- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04193345
The Impact of Early Versus Delayed Umbilical Cord Clamping in Preeclamptic Pregnant Patients During Cesarean Section
The Maternal and Neonatal Impact of Early Versus Delayed Umbilical Cord Clamping Among Pregnant Severe Preeclampsia Patients Delivered by Cesarean Section
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The study will include 62 pregnant women attending for severe preeclampsia and cesarean delivery will be done at the Kasr Elaini hospital (faculty of medicine - Cairo university).
Informed written consent: after discussing the nature of the study as well as the expected value, outcome, and possible adverse effects.
Full medical history: including full obstetric history and current pregnancy history (entailing the 1st day of LMP).
Thorough Clinical Examination: general (maternal body weight and vital signs) and full obstetric examination.
Obstetric ultrasonography: to confirm gestational age and the eligibility of the current pregnancy to participate in the study.
Preoperative laboratory tests: including prothrombin time, prothrombin concentration, complete blood count, and liver and kidney function tests.
Group allocation: On the day of the scheduled surgery, participants will be randomly and equally assigned into two groups; early clamping group n= 31 ( umbilical cord to be clamped within 15 s ) and delayed clamping group , n= 31 ( umbilical cord to be clamped at 60 sec ) , In all groups , Neonates will be held in a sterile towel or blanket below the level of the incision on maternal abdomen or between her legs at cesarean section. Care was taken that no tension or traction was placed on the cord. A stopwatch was used to mark the time , patients will receive an intravenous bolus of 5 IU oxytocin (Syntocinon, Novartis, Basel, Switzerland) and 20 IU oxytocin in 500 mL lactated Ringer's solution (infused at a rate of 125 mL/h) following the delivery of the baby All cesarean sections will be done under spinal anesthesia by an assistant lecturer and the following operative steps: pfannenstiel incision, transverse lower uterine segment incision, early cord clamping (< 15 seconds) or delayed cord clamping (after 60 sec) and the placenta will be removed by controlled cord traction after its spontaneous separation, closure of uterus in 2 layers, closure of anterior abdominal wall in anatomical manner (adequate hemostasis will be ensured in all operative steps).
The number and the difference of weight of operative towels (before and after LSCS) and amount of blood in suction unit will be recorded.
A complete blood count test will be performed 12 hours after delivery. neonatal laboratory results (hemoglobin and hematocrit, )will be collected within 4 hours of age, initial serum bilirubin was collected at 12 hours of age then to be repeated at day 3 for follow up.
Estimated Blood Loss (EBL) will be evaluated as follows:
A. The number of operative towels used. B. The difference of weight of operative towels (before and after cs) plus the amount of blood in suction unit (we will calculate 1 gram of weight difference equal to 1 ml blood loss).
C. EBL calculation according to the following formula:
EBL= EBV x Preoperative hematocrit- Postoperative hematocrit Postoperative hematocrit Where EBV is estimated blood volume of the patient in mL (equals weight in kg × 85).
The neonates clinical data, as APGAR Score, blood pressure, temperature, jaundice, pallor and cyanosis and respiratory distress syndrome will be collected by the attending neonatologist .All patients will be followed up following the delivery as regard occurrence of primary postpartum hemorrhage (within the first 24 hours), the need for blood transfusion (within the first 24 hours).
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Cairo, Egipto
- faculty of medicine - Cairo university
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Pregnant women candidate for LSCS.
- Age: 20-40 years old.
- Maternal severe preeclampsia
- CS under spinal anesthesia.
- Singleton pregnancy
Exclusion Criteria:
- Fetal death (IUFD).
- Intrapartum surgical complications ( uterine artery injury or lower segment extension)
- Medical disorders such as Diabetes mellitus or severe anemia
- The need for immediate resuscitation like meconium aspiration .
- Abnormal placentation or placental abruption
- Liquor abnormalities ; oligo hydramnios
- Anomalous fetus
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Early cord clamping
The umbilical cord will be clamped within 15 seconds from delivery of the baby
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Comparing and monitoring the maternal blood loss and neonatal effect of delayed umbilical cord clamping and early umbilical cord clamping after delivery of the baby durin cesarean delivery in severe preeclampsia
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Comparador activo: Delayed cord clamping
The umbilical cord will be clamped after 60 seconds from delivery of the baby
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Comparing and monitoring the maternal blood loss and neonatal effect of delayed umbilical cord clamping and early umbilical cord clamping after delivery of the baby durin cesarean delivery in severe preeclampsia
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
the intra operative maternal blood loss
Periodo de tiempo: 24 hours
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To compare the early versus of delayed cord clamping on intra operative blood loss in pregnant patients diagnosed with severe preeclampsia
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24 hours
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
the neonatal outcome
Periodo de tiempo: 4 days
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To compare the neonatal benefit from delayed cord clamping group versus early clamping in patients with severe preeclampsia during cesarean delivery
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4 days
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The incidence of post partum hemorrhage
Periodo de tiempo: 24 hours
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To assess the extra need for ecbolics and the actual incidence of post partum hge with both methods
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24 hours
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- MD-74-2019
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Umbilical Cord Clamping
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Fundació Institut de Recerca de l'Hospital de la...Desconocido
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Medstar Health Research InstituteTerminadoCordón umbilicalEstados Unidos
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University Tunis El ManarTerminado
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Anchora MedicalReclutamientoHernia umbilical primariaIsrael, Eslovenia
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Institut Universitari DexeusReclutamientoSangre del cordón umbilicalEspaña
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Alexandria UniversityTerminadoOrdeño del cordón umbilicalEgipto
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University of NottinghamTerminadoPinzamiento diferido del cordón umbilicalReino Unido
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Sohag UniversityAún no reclutandoCordón umbilical de parto normalEgipto
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Antalya Training and Research HospitalTerminadoAnestesia General | Anestesia Espinal | Cordón umbilicalPavo
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University Hospital PadovaTerminadoCesárea electiva | Manejo del cordón umbilicalItalia