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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vaginal Delivery
• Intervention / Treatment: Device: Bionic Balloon-assisted Delivery; Procedure: Routine Labor Management

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yifeng Zhong, Associate Professor; Phone Number: +86 18612708860; Email: ZYFL1026@163.com

Study Locations

• China
  • Beijing, China
    • Beijing Tongren Hospital
    • Contact: Yifeng Zhong; Phone Number: +86 18612708860; Email: ZYFL1026@163.com
  • Beijing, China
    • Peking Union Medical College Hospital
    • Contact: Yifeng Zhong; Phone Number: +86 18612708860; Email: ZYFL1026@163.com
  • Beijing, China
    • Beijing Obstetrics and Gynecology Hospital
    • Contact: Yifeng Zhong; Phone Number: +86 18612708860; Email: ZYFL1026@163.com
  • Hebei
    • Cangzhou, Hebei, China
      • Cangzhou Central Hospital
      • Contact: Yifeng Zhong; Phone Number: +86 18612708860; Email: ZYFL1026@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: 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.
Active Comparator: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intrapartum Cesarean Conversion Rate	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.	During labor and delivery
Incidence of Intrapartum Fever	Percentage of participants with body temperature greater than or equal to 38 degrees Celsius after the onset of labor.	From onset of labor to delivery
Incidence of Postpartum Hemorrhage	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.	Within 24 hours after delivery
Incidence of Postpartum Infection	Percentage of participants with postpartum infection requiring antibiotic treatment after delivery.	From 24 hours to 48 hours after delivery
Incidence of Urinary Retention	Percentage of participants with intrapartum or postpartum urinary retention.	From onset of labor to 48 hours after delivery
Incidence of Soft Birth Canal Laceration	Percentage of participants with soft birth canal laceration after delivery.	At delivery
Incidence of Episiotomy	Percentage of participants who undergo episiotomy during vaginal delivery.	At delivery
Incidence of Operative Vaginal Delivery	Percentage of participants who undergo forceps-assisted or vacuum-assisted vaginal delivery.	At delivery
Neonatal Birth Weight	Birth weight of the newborn.	At birth
Apgar Score at 1 Minute	Apgar score assessed 1 minute after birth.	1 minute after birth
Apgar Score at 5 Minutes	Apgar score assessed 5 minutes after birth.	5 minutes after birth
Apgar Score at 10 Minutes	Apgar score assessed 10 minutes after birth.	10 minutes after birth
Umbilical Artery Blood pH	Umbilical artery blood pH value when available.	At birth
Admission to the Neonatal Intensive Care Unit	Percentage of newborns admitted to the neonatal intensive care unit.	From birth to 48 hours after birth
Incidence of Neonatal Infection	Percentage of newborns with neonatal infection.	From birth to 48 hours after birth
Incidence of Meconium Aspiration	Percentage of newborns with meconium aspiration.	From birth to 48 hours after birth
Incidence of Neonatal Hypoxia	Percentage of newborns with neonatal hypoxia.	From birth to 48 hours after birth
Incidence of Perinatal Death	Percentage of perinatal deaths.	From birth to 7 days after birth
Maternal Satisfaction	Maternal satisfaction with the delivery process will be assessed using a patient satisfaction survey before discharge.	2-3 days postpartum before discharge
Incidence of Postpartum Pelvic Floor Dysfunction	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.	42 days postpartum
Incidence of Postpartum Depression	Postpartum depression will be assessed using the Edinburgh Postnatal Depression Scale according to routine clinical practice.	42 days postpartum

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Yifeng Zhong, Associate Professor, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 15, 2027

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 12, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 12, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Maternal outcomes; Labor duration; Neonatal outcomes; Bionic balloon-assisted delivery
• Other Study ID Numbers: I-26PJ1429

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared publicly due to participant privacy and confidentiality considerations. De-identified aggregate results may be reported in scientific publications or presentations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No