PregnancyPhase 2/3NCT07576881
Impact of Standardization on Outcomes Following Cervical Ripening
A Phase 2/3 study testing Cervical Ripening with a double balloon catheter only and Cervical ripening with a double balloon catheter plus misoprostol in people with Pregnancy, run by Indiana University at 1 site in United States.
Trial summary
The primary purpose of this study is to determine if vaginal delivery rate is impacted by the use of standardized methods of cervical ripening. Additional outcomes will be evaluated including maternal and fetal outcomes of labor. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Cervical Ripening with a double balloon catheter only and Cervical ripening with a double balloon catheter plus misoprostol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,158 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2026to Apr 2028
- Phase
- Phase 2/3
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are scheduled for medically indicated or elective induction of labor with gestational age ≥37 weeks at Eskenazi hospital
- Willing and able to provide informed consent
- Age ≥18 years old
- Able to read, speak and understand English, Spanish or Haitian Creole
Who cannot join
- Premature rupture of membranes
- Known chorioamnionitis
- Fetal malpresentation
- Placenta previa
- Category 3 fetal heart rate tracing -- only at the time of screening and enrollment. If a Category III tracing develops later in labor, this will prompt standard obstetric management, not removal from the study.
- Prior uterine scar (cesarean delivery or other contraindication to use of prostaglandins)
Show all 11Show fewer
- Major fetal anomalies known at the time of enrollment that are expected to meaningfully impact labor management
- Multiple gestation
- Allergy to misoprostol or other contraindication to induction of labor or use of misoprostol or cook cervical ripening balloon
- Patient does not require cervical ripening (SBS ≥ 6 or dilation ≥ 4cm)
- Significant acute or chronic medical, neurologic, or illness in the patient that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Sidney & Lois Eskenazi Hospital
Indianapolis, Indiana, 46202
Sarah M Carpenter, MD, 317-880-2229, semorgan@iu.edu
About this study
The primary purpose of this study is to determine if vaginal delivery rate is impacted by the use of standardized methods of cervical ripening. Additional outcomes will be evaluated including maternal and fetal outcomes of labor.
Read the detailed description
The goal of this study is to evaluate the impact of standardization of cervical ripening on labor outcomes as well as to evaluate whether different methods of cervical ripening influence labor outcomes The primary outcome will be SVD rate. Secondary outcomes will include time from admission to delivery, total duration of hospitalization (admission to discharge), operative vaginal delivery rate, incidence of delivery within 24 hours of admission, maximal dose of oxytocin (in mU/min), incidence of tachysystole requiring intervention, incidence of intervention for fetal bradycardia or "non-reassuring fetal status", maternal morbidity (endometritis, 3rd or 4th degree lacerations, hemorrhage >1000mL, blood transfusion, wound separation or infection or readmission), neonatal length of stay>3 days, NICU admission.
- Conditions
- Pregnancy
- Being tested
- Cervical Ripening with a double balloon catheter only, Cervical ripening with a double balloon catheter plus misoprostol, Usual-care control group
- Keywords
- cervical ripening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Ripening with a double balloon catheter onlyDevice
Labor induction will include cervical ripening with the use of a double balloon catheter without medication at the same time. After the balloon comes out (is taken out or falls out), the rest of the labor course will be managed by your provider
Cervical ripening with a double balloon catheter plus misoprostolCombination product
The labor induction will include cervical ripening with the use of a double balloon catheter and the medication misoprostol at the same time. After the balloon comes out (is taken out or falls out), the rest of your labor course will be managed by the provider.
Usual-care control groupCombination product
Cervical ripening will occur using the method chosen by the provider as part of standard clinical care. This may include the use of a double balloon catheter, misoprostol, both, or other methods commonly used for induction of labor.
| Study group | Role | What they receive |
|---|---|---|
| Cervical Ripening with a double balloon catheter only | Experimental | Not described Receives: Device: Cervical Ripening with a double balloon catheter only |
| Cervical ripening with a double balloon catheter plus misoprostol | Experimental | Not described Receives: Combination Product: Cervical ripening with a double balloon catheter plus misoprostol |
| Usual-care control group | Active comparator | Cervical ripening will occur using the method chosen by your provider as part of standard clinical care. This may include the use of a double balloon catheter, misoprostol, both, or other methods commonly used for induction of labor. Receives: Combination Product: Usual-care control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
SVD rate
The primary outcome measure for this study is Spontaneous Vaginal Delivery (SVD) rate which is measured as the proportion of patients who deliver vaginally.
Measured: From enrollment until delivery, up to four days
Secondary outcomes (11)
SVD rate for study arm 1 versus study arm 2 (% difference)
Comparing (Spontaneous Vaginal Delivery) SVD rates between Cervical Ripening with a double balloon catheter only arm and Cervical ripening with a double balloon catheter plus misoprostol arm.
