Combined Misoprostol and Cervical Balloon vs Misoprostol Alone for Induction on the First Day in Primiparas
Efficacy of Intravaginal Misoprostol Combined With Cervical Balloon Versus Misoprostol Alone for Induction of Labor on the First Day in Primiparous Women: A Randomized Controlled Trial
Misoprostol (a prostaglandin E1 analog) is commonly used for cervical ripening and labor induction via vaginal administration. The cervical balloon is another commonly used method that provides mechanical cervical dilation. Both methods are low-cost and widely available. Some meta-analyses have suggested that combined use may shorten the duration of labor, reduce the frequency of tachysystole, and lower NICU admission rates without increasing the risk of cesarean section. However, existing studies are heterogeneous and lack data from Asian populations.
This study is being done to see whether combining two common methods of labor induction-misoprostol (a medicine placed in the vagina) and a cervical balloon (placed in the cervix) on the first day of induction-can shorten the time from the start of induction to delivery in first-time mothers during pregnancy .
Participants will be randomly assigned to one of two groups: one group will receive misoprostol alone (standard care) on the first day of induction, and the other group will receive misoprostol plus a cervical balloon on the first day of induction. The main outcome measured is the time from the start of induction to delivery. The study will also look at safety outcomes, including the rate of cesarean section, maternal complications, and newborn outcomes.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a single-center, randomized, open-label, superiority randomized controlled trial. Participants will be randomly assigned in a 1:1 ratio to either the intervention group (misoprostol plus cervical balloon on the first day of induction) or the control group (misoprostol alone on the first day of induction).
IPRIMARY OUTCOME:
Time from initiation of labor induction to delivery (hours).
SECONDARY OUTCOMES:
Time from induction to amniotomy (min), time from induction to spontaneous membrane rupture (h), time from induction to onset of labor (min), duration of balloon use (min), duration of oxytocin use (min), duration of latent phase (h), duration of first and second stages of labor (min), mode of delivery, degree of perineal laceration, indications for forceps/episiotomy/cesarean section, fetal distress, intrauterine infection, neonatal outcomes (birth weight, Apgar score, umbilical artery pH/BE, NICU admission), and maternal hemoglobin difference before and after delivery. Safety outcomes include placental abruption, septic shock, and severe postpartum hemorrhage.
SAMPLE SIZE:
Based on historical data from 90 primiparous women at Peking University First Hospital (June 2025), the mean induction-to-delivery interval was 39.07 ± 19.92 hours. Assuming an 8-hour reduction in the intervention group, with a two-sided alpha of 0.05, power of 80%, and a 10% dropout rate, each group requires 110 participants (total 220).
STATISTICAL ANALYSIS:
Continuous variables will be compared using t-test or Mann-Whitney U test as appropriate. Categorical variables will be compared using chi-square or Fisher's exact test. Multivariable linear regression and logistic regression will be used for adjusted analyses. Subgroup analyses will be performed by type of hyperglycemia, age, BMI, and baseline Bishop score.
ETHICS AND REGISTRATION:
This study has been approved by the Biomedical Research Ethics Committee of Peking University First Hospital (Approval No. 2025R0393-0002, dated September 25, 2025). The study is registered on ClinicalTrials.gov.
STUDY PERIOD:
June 2026 to December 2026.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 4
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ye Feng, M.D.
- Número de teléfono: 8618001203634
- Correo electrónico: fengye_bjmu@163.com
Copia de seguridad de contactos de estudio
- Nombre: Jianhua Niu, M.D.
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age 20-45 years at delivery
- Singleton pregnancy
- Primiparous
- Cephalic presentation
- Cervical Bishop score ≤ 5
- No history of stillbirth
Exclusion Criteria:
- Multiple pregnancy
- Contraindications to vaginal delivery
- Mental disorders (depression or anxiety)
- Preterm labor (< 37 weeks)
- Intrauterine fetal death
- Previous uterine surgery
- Premature rupture of membranes
- Abnormal fetal heart rate tracing
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: Misoprostol Plus Cervical Balloon
Participants receive 25 μg misoprostol placed in the posterior vaginal fornix, combined with a Cervical balloon catheter (80 mL inflation) placed intracervically for 12-24 hours on the first day of induction.
Misoprostol may be repeated up to 3-4 times based on uterine contraction response.
|
A Cervical balloon with 80 mL sterile water inflation placed intracervically for mechanical cervical dilation.
The balloon is left in place for up to 12-24 hours or until spontaneous expulsion.
|
|
Comparador activo: Misoprostol Alone
Participants receive 25 μg misoprostol placed in the posterior vaginal fornix alone on the first day of induction.
Misoprostol may be repeated up to 3-4 times based on uterine contraction response.
|
25 μg misoprostol tablet placed in the posterior vaginal fornix for cervical ripening and labor induction on the first day.
May be repeated up to 3-4 times based on uterine contraction response (monitored every 2-4 hours).
