Tearing of Membranes Before Birth - a Comparison Between Two Ways of Induction of Labor Pitocin Opposite Prostaglandin
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Premature rupture of membranes (PROM) is a common occurrence that occurs in the incidence of 8-10% of births. Since the duration until delivery is important in avoiding the risk of complications, several studies have been performed in order to understand what is the preferred way to manage this condition of PROM in women that are not in active labor. In the largest random study that has been performed 20 years ago, there was found an advantage for labor induction with oxytocin over labor induction with Prostaglandin or waiting. However, the most important component - the BISHOP score, that affects the decision of the labor induction way, was not reported and was not taken into consideration.
Therefore, the aim of the study is to compare randomly the perinatal outcomes in women with PROM and low BISHOP between women who undergo labor induction with Oxytocin and women who undergo labor induction with Prostaglandin E2.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 3
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- rupture of membranes in BISHOP score lower than 7.
- Pregnancy week 34+0 and onward.
- Singleton pregnancy.
- Verifying fetal monitoring.
- Normal maternal temperature (lower than 37.8)
- Without vaginal bleeding or suspected placental separation
- Contractions in frequency of less than 3 in 10 minutes
- Signed consent form.
Exclusion Criteria:
- Multiple pregnancy.
- Maternal age below 18 or over 42.
- Active labor
- Contractions in frequency of more than 3 in 10 minutes or cervical dilation ≥2 cm.
- Lack of consent to participate in the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intravenous oxytocin
Women that arrive to women's ER and diagnosed with rupture of membranes in week 34+0 and onward, are not in active labor and with Bishop score lower than 7. Those who agreed to participate in the study after signing an informed consent form will undergo the following steps:
|
Intravenous oxytocin chosen randomly. we will collect basic and obstetric data, laboratory results and physical examination, monitoring and sonar. Induction according to departmental protocol of each delivery way. Data collecting after the delivery. |
|
Experimental: vaginal prostaglandin
Women that arrive to women's ER and diagnosed with rupture of membranes in week 34+0 and onward, are not in active labor and with Bishop score lower than 7. Those who agreed to participate in the study after signing an informed consent form will undergo the following steps:
|
Vaginal prostaglandin chosen randomly. we will collect basic and obstetric data, laboratory results and physical examination, monitoring and sonar. Induction according to departmental protocol of each delivery way. Data collecting after the delivery. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
The duration from the beginning of labor induction until delivery
Periodo de tiempo: 5 days
|
5 days
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Duration of labor induction from rupture of membranes until delivery.
Periodo de tiempo: 5 days
|
5 days
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sharon Maslovitz, MD, Tel Aviv Medical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 0073-15-TLV
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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