Bionic Balloon-assisted Delivery Technology on the Labor Process

NCT07707804 | Not Yet Recruiting

• 1 other identifier: I-26PJ1429
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Vaginal Delivery

Keywords

Bionic balloon-assisted delivery; Labor duration; Maternal outcomes; Neonatal outcomes

Outcome Measures

Primary Outcomes (1)

• Duration of Labor

  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.

  From onset of labor to delivery of the placenta.

Secondary Outcomes (21)

• Intrapartum Cesarean Conversion Rate

  During labor and delivery

• Incidence of Intrapartum Fever

  From onset of labor to delivery

• Incidence of Postpartum Hemorrhage

  Within 24 hours after delivery

• Incidence of Postpartum Infection

  From 24 hours to 48 hours after delivery

• Incidence of Urinary Retention

  From onset of labor to 48 hours after delivery

Study Arms (2)

Balloon Group

EXPERIMENTAL

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.

Device: Bionic Balloon-assisted Delivery

Control Group

ACTIVE COMPARATOR

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.

Procedure: Routine Labor Management

Interventions

Bionic Balloon-assisted Delivery DEVICE

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.

Balloon Group

Routine Labor Management PROCEDURE

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (4)

Cangzhou Central Hospital

Cangzhou, Hebei, China

Location

Beijing Obstetrics and Gynecology Hospital

Beijing, China

Location

Beijing Tongren Hospital

Beijing, China

Location

Peking Union Medical College Hospital

Beijing, China

Location

Related Publications (1)

• Zhang M, Xy Z. Clinical application of airbag bionic midwifery technology in vaginal delivery of pregnancy with scarred uterus. Afr J Reprod Health. 2024 Nov 30;28(11):78-84. doi: 10.29063/ajrh2024/v28i11.8.

  PMID: 39756009 BACKGROUND

Study Officials

• Yifeng Zhong, Associate Professor

  Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yifeng Zhong, Associate Professor

CONTACT

+86 18612708860; ZYFL1026@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: If there are other parties who are masked in the clinical trial besides those listed above, use this space to describe those parties.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a multicenter, prospective, randomized controlled trial using a parallel assignment model. Eligible participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. The intervention group will receive bionic balloon-assisted delivery in addition to routine labor management, while the control group will receive routine labor management alone. Outcomes will be compared between the two groups to evaluate the efficacy and safety of bionic balloon-assisted delivery technology.

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 16, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)