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time from initiation of labor induction to delivery
Periodo de tiempo: Time from initiation of induction measures on the first day of induction to delivery (control group: time of first misoprostol placement; intervention group: time of cervical balloon and misoprostol placement).
|
Time in hours from the start of labor induction (placement of first dose of misoprostol or Foley balloon) to vaginal delivery or cesarean section.
|
Time from initiation of induction measures on the first day of induction to delivery (control group: time of first misoprostol placement; intervention group: time of cervical balloon and misoprostol placement).
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time from Induction to Amniotomy
Periodo de tiempo: From start of induction to amniotomy
|
Duration from the start of induction (placement of misoprostol or balloon+misoprostol) to the performance of amniotomy, measured in minutes.
|
From start of induction to amniotomy
|
|
Time from Induction to Spontaneous Membrane Rupture
Periodo de tiempo: From start of induction to spontaneous rupture
|
Duration from the start of induction to spontaneous rupture of fetal membranes, measured in hours.
|
From start of induction to spontaneous rupture
|
|
Time from Induction to Onset of Labor
Periodo de tiempo: From start of induction to onset of labor
|
Duration from the start of induction to the establishment of regular painful uterine contractions with cervical opening, measured in minutes.
|
From start of induction to onset of labor
|
|
Duration of Balloon Use
Periodo de tiempo: From balloon insertion to removal, assessed during the induction period (up to 24 hours).
|
Total time the cervical balloon remains in place (from insertion to removal), measured in minutes.
|
From balloon insertion to removal, assessed during the induction period (up to 24 hours).
|
|
Duration of Oxytocin Use
Periodo de tiempo: From start to stop of oxytocin infusion, assessed during labor
|
Total duration of oxytocin administration during labor, measured in minutes.
|
From start to stop of oxytocin infusion, assessed during labor
|
|
Duration of Latent Phase of Labor
Periodo de tiempo: From onset of labor to active phase, assessed during labor
|
Time from onset of labor to cervical dilation of 5 cm, measured in hours.
|
From onset of labor to active phase, assessed during labor
|
|
Duration of First and Second Stages of Labor
Periodo de tiempo: From full dilation to delivery, assessed during the second stage
|
Time from full cervical dilation (first stage) to delivery of the newborn (second stage), measured in minutes
|
From full dilation to delivery, assessed during the second stage
|
|
Mode of Delivery
Periodo de tiempo: At the time of delivery.
|
Categorization of delivery as spontaneous vaginal, vacuum/forceps-assisted, or cesarean section.
|
At the time of delivery.
|
|
Degree of Perineal Laceration
Periodo de tiempo: Immediately after vaginal delivery.
|
Severity of perineal tears classified as first-, second-, third-, or fourth-degree.
|
Immediately after vaginal delivery.
|
|
Indications for Forceps/Episiotomy/Cesarean Section
Periodo de tiempo: At the time of the operative intervention (during labor/delivery).
|
Clinical reasons for performing forceps delivery, episiotomy, or cesarean section (e.g., fetal distress, arrest of labor).
|
At the time of the operative intervention (during labor/delivery).
|
|
Fetal Distress
Periodo de tiempo: During labor, assessed up to delivery.
|
Presence of fetal distress diagnosed by abnormal fetal heart rate patterns or acidemia during labor.
|
During labor, assessed up to delivery.
|
|
Intrauterine Infection
Periodo de tiempo: During labor and up to 48 hours postpartum.
|
Clinical or histologic diagnosis of chorioamnionitis or endometritis during or after delivery.
|
During labor and up to 48 hours postpartum.
|
|
Neonatal Birth Weight
Periodo de tiempo: At delivery (immediately after birth).
|
Weight of the newborn measured immediately after delivery, in grams.
|
At delivery (immediately after birth).
|
|
Apgar Score
Periodo de tiempo: At 1 and 5 minutes after birth.
|
Apgar score assessed at 1 and 5 minutes after birth, range 0-10.
|
At 1 and 5 minutes after birth.
|
|
Umbilical Artery pH and Base Excess
Periodo de tiempo: Immediately after delivery (from cord blood).
|
pH and base excess (BE) values measured in umbilical artery blood at delivery.
|
Immediately after delivery (from cord blood).
|
|
NICU Admission
Periodo de tiempo: After birth.
|
Whether the newborn is admitted to the NICU after delivery.
|
After birth.
|
|
Maternal Hemoglobin Difference
Periodo de tiempo: Baseline (before induction) and within 24-48 hours after delivery.
|
Difference between pre-delivery (baseline) and post-delivery hemoglobin levels, measured in g/dL.
|
Baseline (before induction) and within 24-48 hours after delivery.
|
|
Placental Abruption
Periodo de tiempo: During labor and delivery
|
Premature separation of the placenta from the uterine wall, diagnosed clinically or by ultrasound.
|
During labor and delivery
|
|
Septic Shock
Periodo de tiempo: Before or after birth
|
Severe infection leading to circulatory failure, requiring vasopressors.
|
Before or after birth
|
|
Severe Postpartum Hemorrhage
Periodo de tiempo: Within 24 hours after delivery.
|
Estimated blood loss ≥1000 mL or requiring transfusion or surgical intervention.
|
Within 24 hours after delivery.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ye Feng, M.D., Peking University First Hospital
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025R0393-0002
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. .