Bionic Balloon-assisted Delivery Technology on the Labor Process

NCT07707804 · tracked via the Priya Life Science China tracker

Sponsor

Peking Union Medical College Hospital

Phase

Not applicable

Started

2026-07-15

Last updated

2026-07-16

Condition(s) studied

Vaginal Delivery

Investigational drug(s) / intervention(s)

Bionic Balloon-assisted DeliveryRoutine Labor Management

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.

Study 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.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

45 Years

Healthy volunteers

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.

Primary outcome measure(s)

Duration of Labor — From onset of labor to delivery of the placenta.
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.

Trial sites (4)

Facility	City	Region
Cangzhou Central Hospital	Cangzhou	Hebei
Beijing Obstetrics and Gynecology Hospital	Beijing	China
Beijing Tongren Hospital	Beijing	China
Peking Union Medical College Hospital	Beijing	China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07707804 on ClinicalTrials.gov ↗ ← All trials in China