Primiparous WomenPhase 4NCT07690007
Combined Misoprostol and Cervical Balloon vs Misoprostol Alone for Induction on the First Day in Primiparas
A Phase 4 study testing Misoprostol and Misoprostol plus Cervical Balloon in people with Primiparous Women, run by Peking University First Hospital.
Trial summary
Misoprostol (a prostaglandin E1 analog) is commonly used for cervical ripening and labor induction via vaginal administration. The cervical balloon is another commonly used method that provides mechanical cervical dilation. Both methods are low-cost and widely available. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Primiparous Women
- What is being tested?
- Misoprostol and Misoprostol plus Cervical Balloon
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2026to 31 Dec 2026
- Phase
- Phase 4
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 20-45 years at delivery
- Singleton pregnancy
- Primiparous
- Cephalic presentation
- Cervical Bishop score ≤ 5
- No history of stillbirth
Who cannot join
- Multiple pregnancy
- Contraindications to vaginal delivery
- Mental disorders (depression or anxiety)
- Preterm labor (< 37 weeks)
- Intrauterine fetal death
- Previous uterine surgery
- Premature rupture of membranes
- Abnormal fetal heart rate tracing
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Jianhua Niu, M.D. contact
About this study
Official title: Efficacy of Intravaginal Misoprostol Combined With Cervical Balloon Versus Misoprostol Alone for Induction of Labor on the First Day in Primiparous Women: A Randomized Controlled Trial
Misoprostol (a prostaglandin E1 analog) is commonly used for cervical ripening and labor induction via vaginal administration. The cervical balloon is another commonly used method that provides mechanical cervical dilation. Both methods are low-cost and widely available. Some meta-analyses have suggested that combined use may shorten the duration of labor, reduce the frequency of tachysystole, and lower NICU admission rates without increasing the risk of cesarean section. However, existing studies are heterogeneous and lack data from Asian populations.
This study is being done to see whether combining two common methods of labor induction-misoprostol (a medicine placed in the vagina) and a cervical balloon (placed in the cervix) on the first day of induction-can shorten the time from the start of induction to delivery in first-time mothers during pregnancy .
Participants will be randomly assigned to one of two groups: one group will receive misoprostol alone (standard care) on the first day of induction, and the other group will receive misoprostol plus a cervical balloon on the first day of induction. The main outcome measured is the time from the start of induction to delivery. The study will also look at safety outcomes, including the rate of cesarean section, maternal complications, and newborn outcomes.
Read the detailed description
This is a single-center, randomized, open-label, superiority randomized controlled trial. Participants will be randomly assigned in a 1:1 ratio to either the intervention group (misoprostol plus cervical balloon on the first day of induction) or the control group (misoprostol alone on the first day of induction).
IPRIMARY OUTCOME:
Time from initiation of labor induction to delivery (hours).
SECONDARY OUTCOMES:
Time from induction to amniotomy (min), time from induction to spontaneous membrane rupture (h), time from induction to onset of labor (min), duration of balloon use (min), duration of oxytocin use (min), duration of latent phase (h), duration of first and second stages of labor (min), mode of delivery, degree of perineal laceration, indications for forceps/episiotomy/cesarean section, fetal distress, intrauterine infection, neonatal outcomes (birth weight, Apgar score, umbilical artery pH/BE, NICU admission), and maternal hemoglobin difference before and after delivery. Safety outcomes include placental abruption, septic shock, and severe postpartum hemorrhage.
SAMPLE SIZE:
Based on historical data from 90 primiparous women at Peking University First Hospital (June 2025), the mean induction-to-delivery interval was 39.07 ± 19.92 hours. Assuming an 8-hour reduction in the intervention group, with a two-sided alpha of 0.05, power of 80%, and a 10% dropout rate, each group requires 110 participants (total 220).
STATISTICAL ANALYSIS:
Continuous variables will be compared using t-test or Mann-Whitney U test as appropriate. Categorical variables will be compared using chi-square or Fisher's exact test. Multivariable linear regression and logistic regression will be used for adjusted analyses. Subgroup analyses will be performed by type of hyperglycemia, age, BMI, and baseline Bishop score.
ETHICS AND REGISTRATION:
This study has been approved by the Biomedical Research Ethics Committee of Peking University First Hospital (Approval No. 2025R0393-0002, dated September 25, 2025). The study is registered on ClinicalTrials.gov.
STUDY PERIOD:
June 2026 to December 2026.
