Bionic Balloon-assisted Delivery Technology on the Labor Process
Study on The Impact of Bionic Balloon-assisted Delivery Technology on the Labor Process and Maternal and Neonatal Outcomes
This multicenter, prospective, randomized controlled trial will evaluate the efficacy and safety of bionic balloon-assisted delivery technology in nulliparous women planning vaginal delivery. Eligible participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. Participants in the control group will receive routine labor management, while participants in the intervention group will receive bionic balloon-assisted delivery in addition to routine labor management after entering the active phase of labor.
The primary outcome is the duration of labor, including the first, second, and third stages of labor. Secondary outcomes include intrapartum cesarean conversion rate, intrapartum and postpartum complications, neonatal outcomes, postpartum pelvic floor dysfunction, postpartum depression, and maternal satisfaction. This study aims to determine whether bionic balloon-assisted delivery can shorten labor duration, reduce intrapartum cesarean conversion, and improve maternal and neonatal outcomes without increasing adverse events.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Bionic balloon-assisted delivery is a physical delivery-assistance technique designed to simulate the pressure and stimulation exerted by the fetal presenting part on the cervix and birth canal during labor. By providing controlled mechanical dilation of the upper and lower vagina during the active phase of labor, this technique may promote labor progress without the use of additional pharmacologic agents.
This study is a multicenter, prospective, randomized controlled trial designed to evaluate the efficacy and safety of bionic balloon-assisted delivery technology in nulliparous women planning vaginal delivery. Eligible participants will be women aged 18 to 45 years with singleton, term pregnancy, cephalic presentation, no contraindications to vaginal delivery, latent phase longer than 3 hours, cervical dilation greater than 4 to 5 centimeters indicating entry into the active phase of labor, fetal head engagement, and no obvious cephalopelvic disproportion. After written informed consent is obtained, participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group.
Participants in the control group will receive routine labor management for vaginal delivery. This includes close monitoring after the onset of labor, artificial rupture of membranes when cervical dilation reaches more than 4 to 5 centimeters and the fetal head is engaged, continued observation of uterine contractions, fetal heart rate, and amniotic fluid characteristics, and operative vaginal delivery or emergency cesarean section when clinically indicated.
Participants in the intervention group will receive bionic balloon-assisted delivery in addition to routine labor management. After the participant enters the active phase of labor and the fetal head is engaged, the KCB-II automatic bionic balloon-assisted delivery device will be used with a sterile latex balloon dilation handle. The balloon will be placed in the upper vagina near the fornix after artificial rupture of membranes and inflated according to the study protocol to mechanically dilate the birth canal. Other labor management procedures will follow routine clinical practice.
The primary outcome is the duration of labor, including the first, second, and third stages of labor. Secondary outcomes include intrapartum cesarean conversion rate; intrapartum and postpartum complications such as intrapartum fever, postpartum hemorrhage, postpartum infection, urinary retention, soft birth canal laceration, episiotomy, and operative vaginal delivery; neonatal outcomes including birth weight, Apgar scores, umbilical artery blood gas analysis results when available, neonatal complications, and admission to the neonatal intensive care unit; postpartum pelvic floor dysfunction; postpartum depression assessed using the Edinburgh Postnatal Depression Scale; and maternal satisfaction.
Participants will be followed through delivery, discharge, and the routine postpartum visit at 42 days after delivery. The study aims to determine whether bionic balloon-assisted delivery can shorten labor duration, reduce intrapartum cesarean conversion, and improve maternal and neonatal outcomes without increasing adverse events.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yifeng Zhong, Associate Professor
- Número de teléfono: +86 18612708860
- Correo electrónico: ZYFL1026@163.com
Ubicaciones de estudio
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Beijing, Porcelana
- Beijing Tongren Hospital
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Contacto:
- Yifeng Zhong
- Número de teléfono: +86 18612708860
- Correo electrónico: ZYFL1026@163.com
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Beijing, Porcelana
- Peking Union Medical College Hospital
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Contacto:
- Yifeng Zhong
- Número de teléfono: +86 18612708860
- Correo electrónico: ZYFL1026@163.com
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Beijing, Porcelana
- Beijing Obstetrics and Gynecology Hospital
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Contacto:
- Yifeng Zhong
- Número de teléfono: +86 18612708860
- Correo electrónico: ZYFL1026@163.com
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Hebei
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Cangzhou, Hebei, Porcelana
- Cangzhou Central Hospital
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Contacto:
- Yifeng Zhong
- Número de teléfono: +86 18612708860
- Correo electrónico: ZYFL1026@163.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age: 18-45 years;
- Nulliparous women with singleton, term pregnancy, cephalic presentation, and no contraindications to vaginal delivery;
- Latent phase longer than 3 hours, cervical dilation greater than 4-5 cm (entry into the active phase), fetal head engagement, and no obvious cephalopelvic disproportion;
- Voluntary participation in this study and signing of written informed consent.
Exclusion Criteria:
- Multiparous women;
- Non-cephalic presentation;
- Genital tract infection;
- High-risk pregnancy score classified as "red ball," "purple ball," or some "orange ball" categories, including severe medical or surgical comorbidities, placenta previa, scarred uterus, etc.;
- Presence of cephalopelvic disproportion, abnormal fetal heart rate, or other conditions unsuitable for vaginal delivery and requiring cesarean section;
- Other conditions considered unsuitable for enrollment by the clinician.
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: Balloon Group
Participants in this group will receive bionic balloon-assisted delivery in addition to routine labor management.
After entering the active phase of labor, when cervical dilation reaches 4-5 cm or more and the fetal head is engaged, bionic balloon-assisted delivery will be performed using the KCB-II automatic bionic balloon-assisted delivery device.
Other labor management procedures will follow routine clinical practice.
