Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery

Sublingual Misoprostol Versus Placebo to Reduce Blood Loss During Elective Cesarean Delivery : A Randomized Controlled Study

Patrocinadores

Patrocinador principal: Ain Shams Maternity Hospital

Fuente Ain Shams Maternity Hospital
Resumen breve

Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery : A Randomized Controlled Trial

Descripción detallada

This study aims to evaluate efficacy and safety of subligual misoprostol in reducing blood loss during cesarean section , a randomized double blinded prospective controlled trial conducted at Ain Shams maternity hospital . 158 women who fulfilled the inclusion criteria enrolled in this study .the patients randomized into two groups one of them will receive sublingual misoprostol 400 micrograms ( misotac )and the other will receive placebo( Ranitak ),all patients will subjected to history,physical examination,and investigations.preparation of patients (preload and antibiotics )according to hospital protocol.All C.S will be perfomed using spinal anaesthesia ,pfannenstiel incision of the skin ,open of abdomen in layers ,at cord clamping the patients will receive the medication sublingual and 20IU of oxytocin intravenous infusion simultaneous by the anesthesiologist,then close in anatomical layers.blood loss during C.S will be calculated following placental delivery to the end of surgery,and from the end of the operation to 6h after birth.the need for additional uterotonics agents,blood transfusion and adverse effects of the study drug will be recorded.

Estado general Unknown status
Fecha de inicio July 2016
Fecha de Terminación May 2017
Fecha de finalización primaria May 2017
Fase Phase 2
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Blood loss during cesarean sections through study completion, an average of 1 year
Resultado secundario
Medida Periodo de tiempo
Vaginal bleeding through study completion, an average of 1 year
Change in blood pressure and pulse through study completion, an average of 1 year
Blood loss after 24 hr. through study completion, an average of 1 year
Need for additional uterotonic agent through study completion, an average of 1 year
Need for blood transfusion through study completion, an average of 1 year
Need for surgical measures to stop bleeding through study completion, an average of 1 year
Side effects of misoprostol through study completion, an average of 1 year
Inscripción 158
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Misoprostol Oral Tablet

Descripción: at cord clamping the patient will recieve 400 micrograms of misoprostol sublingually

Etiqueta de grupo de brazo: Misoprostol oral tablets

Otro nombre: Misotac

Tipo de intervención: Drug

Nombre de intervención: Ranitidine Oral Tablet

Descripción: at cord clamping the patient will recieve ranitidine sublingually

Etiqueta de grupo de brazo: Ranitidine oral tablets

Otro nombre: Ranitak

Elegibilidad

Criterios:

Inclusion Criteria:

- singleton pregnancies

- women booked for elective C.S

- full term pregnancies

- primi gravida or previous one delivery ( either by spontaneous vaginal delivery or C.S )

Exclusion Criteria:

- blood disorders

- multiple pregnancy

- placenta previa

- polyhydramnios

- marked maternal anemia

- contraindications to prostaglandin e.g history of asthma , allergy to misoprostol

- previous 2 or more C.S

Género: Female

Edad mínima: 19 Years

Edad máxima: 35 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Apellido Papel Afiliación
Amr H YEHIA, MD,MRCOG Study Director Ain Shams University-Maternity Hospital
Contacto general

Apellido: Mohamed H Fathy, M.B.B.Ch

Teléfono: 00201099984100

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: Copia de seguridad de contactos: Ain shams maternity hospital Mohamed Fathy, M.B.B.Ch 00201099984100 [email protected]
Ubicacion Paises

Egypt

Fecha de verificación

May 2017

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Ain Shams Maternity Hospital

Nombre completo del investigador: Mohamed Fathy

Título del investigador: Resident of obstetrics and gynecology

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

Etiqueta: Misoprostol oral tablets

Tipo: Active Comparator

Descripción: 79 women will recieve 400 micrograms of misoprostol ( misotac) sublingually and 20 IU of oxytocin at cord clamping

Etiqueta: Ranitidine oral tablets

Tipo: Placebo Comparator

Descripción: 79 women will recieve ranitidine oral tablets sublingually and 20 IU of oxytocin at cord clamping

Datos del paciente Yes
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Double (Participant, Investigator)

Fuente: ClinicalTrials.gov