- Conditions
- Primiparous Women
- Being tested
- Misoprostol, Misoprostol plus Cervical Balloon
- Keywords
- labor induction, misoprostol, foley balloon catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
25 μg misoprostol tablet placed in the posterior vaginal fornix for cervical ripening and labor induction on the first day. May be repeated up to 3-4 times based on uterine contraction response (monitored every 2-4 hours).
Misoprostol plus Cervical BalloonDevice
A Cervical balloon with 80 mL sterile water inflation placed intracervically for mechanical cervical dilation. The balloon is left in place for up to 12-24 hours or until spontaneous expulsion.
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol Plus Cervical Balloon | Experimental | Participants receive 25 μg misoprostol placed in the posterior vaginal fornix, combined with a Cervical balloon catheter (80 mL inflation) placed intracervically for 12-24 hours on the first day of induction. Misoprostol may be repeated up to 3-4 times based on uterine contraction response. Receives: Device: Misoprostol plus Cervical Balloon |
| Misoprostol Alone | Active comparator | Participants receive 25 μg misoprostol placed in the posterior vaginal fornix alone on the first day of induction. Misoprostol may be repeated up to 3-4 times based on uterine contraction response. Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from initiation of labor induction to delivery
Time in hours from the start of labor induction (placement of first dose of misoprostol or Foley balloon) to vaginal delivery or cesarean section.
Measured: Time from initiation of induction measures on the first day of induction to delivery (control group: time of first misoprostol placement; intervention group: time of cervical balloon and misoprostol placement).
Secondary outcomes (20)
Time from Induction to Amniotomy
Duration from the start of induction (placement of misoprostol or balloon+misoprostol) to the performance of amniotomy, measured in minutes.
Measured: From start of induction to amniotomy
Time from Induction to Spontaneous Membrane Rupture
Duration from the start of induction to spontaneous rupture of fetal membranes, measured in hours.
Measured: From start of induction to spontaneous rupture
Time from Induction to Onset of Labor
Duration from the start of induction to the establishment of regular painful uterine contractions with cervical opening, measured in minutes.
Measured: From start of induction to onset of labor
Duration of Balloon Use
Total time the cervical balloon remains in place (from insertion to removal), measured in minutes.
Measured: From balloon insertion to removal, assessed during the induction period (up to 24 hours).
Duration of Oxytocin Use
Total duration of oxytocin administration during labor, measured in minutes.
Measured: From start to stop of oxytocin infusion, assessed during labor
Duration of Latent Phase of Labor
Time from onset of labor to cervical dilation of 5 cm, measured in hours.
Measured: From onset of labor to active phase, assessed during labor
Duration of First and Second Stages of Labor
Time from full cervical dilation (first stage) to delivery of the newborn (second stage), measured in minutes
Measured: From full dilation to delivery, assessed during the second stage
Mode of Delivery
Categorization of delivery as spontaneous vaginal, vacuum/forceps-assisted, or cesarean section.
Measured: At the time of delivery.
Degree of Perineal Laceration
Severity of perineal tears classified as first-, second-, third-, or fourth-degree.
Measured: Immediately after vaginal delivery.
Indications for Forceps/Episiotomy/Cesarean Section
Clinical reasons for performing forceps delivery, episiotomy, or cesarean section (e.g., fetal distress, arrest of labor).
Measured: At the time of the operative intervention (during labor/delivery).
Fetal Distress
Presence of fetal distress diagnosed by abnormal fetal heart rate patterns or acidemia during labor.
Measured: During labor, assessed up to delivery.
Intrauterine Infection
Clinical or histologic diagnosis of chorioamnionitis or endometritis during or after delivery.
Measured: During labor and up to 48 hours postpartum.
Neonatal Birth Weight
Weight of the newborn measured immediately after delivery, in grams.
Measured: At delivery (immediately after birth).
Apgar Score
Apgar score assessed at 1 and 5 minutes after birth, range 0-10.
Measured: At 1 and 5 minutes after birth.
Umbilical Artery pH and Base Excess
pH and base excess (BE) values measured in umbilical artery blood at delivery.
Measured: Immediately after delivery (from cord blood).
NICU Admission
Whether the newborn is admitted to the NICU after delivery.
Measured: After birth.
Maternal Hemoglobin Difference
Difference between pre-delivery (baseline) and post-delivery hemoglobin levels, measured in g/dL.
Measured: Baseline (before induction) and within 24-48 hours after delivery.
