Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-03-01 @ 1:48 AM
Study NCT ID:
NCT03321435
Status:
COMPLETED
Last Update Posted:
2017-11-17
First Post:
2017-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Placenta Previa and Fetal Weight
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010923', 'term': 'Placenta Previa'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D010922', 'term': 'Placenta Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-14', 'studyFirstSubmitDate': '2017-10-21', 'studyFirstSubmitQcDate': '2017-10-24', 'lastUpdatePostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimated fetal wight (gram)', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'The value of Doppler indices in uterine artery', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Placenta Previa']}, 'descriptionModule': {'briefSummary': 'Placenta previa is a placenta that implants at lower uterine segment, it occurs in about 0.3-0.5% of pregnancies at term. It is a significant risk for development of maternal morbidity, as well as maternal mortality secondary to maternal hemorrhage . Also, this abnormal placenta has a negative concern about fetal well being due to prematurity and perinatal mortality, in addition to its undesirable effect on fetal growth. Several factors may be behind of the effect of placenta previa on fetal growth. Firstly, the blood supply to the lower uterine segment is less than at the upper segment apparently resulting in less feto-placental blood perfusion . Secondly, recurrent bleeding attacks from placental previa may affect fetal oxygenation and fetal growth.\n\nIn spite of above evidences; many studies in literature denied the relation between placenta previa and fetal growth and concluded that the association between low birth weight and placenta previa is mainly due to preterm delivery and to a lesser extent with fetal growth restriction. However; the major drawback of all these studies is lacking of reporting the effect of placenta previa of feto-maternal blood flow representing in studying of Doppler blood flow in both uterine and umbilical artery in those patients. The uterine artery blood flow is usually affected by the presence of placenta previa and placenta accreta which reflected on feto-placental blood flow. So the uterine artery Doppler velocimetry is a useful tool for predicting placenta accreta .\n\nSo in the light of above evidences; we aimed, in the current study, not only to investigate the effect on placenta previa on fetal weight but also to walk around the effect of placenta previa on the uterine and umbilical arteries blood flow in trial to explore this conflicting issue. To our knowledge, no previous trial had studied this interesting subject before.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'placenta previa patients', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Women who are sure of her pregnancy.\n2. Women aged 20-35 years.\n3. Women with BMI 18-22 kg/m2.\n4. Estimated gestational age is ranging between 30- 32 weeks gestation.\n5. Singleton pregnancy.\n6. Placenta previa; either major or minor degrees as regard the cases.\n7. Placenta previa with minimal vaginal bleeding or haven't any vaginal bleeding.\n8. Women with normal Doppler indices in uterine and umbilical arteries at time of recruitment.\n9. Women should be living in a nearby area to make follow-up and early transportation are reasonably possible.\n\nExclusion Criteria:\n\n1. Women aged \\< 20 and \\>35 years.\n2. Smoker ≥ 11 cigarettes/day.\n3. Severe attack of bleeding requiring an immediate intervention.\n4. Fetal heart rates instability or non reassuring.\n5. Multiple gestations.\n6. Previous Intrauterine growth restricted fetus.\n7. Intrauterine fetal death or major fetal anomalies.\n8. If associated with abruptio placentae.\n9. Patients with known bleeding disorders or on anticoagulant therapy"}, 'identificationModule': {'nctId': 'NCT03321435', 'briefTitle': 'The Placenta Previa and Fetal Weight', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Effect of Placenta Previa on Fetal Weight and Feto-maternal Blood Flow', 'orgStudyIdInfo': {'id': 'PPIUGR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'placenta previa group', 'interventionNames': ['Other: placenta previa patient']}, {'label': 'Normal control group', 'interventionNames': ['Other: normal women']}], 'interventions': [{'name': 'placenta previa patient', 'type': 'OTHER', 'description': 'women had placenta previa either major or minor degree', 'armGroupLabels': ['placenta previa group']}, {'name': 'normal women', 'type': 'OTHER', 'description': 'those women had not placenta previa', 'armGroupLabels': ['Normal control group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Mohammed Khairy Ali', 'investigatorAffiliation': 'Assiut University'}}}}