Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-31 @ 5:08 PM
Study NCT ID:
NCT04548102
Status:
COMPLETED
Last Update Posted:
2020-09-14
First Post:
2020-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Intervention group versus control group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-10', 'studyFirstSubmitDate': '2020-08-26', 'studyFirstSubmitQcDate': '2020-09-10', 'lastUpdatePostDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decreased fetal movement count', 'timeFrame': '37 weeks gestation', 'description': "Mothers' self report"}, {'measure': 'Intrauterine fetal death', 'timeFrame': '37 weeks gestation', 'description': 'Antenatal follow up and examination'}, {'measure': 'Still birth', 'timeFrame': 'Within 24 hoursafter delivery', 'description': 'Deliver died fetus or died within 24hrs. after delivery'}, {'measure': 'NICU admission', 'timeFrame': '10 minutes after delivery', 'description': 'Newborn Apgar at fifth minutes less than 6'}], 'secondaryOutcomes': [{'measure': 'Pregnancy complications', 'timeFrame': '37 weeks gestation', 'description': "Any progress in mothers' medical conditions that affect thier pregnancy outcomes"}, {'measure': 'Delivery outcome', 'timeFrame': 'Immediatly after delivery', 'description': 'Mode of delivery and delivery complications'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fetal Movement', 'Maternal Outcome', 'Risk Pregnancy'], 'conditions': ['High Risk', 'Pregnancy']}, 'descriptionModule': {'briefSummary': 'Up till now, there is insufficient evidence that daily fetal movement counting for pregnant women who are already have a history of high risk pregnancy is beneficial or not in term of early detection and preventing adverse pregnancy outcomes.\n\nAim The aim of the current study is to evaluate the effect of fetal movement counting on maternal and fetal outcome', 'detailedDescription': "The researchers met the pregnant women in antenatal clinics during their routine follow up. Woman who was eligible to be recruited in the study signed the consent after description of the study's purpose. Pregnant women in the study group received verbal information regarding normal fetal movements (i.e. description of the changing pattern of movement as the fetus develops, normal sleep/wake cycles, and factors which may modify the mother's perception of movements such as maternal weight and placental position), and its importance to be followed during the third trimester. Further, each pregnant woman in the study group was trained how to count the fetal movement (i.e.lying down on her left side after taking her meal, and concentrating on fetal movements, calculate it three times per day, half an hour/ one time and record it in the chart). As a rule, if there are less than 10 movements felt in 2 hours, women should contact her health care provider immediately (Royal college of obstetrician \\& gynecologists, 2011). Fetal movements counting chart was provided and women telephoned once a week in order to ensure proper recording. They also asked to present the fetal movements' chart to the researcher and thier health care providers in each antenatal follow up visit. Pregnant women in both groups; the study and the control groups followed according to thier antenatal visits schedule till delivery. Women in the control group received the antenatal hospital standard care. The maternal and neonatal outcomes had been assessed at delivery unit."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Pregnant women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Second gravida\n* Singleton\n* 28 weeks gestation\n* History of pregnancy induced hypertension (PIH)\n* History of premature rupture of membrane (PROM)\n* History of preterm labor\n* History of gestational diabetes\n* History of antepartum hemorrhage\n* History of stillbirth\n* History of fetal growth restriction\n\nExclusion Criteria:\n\n* History of psychological problems\n* Drugs abuse\n* Experience any terrible life events during the past 6 months\n* Oligohydramnios\n* Multi-fetal pregnancy\n* Fetal abnormalities\n* Smoking'}, 'identificationModule': {'nctId': 'NCT04548102', 'briefTitle': 'Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '0003381'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fetal Movement Counting', 'description': 'Fetal movement counting', 'interventionNames': ['Other: Fetal movement count']}, {'type': 'NO_INTERVENTION', 'label': 'standard antenatal follow up care', 'description': 'Women in the control group received the antenatal hospital standard care.'}], 'interventions': [{'name': 'Fetal movement count', 'type': 'OTHER', 'description': "Pregnant women in the study group received verbal information regarding normal fetal movements (i.e. description of the changing pattern of movement as the fetus develops, normal sleep/wake cycles, and factors which may modify the mother's perception of movements such as maternal weight and placental position), and its importance to be followed during the third trimester. A chart for fetal movements counting provided and to ensure proper performance of this task, women telephoned once a week. They also asked to show the fetal movements chart to the researcher and the health care providers in each visit. Women followed according to her antenatal visits schedule till delivery.", 'armGroupLabels': ['Fetal Movement Counting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12944', 'city': 'Faisal', 'state': 'Giza Governorate', 'country': 'Egypt', 'facility': 'Rania Mahmoud Abdel Ghani', 'geoPoint': {'lat': 30.01744, 'lon': 31.20376}}], 'overallOfficials': [{'name': 'Rania Mahmoud A Ghani, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Nursing-Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assisstant professor', 'investigatorFullName': 'Rania Mahmoud Abdel Ghani', 'investigatorAffiliation': 'Cairo University'}}}}