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Bionic Balloon-assisted Delivery Technology on the Labor Process
Sponsor: Peking Union Medical College Hospital
Summary
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.
Official title: Study on The Impact of Bionic Balloon-assisted Delivery Technology on the Labor Process and Maternal and Neonatal Outcomes
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2026-07-15
Completion Date
2027-07-15
Last Updated
2026-07-16
Healthy Volunteers
No
Conditions
Interventions
Bionic Balloon-assisted Delivery
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.
Routine Labor Management
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.
Locations (4)
Cangzhou Central Hospital
Cangzhou, Hebei, China
Beijing Obstetrics and Gynecology Hospital
Beijing, China
Beijing Tongren Hospital
Beijing, China
Peking Union Medical College Hospital
Beijing, China