Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-01-31 @ 7:48 AM
Study NCT ID:
NCT02410759
Status:
UNKNOWN
Last Update Posted:
2016-07-06
First Post:
2015-03-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carbetocin Versus Ergometrine in the Management of Atonic Post Partum Haemorrhage (PPH) in Women Delivered Vaginally
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C020731', 'term': 'carbetocin'}, {'id': 'D004874', 'term': 'Ergonovine'}], 'ancestors': [{'id': 'D004873', 'term': 'Ergolines'}, {'id': 'D004876', 'term': 'Ergot Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'lastUpdateSubmitDate': '2016-07-03', 'studyFirstSubmitDate': '2015-03-31', 'studyFirstSubmitQcDate': '2015-04-02', 'lastUpdatePostDateStruct': {'date': '2016-07-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Need for other uterotonics', 'timeFrame': '2 minutes after giving the drug.', 'description': 'The uterus will be felt for the tone.'}], 'secondaryOutcomes': [{'measure': 'Development of major PPH', 'timeFrame': '10 minutes after giving the drug', 'description': 'Swabs will be weighed and pictorial charts will be used to estimate the bleeding.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Post Partum Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '21668768', 'type': 'BACKGROUND', 'citation': 'Moertl MG, Friedrich S, Kraschl J, Wadsack C, Lang U, Schlembach D. Haemodynamic effects of carbetocin and oxytocin given as intravenous bolus on women undergoing caesarean delivery: a randomised trial. BJOG. 2011 Oct;118(11):1349-56. doi: 10.1111/j.1471-0528.2011.03022.x. Epub 2011 Jun 14.'}, {'pmid': '17567419', 'type': 'BACKGROUND', 'citation': 'Winter C, Macfarlane A, Deneux-Tharaux C, Zhang WH, Alexander S, Brocklehurst P, Bouvier-Colle MH, Prendiville W, Cararach V, van Roosmalen J, Berbik I, Klein M, Ayres-de-Campos D, Erkkola R, Chiechi LM, Langhoff-Roos J, Stray-Pedersen B, Troeger C. Variations in policies for management of the third stage of labour and the immediate management of postpartum haemorrhage in Europe. BJOG. 2007 Jul;114(7):845-54. doi: 10.1111/j.1471-0528.2007.01377.x.'}, {'pmid': '33232518', 'type': 'DERIVED', 'citation': 'Parry Smith WR, Papadopoulou A, Thomas E, Tobias A, Price MJ, Meher S, Alfirevic Z, Weeks AD, Hofmeyr GJ, Gulmezoglu AM, Widmer M, Oladapo OT, Vogel JP, Althabe F, Coomarasamy A, Gallos ID. Uterotonic agents for first-line treatment of postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2020 Nov 24;11(11):CD012754. doi: 10.1002/14651858.CD012754.pub2.'}]}, 'descriptionModule': {'briefSummary': '200 women will be randomly divided into 2 equal groups using computer generated random numbers. Group 1 will receive Carbetocin 100 µgm (Pabal® Ferring, UK) and group 2 will receive ergometrine 0.5mg (methergin®, Novartis, Switzerland).', 'detailedDescription': "Obstetric haemorrhage remains one of the major causes of maternal death in both developed and developing countries. Postpartum haemorrhage (PPH) is defined as a blood loss \\>500 ml more of blood from the genital tract within 24 hours of the birth of a baby. PPH can be minor (500-1000 ml) or major (more than 1000 ml). The most frequent cause of PPH is uterine atony, contributing up to 80 % of the PPH cases.\n\nRisk factors of atonic PPH include multiple pregnancy, placenta previa, previous PPH, body mass index (BMI) \\>30, prolonged labour, fetal macrosomia\\>4kg and primipara\\> 40 years.\n\nOxytocin is currently the uterotonic of first choice. It has proven to decrease the incidence of PPH by 40 % and has a rapid onset of action and a good safety profile. A disadvantage of oxytocin is its short half-life of 4-10 min, regularly requiring a continuous intravenous infusion or repeated intramuscular injections.