- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07821099
Outcome of Concurrent Versus Sequential Method of Induction of Labour in Term Pregnancy
Outcome of Concurrent Versus Sequential Method of Induction of Labour in Term Pregnancy: A Randomized Controlled Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Induction of labour is commonly performed when continuation of pregnancy is considered less beneficial than delivery. This randomized controlled trial will compare the effectiveness and safety of two approaches to cervical ripening and induction of labour in women with term pregnancy.
Eligible participants will have a gestational age of 37-42 weeks and will be admitted to the hospital for induction of labour without significant comorbidities. Gestational age will be confirmed using a dating scan or last menstrual period, and baseline fetal monitoring will be performed using cardiotocography (CTG) before induction.
Participants will be randomly allocated to one of two treatment groups.
In the concurrent group, a PGE2 vaginal pessary and a Foley catheter will be inserted concurrently. The Foley catheter balloon will be inflated with 30 mL of normal saline.
In the sequential group, the Foley catheter will be inserted first, followed by insertion of the PGE2 vaginal pessary 12 hours later.
The study will primarily assess the rate of vaginal delivery within 24 hours of initiation of induction. The study will also assess the overall effectiveness and safety of the two induction approaches, including the induction-to-delivery interval and relevant maternal and fetal complications.
Potential complications associated with induction of labour include failure of induction, uterine hyperstimulation, fetal distress or abnormal CTG, meconium-stained liquor, postpartum haemorrhage, uterine rupture, and chorioamnionitis. Participants will be continuously monitored during the induction process so that appropriate clinical management can be provided if complications occur.
The findings of this study may contribute to the development of safe, effective, and patient-centred induction-of-labour protocols, particularly in resource-constrained healthcare settings.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Shahzadi Saima Hussain, MHR
- Número de teléfono: +923337111981
- Correo electrónico: saima.hussain@lrh.edu.pk
Copia de seguridad de contactos de estudio
- Nombre: Dr Jawad Khan, PhD
- Número de teléfono: +92 334 9011681
- Correo electrónico: mdrjawad@yahoo.com
Ubicaciones de estudio
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KPK
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Peshawar, KPK, Pakistán, 25000
- Lady Reading Hospital
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Contacto:
- Dr Jawad Khan, PhD
- Número de teléfono: +92 334 9011681
- Correo electrónico: mdrjawad@yahoo.com
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Contacto:
- Shezadi Saima Hussain, MHR
- Número de teléfono: +92 333 7111981
- Correo electrónico: saima.hussain@lrh.edu.pk
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Pregnant women aged 18-40 years with a singleton cephalic fetus between 37 and 42 weeks of gestation who require induction of labour, with BMI 20-35 kg/m², intact membranes, and reassuring cardiotocography (CTG), will be included.
Exclusion Criteria:
- Women with meconium-stained liquor, antepartum haemorrhage, low-lying placenta defined as placental edge less than 2 cm from the internal os on ultrasonography, pre-eclampsia, fetal growth restriction, previously scarred uterus, estimated fetal weight greater than 4 kg on ultrasound, cephalopelvic disproportion, or liquor abnormalities will be excluded.
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 |
|---|---|
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Experimental: Concurrent Induction of Labour
Participants will receive concurrent cervical ripening with a PGE2 vaginal pessary and insertion of a Foley catheter.
The Foley catheter balloon will be inflated with 30 mL of normal saline.
Both interventions will be initiated concurrently at the start of induction of labour.
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A Foley catheter will be used for mechanical cervical ripening.
The balloon will be inflated with 30 mL of normal saline.
A PGE2 vaginal pessary will be used as a pharmacological method of cervical ripening during induction of labour.
|
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Comparador activo: Sequential Induction of Labour
Participants will receive sequential cervical ripening with a Foley catheter followed by insertion of a PGE2 vaginal pessary 12 hours later.
The Foley catheter will be inserted first, followed by the PGE2 vaginal pessary after 12 hours.
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A Foley catheter will be used for mechanical cervical ripening.
The balloon will be inflated with 30 mL of normal saline.
A PGE2 vaginal pessary will be used as a pharmacological method of cervical ripening during induction of labour.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Time from initiation of induction of labour to vaginal delivery
Periodo de tiempo: From initiation of induction of labour until vaginal delivery, up to 24 hours
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Time interval from the initiation of cervical ripening intervention to vaginal delivery, measured in hours.
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From initiation of induction of labour until vaginal delivery, up to 24 hours
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Successful vaginal delivery
Periodo de tiempo: From initiation of induction of labour until delivery, up to 24 hours
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Proportion of participants who achieve vaginal delivery following induction of labour.
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From initiation of induction of labour until delivery, up to 24 hours
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Shahzadi Saima Hussain, MHR, Khyber Medical University Peshawar, Pakistan
- Director de estudio: Dr Jawad Khan, PhD, Khyber Medical University Peshawar, Pakistan
- Investigador principal: Dr Mehnaz Faisal, MHPE, FCPS, Lady Reading Hospital Peshawar
Publicaciones y enlaces útiles
Publicaciones Generales
- Jozwiak M, Bloemenkamp KW, Kelly AJ, Mol BW, Irion O, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2012 Mar 14;(3):CD001233. doi: 10.1002/14651858.CD001233.pub2.
- Carbone JF, Tuuli MG, Fogertey PJ, Roehl KA, Macones GA. Combination of Foley bulb and vaginal misoprostol compared with vaginal misoprostol alone for cervical ripening and labor induction: a randomized controlled trial. Obstet Gynecol. 2013 Feb;121(2 Pt 1):247-252. doi: 10.1097/AOG.0b013e31827e5dca.
- de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2019 Oct 18;10(10):CD001233. doi: 10.1002/14651858.CD001233.pub3.
- Eser A, Ozkaya E, Abide CY, Eser T, Eser GY, Abike F, Tayyar AT, Eroglu M. Transcervical Foley balloon catheter and vaginal prostaglandin E2 insert combination vs. vaginal prostaglandin E2 insert only for induction of labor at term: a randomized clinical trial. Arch Gynecol Obstet. 2019 Feb;299(2):451-457. doi: 10.1007/s00404-018-4998-8. Epub 2018 Dec 7.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
- KMU/DIR/CTU/2026/12
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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