Placental Abruption
Premature separation of the placenta from the uterine wall, diagnosed clinically or by ultrasound.
Measured: During labor and delivery
Septic Shock
Severe infection leading to circulatory failure, requiring vasopressors.
Measured: Before or after birth
Severe Postpartum Hemorrhage
Estimated blood loss ≥1000 mL or requiring transfusion or surgical intervention.
Measured: Within 24 hours after delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start30 Jun 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primiparous WomenStudies of the same condition, open and under way.
- More trials run by Peking University First 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ye Feng, M.D., Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690007
- Sponsor's protocol ID
- 2025R0393-0002
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intravaginal Misoprostol Combined With Cervical Balloon Versus Misoprostol Alone for Induction of Labor on the First Day in Primiparous Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07690007
- Acronym / sponsor ID
- 2025R0393-0002
- Conditions
- Primiparous Women
- Keywords
- labor induction, misoprostol, foley balloon catheter
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 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.
Misoprostol (a prostaglandin E1 analog) is commonly used for cervical ripening and labor induction via vaginal administration. The cervical balloon is another commonly used method that provides mechanical cervical dilation. Both methods are low-cost and widely available. Some meta-analyses have suggested that combined use may shorten the duration of labor, reduce the frequency of tachysystole, and lower NICU admission rates without increasing the risk of cesarean section. However, existing studies are heterogeneous and lack data from Asian populations.
This study is being done to see whether combining two common methods of labor induction-misoprostol (a medicine placed in the vagina) and a cervical balloon (placed in the cervix) on the first day of induction-can shorten the time from the start of induction to delivery in first-time mothers during pregnancy .
Participants will be randomly assigned to one of two groups: one group will receive misoprostol alone (standard care) on the first day of induction, and the other group will receive misoprostol plus a cervical balloon on the first day of induction. The main outcome measured is the time from the start of induction to delivery. The study will also look at safety outcomes, including the rate of cesarean section, maternal complications, and newborn outcomes.
Detailed description
This is a single-center, randomized, open-label, superiority randomized controlled trial. Participants will be randomly assigned in a 1:1 ratio to either the intervention group (misoprostol plus cervical balloon on the first day of induction) or the control group (misoprostol alone on the first day of induction).
IPRIMARY OUTCOME:
Time from initiation of labor induction to delivery (hours).
SECONDARY OUTCOMES:
Time from induction to amniotomy (min), time from induction to spontaneous membrane rupture (h), time from induction to onset of labor (min), duration of balloon use (min), duration of oxytocin use (min), duration of latent phase (h), duration of first and second stages of labor (min), mode of delivery, degree of perineal laceration, indications for forceps/episiotomy/cesarean section, fetal distress, intrauterine infection, neonatal outcomes (birth weight, Apgar score, umbilical artery pH/BE, NICU admission), and maternal hemoglobin difference before and after delivery. Safety outcomes include placental abruption, septic shock, and severe postpartum hemorrhage.
SAMPLE SIZE:
Based on historical data from 90 primiparous women at Peking University First Hospital (June 2025), the mean induction-to-delivery interval was 39.07 ± 19.92 hours. Assuming an 8-hour reduction in the intervention group, with a two-sided alpha of 0.05, power of 80%, and a 10% dropout rate, each group requires 110 participants (total 220).
STATISTICAL ANALYSIS:
Continuous variables will be compared using t-test or Mann-Whitney U test as appropriate. Categorical variables will be compared using chi-square or Fisher's exact test. Multivariable linear regression and logistic regression will be used for adjusted analyses. Subgroup analyses will be performed by type of hyperglycemia, age, BMI, and baseline Bishop score.
ETHICS AND REGISTRATION:
This study has been approved by the Biomedical Research Ethics Committee of Peking University First Hospital (Approval No. 2025R0393-0002, dated September 25, 2025). The study is registered on ClinicalTrials.gov.
