Bionic Balloon-assisted Delivery Technology on the Labor Process
ConditionVaginal Delivery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorPeking Union Medical College Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.;
Trial design
Design model
Parallel
Treatments tested in this trial
Bionic Balloon-assisted Delivery
DeviceBionic 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.
Routine Labor Management
Procedure/SurgeryRoutine 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.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Balloon GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
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.
Time frame
From onset of labor to delivery of the placenta.Secondary outcomes
1
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.
Time frame
During labor and delivery2
Incidence of Intrapartum Fever
Percentage of participants with body temperature greater than or equal to 38 degrees Celsius after the onset of labor.
Time frame
From onset of labor to delivery3
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.
Time frame
Within 24 hours after delivery4
Incidence of Postpartum Infection
Percentage of participants with postpartum infection requiring antibiotic treatment after delivery.
Time frame
From 24 hours to 48 hours after deliverySponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: