Carbetocin Versus Ergometrine in the Management of Atonic Post Partum Haemorrhage (PPH) in Women Delivered Vaginally
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|ClinicalTrials.gov Identifier: NCT02410759|
Recruitment Status : Unknown
Verified July 2016 by AbdelGany Hassan, Cairo University.
Recruitment status was: Recruiting
First Posted : April 8, 2015
Last Update Posted : July 6, 2016
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|Condition or disease||Intervention/treatment||Phase|
|Post Partum Hemorrhage||Drug: Carbetocin Drug: Ergometrine||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
Active Comparator: Carbetocin
100 women with atonic PPH will receive Carbetocin 100 µgm slowly IM
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
100 women with atonic PPH will receive Ergometrine 0.5 µgm IM
- Need for other uterotonics [ Time Frame: 2 minutes after giving the drug. ]The uterus will be felt for the tone.
- 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.
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|Ages Eligible for Study:||20 Years to 40 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- Women with atonic PPH.
- Gestational age <37 weeks.
- Cardiac, renal or liver diseases
- Known hypersensitivity to Carbetocin
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02410759
|Contact: AbdelGany MA Hassan, MRCOG, MDfirstname.lastname@example.org|
|BeniSuef University hospitals||Recruiting|
|Contact: Nesreen AA Shehata, MD +2001227866337 email@example.com|
|Cairo university hospitals||Recruiting|
|Contact: AbdelGany Hassan, MRCOG, MD 002 01017801604 firstname.lastname@example.org|
|Principal Investigator: AbdelGany MA Hassan, MRCOG, MD|
|Sub-Investigator: Mohamed MM Kotb, MD|
|Principal Investigator:||AbdelGany M Hassan||Cairo University|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||AbdelGany Hassan, Lecturer of Gynecology and Obstetrics, Cairo University|
|Other Study ID Numbers:||
|First Posted:||April 8, 2015 Key Record Dates|
|Last Update Posted:||July 6, 2016|
|Last Verified:||July 2016|
Obstetric Labor Complications
Reproductive Control Agents
Physiological Effects of Drugs