Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Bionic Balloon-assisted Delivery Technology on the Labor Process

12. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

300

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

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

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Gerät: 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.
Aktiver 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.
Verfahren: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Duration of Labor
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Intrapartum Cesarean Conversion Rate
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: At delivery
Percentage of participants with soft birth canal laceration after delivery.
At delivery
Incidence of Episiotomy
Zeitfenster: At delivery
Percentage of participants who undergo episiotomy during vaginal delivery.
At delivery
Incidence of Operative Vaginal Delivery
Zeitfenster: At delivery
Percentage of participants who undergo forceps-assisted or vacuum-assisted vaginal delivery.
At delivery
Neonatal Birth Weight
Zeitfenster: At birth
Birth weight of the newborn.
At birth
Apgar Score at 1 Minute
Zeitfenster: 1 minute after birth
Apgar score assessed 1 minute after birth.
1 minute after birth
Apgar Score at 5 Minutes
Zeitfenster: 5 minutes after birth
Apgar score assessed 5 minutes after birth.
5 minutes after birth
Apgar Score at 10 Minutes
Zeitfenster: 10 minutes after birth
Apgar score assessed 10 minutes after birth.
10 minutes after birth
Umbilical Artery Blood pH
Zeitfenster: At birth
Umbilical artery blood pH value when available.
At birth
Admission to the Neonatal Intensive Care Unit
Zeitfenster: 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
Zeitfenster: From birth to 48 hours after birth
Percentage of newborns with neonatal infection.
From birth to 48 hours after birth
Incidence of Meconium Aspiration
Zeitfenster: From birth to 48 hours after birth
Percentage of newborns with meconium aspiration.
From birth to 48 hours after birth
Incidence of Neonatal Hypoxia
Zeitfenster: From birth to 48 hours after birth
Percentage of newborns with neonatal hypoxia.
From birth to 48 hours after birth
Incidence of Perinatal Death
Zeitfenster: From birth to 7 days after birth
Percentage of perinatal deaths.
From birth to 7 days after birth
Maternal Satisfaction
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 42 days postpartum
Postpartum depression will be assessed using the Edinburgh Postnatal Depression Scale according to routine clinical practice.
42 days postpartum

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Peking Union Medical College Hospital

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. Juli 2026

Primärer Abschluss (Geschätzt)

15. Juli 2027

Studienabschluss (Geschätzt)

15. Juli 2027

Studienanmeldedaten

Zuerst eingereicht

6. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. Juli 2026

Zuerst gepostet (Tatsächlich)

16. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • I-26PJ1429

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Vaginale Entbindung

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Georgia

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

3
Abonnieren