Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 12:55 PM
Study NCT ID:
NCT07248605
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Emergency Obstetric Care Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': "* The researcher will attend labor and delivery unit, emergency obstetric operating room and obstetric departments (9-10-15-18) at Mansoura University Hospital 3 days per week in cold days (Saturday, Monday and Wednesday) from 9:00 a.m. to 2:00 p.m. until the study sample is complete\n* The emergency obstetric care protocol will be carried out at pre-mentioned setting based on the results obtained from pre training assessment using the interviewing questionnaire and observational checklist.\n* Implementation of teaching and training will take (12) weeks. Nurses will be divided into (12) groups. Each group will include five nurses according to working circumstances and nurse's physical and mental readiness.\n* The overall sessions will be six sessions for each group divided into three theoretical sessions with a duration will be ranged from 30-45minutes for each, and three practical sessions while the duration of each practical session will be ranged from 30-60 minutes, The content will"}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2025-11-18', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Applying Emergency Obstetric Care Protocol on Maternity Nurses' Practices", 'timeFrame': 'after3 months of intervention', 'description': "Effect of Applying Emergency Obstetric Care Protocol on Maternity Nurses' Practices"}, {'measure': "Applying Emergency Obstetric Care Protocol on Maternity Nurses' Practices", 'timeFrame': 'after 3months of intervention', 'description': "Effect of Applying Emergency Obstetric Care Protocol on Maternity Nurses' Practices"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Emergency Care', 'Obstetric']}, 'referencesModule': {'references': [{'pmid': '30958834', 'type': 'RESULT', 'citation': 'Okonofua F, Ntoimo LFC, Ogu R, Galadanci H, Gana M, Adetoye D, Abe E, Okike O, Agholor K, Abdus-Salam RA, Randawa A, Abdullahi H, Daneji SM, Omo-Omorodion BI. Assessing the knowledge and skills on emergency obstetric care among health providers: Implications for health systems strengthening in Nigeria. PLoS One. 2019 Apr 8;14(4):e0213719. doi: 10.1371/journal.pone.0213719. eCollection 2019.'}, {'pmid': '34622945', 'type': 'RESULT', 'citation': 'Brogaard L, Glerup Lauridsen K, Lofgren B, Krogh K, Paltved C, Boie S, Hvidman L. The effects of obstetric emergency team training on patient outcome: A systematic review and meta-analysis. Acta Obstet Gynecol Scand. 2022 Jan;101(1):25-36. doi: 10.1111/aogs.14263. Epub 2021 Oct 8.'}, {'pmid': '33727325', 'type': 'RESULT', 'citation': 'Amosse F, Boene H, Kinshella MW, Drebit S, Sharma S, Makanga PT, Vala A, Magee LA, von Dadelszen P, Vidler M, Sevene E, Munguambe K; Community Level Interventions for Pre-eclampsia (CLIP) Working Group. Implementation of a Community Transport Strategy to Reduce Delays in Seeking Obstetric Care in Rural Mozambique. Glob Health Sci Pract. 2021 Mar 15;9(Suppl 1):S122-S136. doi: 10.9745/GHSP-D-20-00511. Print 2021 Mar 15.'}]}, 'descriptionModule': {'briefSummary': "This study aims to investigate the effect of applying emergency obstetric care protocol on maternity nurses' practices.", 'detailedDescription': "Effect of Applying Emergency Obstetric Care Protocol on Maternity Nurses' Practices Obstetrical emergencies are life threatening medical condition that occurs during pregnancy, labor or the postpartum period. Emergency Obstetric Care (EmOC) is categorized as Basic Emergency Obstetric Care (BEmOC) and Comprehensive Emergency Obstetric Care \\[CEmOC\\].\n\nTreatments within BEmOC include the administration of parenteral antibiotics, oxytocics and anticonvulsants, manual removal of the placenta, removal of retained products of conception and assisted vaginal delivery. Comprehensive Emergency Obstetric Care (CEmOC) includes all of these plus blood transfusion and cesarean section.\n\nThe World Health Organization (WHO), 2020, posits the following conditions as obstetrical emergencies, ectopic or tubal pregnancy, abruptio placenta, placenta previa, sever preeclampsia \\& eclampsia or pregnancy induced hypertension, premature rupture of membranes, amniotic fluid embolism, inversion or rupture of uterus, placenta accreta, prolapsed umbilical cord, shoulder dystocia, postpartum hemorrhage and postpartum infection.\n\nGlobally, every year an estimated 287,000 women die of complications during pregnancy or childbirth. There are a variety of obstetrical emergencies of pregnancy that can threaten the well-being of both mother and newborn baby (WHO, 2019). Worldwide, obstetrical emergencies are the leading causes of maternal mortality particularly in developing countries where lack of transport facilities, financial constraints due to poverty, illiteracy, ignorance, inadequate health infrastructure and meager blood bank facilities.