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Bionic Balloon-assisted Delivery Technology on the Labor Process

12. juli 2026 opdateret af: Yifeng Zhong, Peking Union Medical College Hospital

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

300

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Yifeng Zhong, Associate Professor
  • Telefonnummer: +86 18612708860
  • E-mail: ZYFL1026@163.com

Studiesteder

  • Kina
      • Beijing, Kina
        • Beijing Tongren Hospital
        • Kontakt:
      • Beijing, Kina
        • Peking Union Medical College Hospital
        • Kontakt:
      • Beijing, Kina
        • Beijing Obstetrics and Gynecology Hospital
        • Kontakt:
    • Hebei
      • Cangzhou, Hebei, Kina
        • Cangzhou Central Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: 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.
Aktiv komparator: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Duration of Labor
Tidsramme: 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.
From onset of labor to delivery of the placenta.

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Peking Union Medical College Hospital

Efterforskere

  • Ledende efterforsker: Yifeng Zhong, Associate Professor, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. juli 2026

Primær færdiggørelse (Anslået)

15. juli 2027

Studieafslutning (Anslået)

15. juli 2027

Datoer for studieregistrering

Først indsendt

6. juli 2026

Først indsendt, der opfyldte QC-kriterier

12. juli 2026

Først opslået (Faktiske)

16. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • I-26PJ1429

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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