The Effect of Primary Cesarean Section Prevention on Maternal and Neonatal Outcomes
The study aimed to examine the effect of prolonging the second stage of labor on the rate of Cesarean section (CS), maternal and neonatal outcomes.
The study compared 2 time periods. The first time period was between May 2011 until April 2014 when a prolonged second stage in nulliparous women was considered three hours with regional anesthesia or two hours if no such anesthesia was provided. Second stage arrest was defined in multiparous women after two hours with regional anesthesia or one hour without it. The second time period was between May 2014 until April 2017, allowed nulliparous and multiparous women to continue the second stage of labor an additional one hour before diagnosing second-stage arrest. Singleton deliveries at or beyond 37 weeks' gestation were initially considered for eligibility.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The study aimed to examine the effect of prolonging the second stage of labor on the rate of Cesarean section (CS), maternal and neonatal outcomes.
The study compared 2 time periods. The first time period was between May 2011 until April 2014 when a prolonged second stage in nulliparous women was considered three hours with regional anesthesia or two hours if no such anesthesia was provided. Second stage arrest was defined in multiparous women after two hours with regional anesthesia or one hour without it. The second time period was between May 2014 until April 2017, allowed nulliparous and multiparous women to continue the second stage of labor an additional one hour before diagnosing second-stage arrest. Singleton deliveries at or beyond 37 weeks' gestation were initially considered for eligibility.
The rate of CS, operative vaginal deliveries, 3rd and 4th degree lacerations, postpartum hemorrhage, arterial cord PH below 7 and admissions to the neonatal intensive care unit (NICU).
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Haifa, Israel
- Rambam Health Care Campus
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
1. Singleton deliveries at or beyond 37 weeks' gestation.
Exclusion Criteria:
- Non-vertex presentation.
- Trial of labor after CS.
- High risk pregnancy (multiple gestation, preeclampsia, diabetes mellitus, intrauterine growth restriction).
- Known fetal anomalies and intrauterine fetal demise.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Prolonged second stage of labor
Women with prolonged second stage of labor as specified before.
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To examine the effect of prolonging the second stage of labor on the rate of cesarean delivery, maternal and neonatal outcomes
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The rate of primary CS.
Periodo de tiempo: Between 2011 and 2017.
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The rate of primary CS in percentage of the total participants.
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Between 2011 and 2017.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The rate of operative vaginal delivery.
Periodo de tiempo: Between 2011 and 2017.
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The rate of operative vaginal delivery in percentage of the total participants.
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Between 2011 and 2017.
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Post-partum hemorrhage.
Periodo de tiempo: Between 2011 and 2017.
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Post-partum hemorrhage as estimated in liters.
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Between 2011 and 2017.
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The need for blood transfusion.
Periodo de tiempo: Between 2011 and 2017.
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Number and type of blood products required post-partum and calculation of the number of patients that required blood products out of the total number of participants in percentage.
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Between 2011 and 2017.
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Third-and fourth-degree laceration rate.
Periodo de tiempo: Between 2011 and 2017.
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Third-and fourth-degree laceration rate of the total number of participants.
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Between 2011 and 2017.
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Chorioamnionitis rate.
Periodo de tiempo: Between 2011 and 2017.
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Chorioamnionitis rate in percentage of the total participants.
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Between 2011 and 2017.
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Admission to the NICU.
Periodo de tiempo: Between 2011 and 2017.
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Admission to the NICU in percentage of the total participants.
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Between 2011 and 2017.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Kamel Mattar, MD, Principal Investigator
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
Otros números de identificación del estudio
- 0258-17-RMB
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.
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