STUDY PERIOD:
June 2026 to December 2026.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol Plus Cervical Balloon | Experimental | Device: Misoprostol plus Cervical BalloonParticipants receive 25 μg misoprostol placed in the posterior vaginal fornix, combined with a Cervical balloon catheter (80 mL inflation) placed intracervically for 12-24 hours on the first day of induction. Misoprostol may be repeated up to 3-4 times based on uterine contraction response. |
| Misoprostol Alone | Active comparator | Drug: MisoprostolParticipants receive 25 μg misoprostol placed in the posterior vaginal fornix alone on the first day of induction. Misoprostol may be repeated up to 3-4 times based on uterine contraction response. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 20-45 years at delivery
- Singleton pregnancy
- Primiparous
- Cephalic presentation
- Cervical Bishop score ≤ 5
Key exclusion criteria (8 listed)
- Multiple pregnancy
- Contraindications to vaginal delivery
- Mental disorders (depression or anxiety)
- Preterm labor (< 37 weeks)
- Intrauterine fetal death
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 |
|---|---|---|
| Misoprostol25 μg misoprostol tablet placed in the posterior vaginal fornix for cervical ripening and labor induction on the first day. May be repeated up to 3-4 times based on uterine contraction response (monitored every 2-4 hours). | Drug | Misoprostol Alone |
| Misoprostol plus Cervical BalloonA Cervical balloon with 80 mL sterile water inflation placed intracervically for mechanical cervical dilation. The balloon is left in place for up to 12-24 hours or until spontaneous expulsion. | Device | Misoprostol Plus Cervical Balloon |
Primary outcome
Time from initiation of labor induction to delivery
Time frame: Time from initiation of induction measures on the first day of induction to delivery (control group: time of first misoprostol placement; intervention group: time of cervical balloon and misoprostol placement).
Time in hours from the start of labor induction (placement of first dose of misoprostol or Foley balloon) to vaginal delivery or cesarean section.
20 secondary outcomes
Time from Induction to Amniotomy
Time frame: From start of induction to amniotomy
Time from Induction to Spontaneous Membrane Rupture
Time frame: From start of induction to spontaneous rupture
Time from Induction to Onset of Labor
Time frame: From start of induction to onset of labor
Duration of Balloon Use
Time frame: From balloon insertion to removal, assessed during the induction period (up to 24 hours).
Duration of Oxytocin Use
Time frame: From start to stop of oxytocin infusion, assessed during labor
Duration of Latent Phase of Labor
Time frame: From onset of labor to active phase, assessed during labor
Duration of First and Second Stages of Labor
Time frame: From full dilation to delivery, assessed during the second stage
Mode of Delivery
Time frame: At the time of delivery.
Degree of Perineal Laceration
Time frame: Immediately after vaginal delivery.
Indications for Forceps/Episiotomy/Cesarean Section
Time frame: At the time of the operative intervention (during labor/delivery).
Fetal Distress
Time frame: During labor, assessed up to delivery.
Intrauterine Infection
Time frame: During labor and up to 48 hours postpartum.
Neonatal Birth Weight
Time frame: At delivery (immediately after birth).
Apgar Score
Time frame: At 1 and 5 minutes after birth.
Umbilical Artery pH and Base Excess
Time frame: Immediately after delivery (from cord blood).
NICU Admission
Time frame: After birth.
Maternal Hemoglobin Difference
Time frame: Baseline (before induction) and within 24-48 hours after delivery.
Placental Abruption
Time frame: During labor and delivery
Septic Shock
Time frame: Before or after birth
Severe Postpartum Hemorrhage
Time frame: Within 24 hours after delivery.
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 8 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Primiparous Women
Recruiting
The Effect Of Partner-Assısted Rebozo Technıque On Labor Paın And Satısfactıon In Prımary Pregnant Women
Labor Pains
Not yet recruiting
Coloring Activity Applied During Labor in Primiparous Pregnant Women and Its Effect on Birth Anxiety and Fear of Childbirth
Fear of Childbirth, Mandala Coloring
Recruiting
Virtual Reality-Enabled Digital Storytelling
Primiparous Pregnant Women
Not yet recruiting
The Effect of Model-based Education on Breastfeeding Self-efficacy and Success
Breastfeeding
Not yet recruiting
The Effects of Innatal Yoga Practices on Pain, Comfort, and Satisfaction in Primiparous Women
Primiparous Pregnant Women, Yoga
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.
Jianhua Niu, M.D. contact
Ye Feng, M.D. principal investigator
Peking University First Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Misoprostol and Misoprostol plus Cervical Balloon in people with Primiparous Women, run by Peking University First Hospital.
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 6 inclusion and 8 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 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ye Feng, M.D. (8618001203634, fengye_bjmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from initiation of labor induction to delivery (time frame: Time from initiation of induction measures on the first day of induction to delivery (control group: time of first misoprostol placement; intervention group: time of cervical balloon and misoprostol placement).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2026.