Vaginal DeliveryNCT07707804
Bionic Balloon-assisted Delivery Technology on the Labor Process
A study testing Bionic Balloon-assisted Delivery and Routine Labor Management in people with Vaginal Delivery, run by Peking Union Medical College Hospital at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Vaginal Delivery
- What is being tested?
- Bionic Balloon-assisted Delivery and Routine Labor Management
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 4 sitesChina
- Study dates
- 15 Jul 2026to 15 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
Beijing Obstetrics and Gynecology Hospital
Beijing
Yifeng Zhong, +86 18612708860, ZYFL1026@163.com
Beijing Tongren Hospital
Beijing
Yifeng Zhong, +86 18612708860, ZYFL1026@163.com
Peking Union Medical College Hospital
Beijing
Yifeng Zhong, +86 18612708860, ZYFL1026@163.com
Cangzhou Central Hospital
Cangzhou, Hebei
Yifeng Zhong, +86 18612708860, ZYFL1026@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Vaginal Delivery
- Being tested
- Bionic Balloon-assisted Delivery, Routine Labor Management
- Keywords
- Bionic balloon-assisted delivery, Labor duration, Maternal outcomes, Neonatal outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bionic Balloon-assisted DeliveryDevice
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.
Routine Labor ManagementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Balloon Group | Experimental | 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. Receives: Device: Bionic Balloon-assisted Delivery |
| Control Group | Active comparator | 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. Receives: Procedure: Routine Labor Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From onset of labor to delivery of the placenta.
Secondary outcomes (21)
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.
Measured: During labor and delivery
Incidence of Intrapartum Fever
Percentage of participants with body temperature greater than or equal to 38 degrees Celsius after the onset of labor.
Measured: From onset of labor to delivery
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.
Measured: Within 24 hours after delivery
Incidence of Postpartum Infection
Percentage of participants with postpartum infection requiring antibiotic treatment after delivery.
Measured: From 24 hours to 48 hours after delivery
Incidence of Urinary Retention
Percentage of participants with intrapartum or postpartum urinary retention.
Measured: From onset of labor to 48 hours after delivery
Incidence of Soft Birth Canal Laceration
Percentage of participants with soft birth canal laceration after delivery.
Measured: At delivery
Incidence of Episiotomy
Percentage of participants who undergo episiotomy during vaginal delivery.
Measured: At delivery
Incidence of Operative Vaginal Delivery
Percentage of participants who undergo forceps-assisted or vacuum-assisted vaginal delivery.
Measured: At delivery
Neonatal Birth Weight
Birth weight of the newborn.
Measured: At birth
Apgar Score at 1 Minute
Apgar score assessed 1 minute after birth.
Measured: 1 minute after birth
Apgar Score at 5 Minutes
Apgar score assessed 5 minutes after birth.
Measured: 5 minutes after birth
Apgar Score at 10 Minutes
Apgar score assessed 10 minutes after birth.
Measured: 10 minutes after birth
Umbilical Artery Blood pH
Umbilical artery blood pH value when available.
Measured: At birth
Admission to the Neonatal Intensive Care Unit
Percentage of newborns admitted to the neonatal intensive care unit.
Measured: From birth to 48 hours after birth
Incidence of Neonatal Infection
Percentage of newborns with neonatal infection.
Measured: From birth to 48 hours after birth
Incidence of Meconium Aspiration
Percentage of newborns with meconium aspiration.
Measured: From birth to 48 hours after birth
Incidence of Neonatal Hypoxia
Percentage of newborns with neonatal hypoxia.
Measured: From birth to 48 hours after birth
Incidence of Perinatal Death
Percentage of perinatal deaths.
Measured: From birth to 7 days after birth
Maternal Satisfaction
Maternal satisfaction with the delivery process will be assessed using a patient satisfaction survey before discharge.
Measured: 2-3 days postpartum before discharge
Incidence of Postpartum Pelvic Floor Dysfunction
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.