\n\nCarbetocin is a long-acting oxytocin analogue indicated for the prevention of uterine atony after child birth by cesarean section (CS) under epidural or spinal anaesthesia. Carbetocin has a rapid onset of action (within 1-2 min) and a prolonged duration of action (approximately 1 h) because of sustained uterine response with contractions of higher amplitude and frequency. Its safety profile is comparable to that of oxytocin The study will be conducted in Cairo university hospitals and BeniSuef university hospitals. All patients attending the labour ward will be invited to participate in the study in case they develop PPH, the invitation will include a clear full explanation of the study. Only patients signing informed written consents will participate in the study. All women will receive a prophylactic dose of oxytocin 5 i.u after delivery of the anterior shoulder.\n\n200 women with atonic PPH will be randomly divided into 2 equal groups using computer generated random numbers. Group 1 will receive Carbetocin 100 µgm (Pabal® Ferring, UK) and group 2 will receive ergometrine 0.5mg (Methergine®, Novartis, Switzerland). The investigators will not include a control group for ethical reasons.\n\nOnce atonic PPH is diagnosed, 2 14-gauge cannulas will be inserted and a crystalloid intravenous (iv) infusion will be started. The allocated drug will be diluted in 10ml saline and will be given slowly iv, the fundus will be rubbed, A Foley's catheter will be inserted and a fluid balance chart will be commenced, pulse and blood pressure will be recorded every 15 minutes, venepuncture will be done for cross matching 4 units of blood, full blood count and coagulation screen.\n\nThe uterine tone and amount of bleeding will be noted and the need for further uterotonic agents will be determined 2 minutes after giving the drug. Blood loss will be estimated through weighing the swabs and using pictorial charts. Blood haemoglobin will be assessed 24 hours after delivery."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with atonic PPH.\n\nExclusion Criteria:\n\n* Gestational age \\<37 weeks.\n* Hypertension.\n* Preeclampsia.\n* Cardiac, renal or liver diseases\n* Epilepsy.\n* Known hypersensitivity to Carbetocin'}, 'identificationModule': {'nctId': 'NCT02410759', 'briefTitle': 'Carbetocin Versus Ergometrine in the Management of Atonic Post Partum Haemorrhage (PPH) in Women Delivered Vaginally', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Carbetocin Versus Oxytocin in the Management of Atonic Post Partum Haemorrhage (PPH) in Women Delivered Vaginally: A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'PPH5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Carbetocin', 'description': '100 women with atonic PPH will receive Carbetocin 100 µgm slowly IM', 'interventionNames': ['Drug: Carbetocin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ergometrine', 'description': '100 women with atonic PPH will receive Ergometrine 0.5mg IM', 'interventionNames': ['Drug: Ergometrine']}], 'interventions': [{'name': 'Carbetocin', 'type': 'DRUG', 'description': '100 women with atonic PPH will receive Carbetocin 100 µgm IM', 'armGroupLabels': ['Carbetocin']}, {'name': 'Ergometrine', 'type': 'DRUG', 'description': '100 women with atonic PPH will receive Ergometrine 0.5 µgm IM', 'armGroupLabels': ['Ergometrine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'BeniSuef', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Nesreen AA Shehata, MD', 'role': 'CONTACT', 'email': 'nesoomar@yahoo.com', 'phone': '+2001227866337'}], 'facility': 'BeniSuef University hospitals'}, {'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'AbdelGany Hassan, MRCOG, MD', 'role': 'CONTACT', 'email': 'abdelgany2@gmail.com', 'phone': '002 01017801604'}, {'name': 'AbdelGany MA Hassan, MRCOG, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mohamed MM Kotb, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cairo university hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'AbdelGany MA Hassan, MRCOG, MD', 'role': 'CONTACT', 'email': 'abdelgany2@gmail.com', 'phone': '+201017801604'}], 'overallOfficials': [{'name': 'AbdelGany M Hassan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Gynecology and Obstetrics', 'investigatorFullName': 'AbdelGany Hassan', 'investigatorAffiliation': 'Cairo University'}}}}