders with pregnancy as (hypertension, diabetes mellitus or Rh isoimmunization)\n3. Prelabor rupture of membranes\n4. Polyhydramnios\n5. Women with multiple pregnancy\n6. Congenital fetal anomalies\n7. Antepartum hemorrhage\n8. Previus cesarean section\n9. Fetal malpresentation'}, 'identificationModule': {'nctId': 'NCT02255903', 'briefTitle': 'Middle Cerebral To Umbilical Artery Doppler Ratio And Amniotic Fluid Volume Measurement In Post-date Pregnancies in King Khalid Military Central City', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Middle Cerebral To Umbilical Artery Doppler Ratio And Amniotic Fluid Volume Measurement In Post-date Pregnancies in King Faisal Military Central City', 'orgStudyIdInfo': {'id': 'khalid-mohamed'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1(Control Group):', 'description': 'ultrasound and Doppler examination: of 100 pregnant females with gestational age 37-40 weeks.', 'interventionNames': ['Other: ultrasound and Doppler examination']}, {'label': 'Group 2 (post date Group)', 'description': 'ultrasound and Doppler examination:will be done for 100 pregnant females with gestational age 41 weeks or more', 'interventionNames': ['Other: ultrasound and Doppler examination']}], 'interventions': [{'name': 'ultrasound and Doppler examination', 'type': 'OTHER', 'description': 'ultrasound and Doppler examination: Trans-abdominal ultrasound examination will be peformed to all patienst while women in a slightly tilted position with the head of the bed raised 30 degrees and with a small pillow under the right lion', 'armGroupLabels': ['Group 1(Control Group):', 'Group 2 (post date Group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10018', 'city': 'Khamis Mushait', 'state': 'Afhsa', 'status': 'RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'name': 'khalid ibrahum, MD', 'role': 'CONTACT', 'email': 'dr.khalidkhader77@yahoo.com', 'phone': '201281469651'}], 'facility': 'AFHSR', 'geoPoint': {'lat': 18.3, 'lon': 42.73333}}], 'centralContacts': [{'name': 'khalid Ibrahim, MD', 'role': 'CONTACT', 'email': 'dr.khalidkhader77@yahoo.com', 'phone': '201281469651'}, {'name': 'KHALID IBRAHIM, MD', 'role': 'CONTACT', 'phone': '966596984055'}], 'overallOfficials': [{'name': 'khalid ibrahim, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Armed Forces Hospitals, Southern Region, Saudi Arabia'}, {'name': 'KHALID IBRAHIM, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Armed Forces Hospitals, Southern Region, Saudi Arabia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer and consultant of oblgyne', 'investigatorFullName': 'khalid abd aziz mohamed', 'investigatorAffiliation': 'Benha University'}}}}