Vaginal Delivery
Conditions
Keywords
Bionic balloon-assisted delivery, Labor duration, Maternal outcomes, Neonatal outcomes
Brief summary
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.
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.
Interventions
DEVICEBionic 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.
PROCEDURERoutine 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.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
If there are other parties who are masked in the clinical trial besides those listed above, use this space to describe those parties.
Intervention model description
This is a multicenter, prospective, randomized controlled trial using a parallel assignment model. Eligible participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. The intervention group will receive bionic balloon-assisted delivery in addition to routine labor management, while the control group will receive routine labor management alone. Outcomes will be compared between the two groups to evaluate the efficacy and safety of bionic balloon-assisted delivery technology.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Labor | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intrapartum Cesarean Conversion Rate | 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. |
| Incidence of Intrapartum Fever | 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. |
| Incidence of Postpartum Hemorrhage | 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. |
| Incidence of Postpartum Infection | From 24 hours to 48 hours after delivery | Percentage of participants with postpartum infection requiring antibiotic treatment after delivery. |
| Incidence of Urinary Retention | From onset of labor to 48 hours after delivery | Percentage of participants with intrapartum or postpartum urinary retention. |
| Incidence of Soft Birth Canal Laceration | At delivery | Percentage of participants with soft birth canal laceration after delivery. |
| Incidence of Episiotomy | At delivery | Percentage of participants who undergo episiotomy during vaginal delivery. |
| Incidence of Operative Vaginal Delivery | At delivery | Percentage of participants who undergo forceps-assisted or vacuum-assisted vaginal delivery. |
| Neonatal Birth Weight | At birth | Birth weight of the newborn. |
| Apgar Score at 1 Minute | 1 minute after birth | Apgar score assessed 1 minute after birth. |
| Apgar Score at 5 Minutes | 5 minutes after birth | Apgar score assessed 5 minutes after birth. |
| Apgar Score at 10 Minutes | 10 minutes after birth | Apgar score assessed 10 minutes after birth. |
| Umbilical Artery Blood pH | At birth | Umbilical artery blood pH value when available. |
| Admission to the Neonatal Intensive Care Unit | From birth to 48 hours after birth | Percentage of newborns admitted to the neonatal intensive care unit. |
| Incidence of Neonatal Infection | From birth to 48 hours after birth | Percentage of newborns with neonatal infection. |
| Incidence of Meconium Aspiration | From birth to 48 hours after birth | Percentage of newborns with meconium aspiration. |
| Incidence of Neonatal Hypoxia | From birth to 48 hours after birth | Percentage of newborns with neonatal hypoxia. |
| Incidence of Perinatal Death | From birth to 7 days after birth | Percentage of perinatal deaths. |
| Maternal Satisfaction | 2-3 days postpartum before discharge | Maternal satisfaction with the delivery process will be assessed using a patient satisfaction survey before discharge. |
| Incidence of Postpartum Pelvic Floor Dysfunction | 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. |
| Incidence of Postpartum Depression | 42 days postpartum | Postpartum depression will be assessed using the Edinburgh Postnatal Depression Scale according to routine clinical practice. |
Countries
China
Contacts
CONTACTYifeng Zhong, Associate Professor
PRINCIPAL_INVESTIGATORYifeng Zhong, Associate Professor
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed