Carbetocin Versus Ergometrine in the Management of Atonic Post Partum Haemorrhage (PPH) in Women Delivered Vaginally

• ClinicalTrials.gov Identifier: NCT02410759
• Recruitment Status: Unknown
• First Posted: April 8, 2015
• Last Update Posted: July 6, 2016
• Sponsor: Cairo University
• Information provided by (Responsible Party): AbdelGany Hassan, Cairo University

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Post Partum Hemorrhage	Drug: Carbetocin; Drug: Ergometrine	Phase 3

Detailed Description:

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.

Risk 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.

Oxytocin 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.

Carbetocin 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.

200 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.

Once 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.

The 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Carbetocin Versus Oxytocin in the Management of Atonic Post Partum Haemorrhage (PPH) in Women Delivered Vaginally: A Randomised Controlled Trial
• Study Start Date: April 2015
• Estimated Primary Completion Date: March 2017

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Carbetocin; 100 women with atonic PPH will receive Carbetocin 100 µgm slowly IM	Drug: Carbetocin; 100 women with atonic PPH will receive Carbetocin 100 µgm IM
Active Comparator: Ergometrine; 100 women with atonic PPH will receive Ergometrine 0.5mg IM	Drug: Ergometrine; 100 women with atonic PPH will receive Ergometrine 0.5 µgm IM

Outcome Measures

Primary Outcome Measures :

1. Need for other uterotonics [ Time Frame: 2 minutes after giving the drug. ]
   The uterus will be felt for the tone.

Secondary Outcome Measures :

1. Development of major PPH [ Time Frame: 10 minutes after giving the drug ]
   Swabs will be weighed and pictorial charts will be used to estimate the bleeding.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 40 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Women with atonic PPH.

Exclusion Criteria:

• Gestational age <37 weeks.
• Hypertension.
• Preeclampsia.
• Cardiac, renal or liver diseases
• Epilepsy.
• Known hypersensitivity to Carbetocin

Contacts and Locations

Contacts

Contact: AbdelGany MA Hassan, MRCOG, MD; +201017801604; abdelgany2@gmail.com

Locations

Egypt

BeniSuef University hospitals; Recruiting

BeniSuef, Egypt

Contact: Nesreen AA Shehata, MD +2001227866337 nesoomar@yahoo.com

Cairo university hospitals; Recruiting

Cairo, Egypt

Contact: AbdelGany Hassan, MRCOG, MD 002 01017801604 abdelgany2@gmail.com

Principal Investigator: AbdelGany MA Hassan, MRCOG, MD

Sub-Investigator: Mohamed MM Kotb, MD

Sponsors and Collaborators

Cairo University

Investigators

• Principal Investigator: AbdelGany M Hassan; Cairo University

More Information

Publications:

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. Erratum In: BJOG. 2011 Nov;118(12):1549.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: AbdelGany Hassan, Lecturer of Gynecology and Obstetrics, Cairo University
• ClinicalTrials.gov Identifier: NCT02410759
• Other Study ID Numbers: PPH5
• First Posted: April 8, 2015
• Last Update Posted: July 6, 2016
• Last Verified: July 2016

Additional relevant MeSH terms:

Postpartum Hemorrhage; Hemorrhage; Pathologic Processes; Obstetric Labor Complications; Pregnancy Complications; Puerperal Disorders; Uterine Hemorrhage; Carbetocin; Ergonovine; Oxytocics; Reproductive Control Agents; Physiological Effects of Drugs