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Bionic Balloon-assisted Delivery Technology on the Labor Process

12 lipca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

300

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Yifeng Zhong, Associate Professor
  • Numer telefonu: +86 18612708860
  • E-mail: ZYFL1026@163.com

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Urządzenie: 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.
Aktywny 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.
Procedura: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Duration of Labor
Ramy czasowe: 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.

Miary wyników drugorzędnych

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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Peking Union Medical College Hospital

Śledczy

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

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

15 lipca 2026

Zakończenie podstawowe (Szacowany)

15 lipca 2027

Ukończenie studiów (Szacowany)

15 lipca 2027

Daty rejestracji na studia

Pierwszy przesłany

6 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

12 lipca 2026

Pierwszy wysłany (Rzeczywisty)

16 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

16 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

12 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • I-26PJ1429

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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