Measured: 42 days postpartum
Incidence of Postpartum Depression
Postpartum depression will be assessed using the Edinburgh Postnatal Depression Scale according to routine clinical practice.
Measured: 42 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start15 Jul 2026 (estimated)
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaginal DeliveryStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yifeng Zhong, Peking Union Medical College Hospital
- Investigators
- Yifeng Zhong, Associate Professor, Principal investigator, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07707804
- Sponsor's protocol ID
- I-26PJ1429
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Zhang M, Xy Z. Clinical application of airbag bionic midwifery technology in vaginal delivery of pregnancy with scarred uterus. Afr J Reprod Health. 2024 Nov 30;28(11):78-84. doi: 10.29063/ajrh2024/v28i11.8.
PubMed 39756009
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on The Impact of Bionic Balloon-assisted Delivery Technology on the Labor Process and Maternal and Neonatal Outcomes
- ClinicalTrials.gov ID
- NCT07707804
- Acronym / sponsor ID
- I-26PJ1429
- Conditions
- Vaginal Delivery
- Keywords
- Bionic balloon-assisted delivery, Labor duration, Maternal outcomes, Neonatal outcomes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Balloon Group | Experimental | Device: Bionic Balloon-assisted DeliveryParticipants 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. |
| Control Group | Active comparator | Procedure: Routine Labor ManagementParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bionic Balloon-assisted DeliveryBionic 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. | Device | Balloon Group |
| Routine Labor ManagementRoutine 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. | Procedure or surgery | Control Group |
Primary outcome
Duration of Labor
Time frame: 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.
21 secondary outcomes
Intrapartum Cesarean Conversion Rate
Time frame: During labor and delivery
Incidence of Intrapartum Fever
Time frame: From onset of labor to delivery
Incidence of Postpartum Hemorrhage
Time frame: Within 24 hours after delivery
Incidence of Postpartum Infection
Time frame: From 24 hours to 48 hours after delivery
Incidence of Urinary Retention
Time frame: From onset of labor to 48 hours after delivery
Incidence of Soft Birth Canal Laceration
Time frame: At delivery
Incidence of Episiotomy
Time frame: At delivery
Incidence of Operative Vaginal Delivery
Time frame: At delivery
Neonatal Birth Weight
Time frame: At birth
Apgar Score at 1 Minute
Time frame: 1 minute after birth
Apgar Score at 5 Minutes
Time frame: 5 minutes after birth
Apgar Score at 10 Minutes
Time frame: 10 minutes after birth
Umbilical Artery Blood pH
Time frame: At birth
Admission to the Neonatal Intensive Care Unit
Time frame: From birth to 48 hours after birth
Incidence of Neonatal Infection
Time frame: From birth to 48 hours after birth
Incidence of Meconium Aspiration
Time frame: From birth to 48 hours after birth
Incidence of Neonatal Hypoxia
Time frame: From birth to 48 hours after birth
Incidence of Perinatal Death
Time frame: From birth to 7 days after birth
Maternal Satisfaction
Time frame: 2-3 days postpartum before discharge
Incidence of Postpartum Pelvic Floor Dysfunction
Time frame: 42 days postpartum
Incidence of Postpartum Depression
Time frame: 42 days postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Background: PubMed 39756009Zhang M, Xy Z. Clinical application of airbag bionic midwifery technology in vaginal delivery of pregnancy with scarred uterus. Afr J Reprod Health. 2024 Nov 30;28(11):78-84. doi: 10.29063/ajrh2024/v28i11.8.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yifeng Zhong, Associate Professor principal investigator
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bionic Balloon-assisted Delivery and Routine Labor Management in people with Vaginal Delivery, run by Peking Union Medical College Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yifeng Zhong, Associate Professor (+86 18612708860, ZYFL1026@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Labor (time frame: From onset of labor to delivery of the placenta.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07707804, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.