Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2026-04-15 @ 11:04 AM
Study NCT ID:
NCT02223806
Status:
COMPLETED
Last Update Posted:
2016-11-25
First Post:
2014-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Active Management of the Third Stage of Labour: Uterine Tonus Assessment by Midwife vs. Patient Self-administration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006473', 'term': 'Postpartum Hemorrhage'}], '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': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 800}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-23', 'studyFirstSubmitDate': '2014-08-11', 'studyFirstSubmitQcDate': '2014-08-21', 'lastUpdatePostDateStruct': {'date': '2016-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postpartum hemorrhage (>500 ml blood loss)', 'timeFrame': 'within 24 hours postpartum', 'description': 'To determine whether there is a difference in effectiveness of routine uterine tonus assessment (every 15 minutes, for 2 hours) to prevent post-partum hemorrhage (≥500 ml blood loss) when performed by a midwife and self-administered by a patient.'}], 'secondaryOutcomes': [{'measure': 'Mean blood loss (in ml)', 'timeFrame': 'Within 24 hours postpartum'}, {'measure': 'Severe post-partum hemorrhage', 'timeFrame': 'Within 24 hours postpartum', 'description': '\\>1000ml blood loss'}, {'measure': 'Use of additional uterotonics', 'timeFrame': 'Within 24 hours postpartum'}, {'measure': 'Use of other procedures for management of postpartum hemorrhage', 'timeFrame': 'Within 24 hours postpartum', 'description': 'I.e. surgery, manual placenta tissue removal'}, {'measure': 'Late postpartum hemorrhage', 'timeFrame': 'From 24 hours and upto one week', 'description': 'Based on readmission'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Postpartum hemorrhage', 'Uterine tonus assessment', 'Active management of third stage of labor'], 'conditions': ['Postpartum Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '26683621', 'type': 'DERIVED', 'citation': 'Browne JL, Damale NK, Raams TM, Van der Linden EL, Maya ET, Doe R, Rijken MJ, Adanu R, Grobbee DE, Franx A, Klipstein-Grobusch K. Uterine Tonus Assessment by Midwives versus Patient self-assessment in the active management of the third stage of labor (UTAMP): study protocol for a randomized controlled trial. Trials. 2015 Dec 18;16:580. doi: 10.1186/s13063-015-1111-5.'}]}, 'descriptionModule': {'briefSummary': 'To determine whether there is a difference in effectiveness of routine uterine tonus assessment (every 15 minutes, for 2 hours) when performed by a midwife or self-administered by a patient on the incidence of postpartum haemorrhage, mean blood loss, and other maternal and neonatal outcomes.', 'detailedDescription': 'Rationale: Postpartum haemorrhage (PPH) is the most common cause of maternal death worldwide. The active management of the third stage of labour (AMTSL) is recognized as an effective strategy to prevent morbidity and mortality associated with PPH and reduce blood loss. AMTSL includes the provision of uterotonic drugs, controlled cord traction, delayed cord clamping and cutting, massage of the uterus, and monitoring of the uterine tonus. Although professional guidelines recommend the steps of AMTSL to be performed by health professionals, the reality of health professionals understaffed hospitals in many low- and middle income countries (LMICs) necessitates task-shifting of the final AMTSL component to patients. Yet, whether uterine tonus assessment yields the same effect when performed by patients and midwives has not been formally evaluated.\n\nObjective: To determine whether there is a difference in effectiveness of routine uterine tonus assessment (every 15 minutes, for 2 hours) when performed by a midwife or self-administered by a patient on the incidence of postpartum haemorrhage . mean blood loss, and other maternal and neonatal outcomes.\n\nStudy design: Randomized intervention study. Study population: Pregnant women admitted in the labour to the Korle Bu Teaching Hospital, Accra, Ghana Intervention: the intervention group will receive uterine tonus assessment every 15 minutes for 2 hours by a midwife, the control group will continue the current practice of self-assessment after patient education with regular monitoring of midwives.\n\nMain study parameters/endpoints: post-partum haemorrhage (\\>500 ml blood loss), severe postpartum haemorrhage (\\>1000 ml blood loss), mean blood loss, other maternal and neonatal outcomes.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will receive the standard of midwifery and obstetric care, and will have access to emergency obstetric interventions. All steps of the AMTSL will be performed, with the exemption of the last step of uterine tonus assessment for which women will be randomized to receive the intervention or current practice of care. Risk associated with the intervention are discomfort because of an external assessment. Data will be obtained from record books at the ward. Women will be asked for informed consent prior to participation. This study will be approved by the Ethical en Protocol Review Committee of the University of Ghana Medical School and the Medical Ethical Research Committee of the University Medical Center Utrecht.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Be in labor with an expected vaginal delivery, as assessed by the midwives\n* Gestation age ≥ 37 weeks\n* Received antenatal instructions on postnatal uterine tonus assessment\n* Provided informed consent.\n\nExclusion Criteria:\n\n* Age \\<18\n* Elective caesarean delivery\n* Severe anemia (\\<8g/dL)\n* Placenta praevia\n* Anticipated breech delivery\n* Referred patients who have not received antenatal care (ANC) uterine tonus assessment instructions\n* Multiple Pregnancy\n* Intra uterine fetal death'}, 'identificationModule': {'nctId': 'NCT02223806', 'acronym': 'UTAMP', 'briefTitle': 'Active Management of the Third Stage of Labour: Uterine Tonus Assessment by Midwife vs. Patient Self-administration', 'organization': {'class': 'OTHER', 'fullName': 'UMC Utrecht'}, 'officialTitle': 'Active Management of the Third Stage of Labour: Uterine Tonus Assessment by Midwife vs. Patient Self-administration', 'orgStudyIdInfo': {'id': 'UMC-GH 002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Self-assessment of uterine tonus', 'description': 'Uterine tonus assessment every 15 minutes for 2 hours by educated patient, which is standard-of-care.', 'interventionNames': ['Behavioral: Patient self-assessment of uterine tonus']}, {'type': 'EXPERIMENTAL', 'label': 'Midwife uterine tonus assessment', 'description': 'Uterine tonus assessment every 15 minutes for 2 hours by midwive.', 'interventionNames': ['Behavioral: Uterine Tonus Assessment by Midwife']}], 'interventions': [{'name': 'Uterine Tonus Assessment by Midwife', 'type': 'BEHAVIORAL', 'description': 'Uterine tonus assessment every 15 minutes for 2 hours.', 'armGroupLabels': ['Midwife uterine tonus assessment']}, {'name': 'Patient self-assessment of uterine tonus', 'type': 'BEHAVIORAL', 'description': 'Uterine tonus assessment by patient every 15 minutes for 2 hours.', 'armGroupLabels': ['Self-assessment of uterine tonus']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Accra', 'country': 'Ghana', 'facility': 'Korle Bu Teaching Hospital', 'geoPoint': {'lat': 5.55602, 'lon': -0.1969}}], 'overallOfficials': [{'name': 'Joyce L Browne, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Utrecht, the Netherlands'}, {'name': 'Kerstin D Klipstein-Grobusch, PhD MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Utrecht, The Netherlands'}, {'name': 'Nelson Damale, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korle-Bu Teaching Hospital, Accra, Ghana'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UMC Utrecht', 'class': 'OTHER'}, 'collaborators': [{'name': 'Korle-Bu Teaching Hospital, Accra, Ghana', 'class': 'OTHER'}, {'name': 'University of Ghana', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Joyce L. Browne', 'investigatorAffiliation': 'UMC Utrecht'}}}}