Ergometrine Versus Oxytocin in the Management of Atonic Post-partum Haemorrhage (PPH) in Women Delivered Vaginally

Ergometrine Versus Oxytocin in the Management of Atonic Post-partum Haemorrhage (PPH) in Women Delivered Vaginally: A Randomised Controlled Trial

Patrocinadores

Patrocinador principal: Cairo University

Fuente Cairo University
Resumen breve

200 women with PPH will be randomly divided into 2 equal groups using computer generated random numbers. Group 1 will receive Ergometrine 400µgm (Methergin® Novartis, Switzerland) and group 2 will receive oxytocin 10 IU (Syntocinon®, Novartis, Switzerland). The investigators will not include a control group for ethical reasons.

Descripción detallada

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. Despite decades of empirical use in clinical practice, there are no trials comparing ergometrine and oxytocin as first-line agents for the treatment (rather than prevention) of PPH.

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, the invitation will include a clear full explanation of the study. Only patients signing informed written consents will participate in the study.

200 women with PPH will be randomly divided into 2 equal groups using computer generated random numbers. Group 1 will receive Ergometrine 400µgm (Methergin® Novartis, Switzerland) and group 2 will receive oxytocin 10 IU (Syntocinon®, 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.

Estado general Unknown status
Fecha de inicio November 2014
Fecha de finalización primaria October 2017
Fase Phase 3
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Need for other uterotonics 2 minutes after giving the drug
Resultado secundario
Medida Periodo de tiempo
Development of major PPH 10 minutes after giving the drug.
Inscripción 200
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Ergometrine

Descripción: 100 women with atonic PPH will receive Ergometrine 400µgm (Methergin® Novartis, Switzerland) slowly intravenous (iv).

Etiqueta de grupo de brazo: Ergometrine

Tipo de intervención: Drug

Nombre de intervención: Oxytocin

Descripción: 100 women with atonic PPH will receive Oxytocin 10 IU(Syntocinon® Novartis, Switzerland) slowly intravenous. iv and group 2 will receive oxytocin

Etiqueta de grupo de brazo: Oxytocin

Elegibilidad

Criterios:

Inclusion Criteria:

- Atonic PPH

Exclusion Criteria:

- Gestational age<37 weeks

- Hypertension, cardiac disease or preeclampsia

Género: Female

Edad mínima: 20 Years

Edad máxima: 40 Years

Voluntarios Saludables: No

Contacto general

Apellido: AbdelGany MA Hassan, MRCOG, MD

Teléfono: 00201017801604

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto:
BeniSuef University hospitals | BeniSuef, Egypt Recruiting Nesreen AA Shehata, MD +2001227866337 [email protected]
Cairo university hospitals | Cairo, Egypt Recruiting AbdelGany Hassan, MRCOG, MD 002 01017801604 [email protected] AbdelGany MA Hassan, MRCOG, MD Principal Investigator
Ubicacion Paises

Egypt

Fecha de verificación

January 2017

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Cairo University

Nombre completo del investigador: AbdelGany Hassan

Título del investigador: Lecturer of Gynecology and Obstetrics

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Ergometrine

Tipo: Active Comparator

Descripción: 100 women with atonic PPH will receive Ergometrine 400µgm (Methergin® Novartis, Switzerland) slowly intravenous (iv)

Etiqueta: Oxytocin

Tipo: Active Comparator

Descripción: 100 women with atonic PPH will receive oxytocin 10 IU (Syntocinon® Novartis, Switzerland) slowly intravenous.

Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Double (Participant, Investigator)

Fuente: ClinicalTrials.gov