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Bionic balloon-assisted delivery will be performed using the KCB-II automatic bionic balloon-assisted delivery device with a sterile latex balloon dilation handle.
The balloon will be placed in the upper vagina near the fornix after artificial rupture of membranes and inflated according to the protocol to mechanically dilate the birth canal.
Routine labor management will also be provided.
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Comparador activo: Control Group
Participants in this group will receive routine labor management for vaginal delivery.
This includes close monitoring after the onset of labor, artificial rupture of membranes when cervical dilation reaches more than 4-5 cm and the fetal head is engaged, observation of uterine contractions, fetal heart rate, and amniotic fluid characteristics, and operative vaginal delivery or emergency cesarean section when clinically indicated.
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Routine labor management includes standard monitoring and clinical management during vaginal delivery, artificial rupture of membranes when indicated, continued observation of labor progress and fetal status, operative vaginal delivery when necessary, and emergency cesarean section if indications such as arrest of labor, cephalopelvic disproportion, or abnormal fetal heart rate occur.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Duration of Labor
Periodo de tiempo: From onset of labor to delivery of the placenta.
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The duration of labor will be measured, including the first, second, and third stages of labor.
The first stage of labor is defined as the period from the onset of labor to full cervical dilation; the second stage is defined as the period from full cervical dilation to delivery of the fetus; and the third stage is defined as the period from delivery of the fetus to delivery of the placenta.
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From onset of labor to delivery of the placenta.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Intrapartum Cesarean Conversion Rate
Periodo de tiempo: During labor and delivery
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The proportion of participants who undergo emergency cesarean section during trial of vaginal delivery due to indications such as arrest of labor, cephalopelvic disproportion, or abnormal fetal heart rate.
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During labor and delivery
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Incidence of Intrapartum Fever
Periodo de tiempo: From onset of labor to delivery
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Percentage of participants with body temperature greater than or equal to 38 degrees Celsius after the onset of labor.
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From onset of labor to delivery
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Incidence of Postpartum Hemorrhage
Periodo de tiempo: Within 24 hours after delivery
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Percentage of participants with postpartum hemorrhage, defined as blood loss of at least 500 milliliters after vaginal delivery or at least 1000 milliliters after cesarean delivery within 24 hours after delivery.
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Within 24 hours after delivery
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Incidence of Postpartum Infection
Periodo de tiempo: From 24 hours to 48 hours after delivery
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Percentage of participants with postpartum infection requiring antibiotic treatment after delivery.
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From 24 hours to 48 hours after delivery
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Incidence of Urinary Retention
Periodo de tiempo: From onset of labor to 48 hours after delivery
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Percentage of participants with intrapartum or postpartum urinary retention.
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From onset of labor to 48 hours after delivery
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Incidence of Soft Birth Canal Laceration
Periodo de tiempo: At delivery
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Percentage of participants with soft birth canal laceration after delivery.
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At delivery
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Incidence of Episiotomy
Periodo de tiempo: At delivery
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Percentage of participants who undergo episiotomy during vaginal delivery.
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At delivery
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Incidence of Operative Vaginal Delivery
Periodo de tiempo: At delivery
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Percentage of participants who undergo forceps-assisted or vacuum-assisted vaginal delivery.
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At delivery
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Neonatal Birth Weight
Periodo de tiempo: At birth
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Birth weight of the newborn.
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At birth
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Apgar Score at 1 Minute
Periodo de tiempo: 1 minute after birth
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Apgar score assessed 1 minute after birth.
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1 minute after birth
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Apgar Score at 5 Minutes
Periodo de tiempo: 5 minutes after birth
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Apgar score assessed 5 minutes after birth.
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5 minutes after birth
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Apgar Score at 10 Minutes
Periodo de tiempo: 10 minutes after birth
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Apgar score assessed 10 minutes after birth.
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10 minutes after birth
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Umbilical Artery Blood pH
Periodo de tiempo: At birth
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Umbilical artery blood pH value when available.
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At birth
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Admission to the Neonatal Intensive Care Unit
Periodo de tiempo: From birth to 48 hours after birth
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Percentage of newborns admitted to the neonatal intensive care unit.
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From birth to 48 hours after birth
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Incidence of Neonatal Infection
Periodo de tiempo: From birth to 48 hours after birth
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Percentage of newborns with neonatal infection.
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From birth to 48 hours after birth
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Incidence of Meconium Aspiration
Periodo de tiempo: From birth to 48 hours after birth
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Percentage of newborns with meconium aspiration.
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From birth to 48 hours after birth
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Incidence of Neonatal Hypoxia
Periodo de tiempo: From birth to 48 hours after birth
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Percentage of newborns with neonatal hypoxia.
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From birth to 48 hours after birth
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Incidence of Perinatal Death
Periodo de tiempo: From birth to 7 days after birth
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Percentage of perinatal deaths.
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From birth to 7 days after birth
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Maternal Satisfaction
Periodo de tiempo: 2-3 days postpartum before discharge
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Maternal satisfaction with the delivery process will be assessed using a patient satisfaction survey before discharge.
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2-3 days postpartum before discharge
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Incidence of Postpartum Pelvic Floor Dysfunction
Periodo de tiempo: 42 days postpartum
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Postpartum pelvic floor function will be assessed by routine pelvic floor evaluation, including pelvic floor quantitative electromyography, muscle tone, muscle fatigue, muscle strength, quality-of-life assessment, and pain assessment.
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42 days postpartum
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Incidence of Postpartum Depression
Periodo de tiempo: 42 days postpartum
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Postpartum depression will be assessed using the Edinburgh Postnatal Depression Scale according to routine clinical practice.
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42 days postpartum
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Yifeng Zhong, Associate Professor, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Publicaciones y enlaces útiles
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
- I-26PJ1429
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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