\n\nLack of nurse's knowledge and skills on how to recognize and manage obstetrical emergencies contribute to substandard institutional care and preventable maternal deaths (Kenya National Bureau of Statistics \\[KNBS\\] and International Coach Federation \\[ICF\\], 2023). Many studies have shown that health workers lack for the knowledge and skills to provide good quality care.\n\nProper knowledge about identification signs, emergency measures to be taken and a well-equipped obstetrics unit can reduce maternal mortality by almost 35- 40%, Maternity nurses are the main frontline skilled health personnel providing maternity care services globally. When educated, trained and regulated to national and international standards, maternity nurses can provide 90% of the needed essential care for women and newborns.\n\nMost maternal complications are difficult to predict and prevent since any pregnant woman can develop them at any time during pregnancy, delivery or in the postpartum period (WHO, 2019). Thus, provision of effective, affordable and quality emergency obstetric care (EmOC) and efficient referral system plays pivotal role in promoting safe motherhood.\n\nImmediate nursing management of the emergency cases is depending on the prompt action of the nurse and midwife recognition of the problem. She needs to recognize the onset of complications, perform intervention and practical skills that enables her to give emergency obstetrical care including life saving measures when needed being technically up-to-date on the latest evidence based skills and identifying those who are at the potential risk and referring them for expert care.\n\nAlthough, pregnancy and childbirth is a normal process, complications may occur any time during antenatal or post natal period. Every delivery must be managed as an obstetrical emergency and all the preparation done to deal these emergencies. Skilled health professionals working in favorable environment should be available and able to attend to every pregnancy, delivery and must be available 24 hours a day, seven days a week.\n\nObstetrics emergency protocols are strategies geared towards reducing maternal deaths. The core elements of obstetrics emergency protocols include availability of skilled personnel to carry out effective interventions during pregnancy, delivery and postnatal period, availability of essential drugs and supplies and patient referrals.\n\nThe goals of emergency obstetric care protocol of critically ill women involve intensive monitoring and physiologic support for women with life-threatening to detect abnormal findings or subtle signs and symptoms of developing complications. Thus, the nursing contribution is very important to the rescue and mobilization of the team process to provide proper immediate care for the mother and the newborn and prevent any complication to be arises."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* of maternity nurses who are works in Obstetric departments , Emergency obstetric operating room and delivery unit\n\nExclusion Criteria:\n\n* nurses who are on long vocations at the time of data collection or have administrative work.'}, 'identificationModule': {'nctId': 'NCT07248605', 'briefTitle': 'Emergency Obstetric Care Protocol', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': "Effect of Applying Emergency Obstetric Care Protocol on Maternity Nurses' Practices", 'orgStudyIdInfo': {'id': 'Applying Emergency Obstetric C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'maternity nurses', 'description': 'maternity nurses who are works in predetermined setting will be recruited except nurses who are on long vocations at the time of data collection or have administrative work.', 'interventionNames': ['Procedure: educational booklet']}], 'interventions': [{'name': 'educational booklet', 'type': 'PROCEDURE', 'description': "Applying Emergency Obstetric Care Protocol on Maternity Nurses' Practices", 'armGroupLabels': ['maternity nurses']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Mansurah', 'country': 'Egypt', 'contacts': [{'name': 'Mansoura Uneversity uneversity', 'role': 'CONTACT', 'email': 'enursing@mans.edu.eg', 'phone': '0502200368'}, {'name': 'rania el-kurdy, doctor', 'role': 'CONTACT', 'phone': '+201006577020'}, {'name': 'Eman Nabil Ibrahim', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mansoura university', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Eman Nabil Ibrahim, PHd', 'role': 'CONTACT', 'email': 'neman0050@gmail.com', 'phone': '+201097795102'}, {'name': 'Rania Metwally El-kurdy, doctor', 'role': 'CONTACT', 'phone': '+201006577020'}], 'overallOfficials': [{'name': 'Eman Nabil Ibrahim, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mansoura Uneversity'}, {'name': 'Eman Nabil Ibrahim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Specialist Nurse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nursing Specialist at specialized medical hospital -mansouraa uneversity hospital', 'investigatorFullName': 'Eman Nabil Ibrahim Mohamed', 'investigatorAffiliation': 'Mansoura University'}}}}