Measured: From enrollment until delivery, up to four days
Incidence of delivery within 24 hours of admission
Measured: Enrollment until delivery, up to four days
Incidence of tachysystole requiring intervention
Measured: Enrollment until study completion, up to 94 days
Incidence of intervention for fetal bradycardia or "non reassuring fetal status"
Measured: Enrollment until study completion, up to 94 days
Rate of Maternal endometritis
Measured: Enrollment until study completion, up to 94 days
Composite maternal morbidity
measured by % endometritis, 3rd or 4th degree lacerations, QBL >1000mL, intrapartum or postpartum blood transfusion, wound separation or infection, hospital readmission within 30 days after delivery
Measured: From delivery until 30 days after delivery
neonatal length of stay >3 days
Measured: From delivery until 3 days post delivery
Rate of NICU admission
Measured: From delivery until study completion, up to 94 days
Quantitative Blood Loss
blood loss measured in mL
Measured: From delivery until discharge, up to 4 days
Time from admission to delivery
Measured: From admission until delivery, up to four days
Total duration of hospitalization
Total duration of hospitalization measured from admission to discharge
Measured: From admission to discharge, up to 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start29 Jul 2026
- Primary completionDec 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University Health
- Responsible party
- Principal investigator, Sarah Morgan Carpenter, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07576881
- Sponsor's protocol ID
- 27548
- Status last verified
- May 2026
- First submitted
- 26 Feb 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Standardization on Outcomes Following Cervical Ripening
- ClinicalTrials.gov ID
- NCT07576881
- Acronym / sponsor ID
- 27548
- Conditions
- Pregnancy
- Keywords
- cervical ripening
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,158 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Indiana University Health
- Study start
- 29 Jul 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 8 May 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.
The primary purpose of this study is to determine if vaginal delivery rate is impacted by the use of standardized methods of cervical ripening. Additional outcomes will be evaluated including maternal and fetal outcomes of labor.
Detailed description
The goal of this study is to evaluate the impact of standardization of cervical ripening on labor outcomes as well as to evaluate whether different methods of cervical ripening influence labor outcomes The primary outcome will be SVD rate. Secondary outcomes will include time from admission to delivery, total duration of hospitalization (admission to discharge), operative vaginal delivery rate, incidence of delivery within 24 hours of admission, maximal dose of oxytocin (in mU/min), incidence of tachysystole requiring intervention, incidence of intervention for fetal bradycardia or "non-reassuring fetal status", maternal morbidity (endometritis, 3rd or 4th degree lacerations, hemorrhage >1000mL, blood transfusion, wound separation or infection or readmission), neonatal length of stay>3 days, NICU admission.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cervical Ripening with a double balloon catheter only | Experimental | Device: Cervical Ripening with a double balloon catheter only |
| Cervical ripening with a double balloon catheter plus misoprostol | Experimental | Combination Product: Cervical ripening with a double balloon catheter plus misoprostol |
| Usual-care control group | Active comparator | Combination Product: Usual-care control groupCervical ripening will occur using the method chosen by your provider as part of standard clinical care. This may include the use of a double balloon catheter, misoprostol, both, or other methods commonly used for induction of labor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are scheduled for medically indicated or elective induction of labor with gestational age ≥37 weeks at Eskenazi hospital
- Willing and able to provide informed consent
- Age ≥18 years old
- Able to read, speak and understand English, Spanish or Haitian Creole
Key exclusion criteria (11 listed)
- Premature rupture of membranes
- Known chorioamnionitis
- Fetal malpresentation
- Placenta previa
- Category 3 fetal heart rate tracing -- only at the time of screening and enrollment. If a Category III tracing develops later in labor, this will prompt standard obstetric management, not removal from the study.
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 |
|---|---|---|
| Cervical Ripening with a double balloon catheter onlyLabor induction will include cervical ripening with the use of a double balloon catheter without medication at the same time. After the balloon comes out (is taken out or falls out), the rest of the labor course will be managed by your provider | Device | Cervical Ripening with a double balloon catheter only |
| Cervical ripening with a double balloon catheter plus misoprostolThe labor induction will include cervical ripening with the use of a double balloon catheter and the medication misoprostol at the same time. After the balloon comes out (is taken out or falls out), the rest of your labor course will be managed by the provider. | Combination product | Cervical ripening with a double balloon catheter plus misoprostol |
| Usual-care control groupCervical ripening will occur using the method chosen by the provider as part of standard clinical care. This may include the use of a double balloon catheter, misoprostol, both, or other methods commonly used for induction of labor. | Combination product | Usual-care control group |
Primary outcome
SVD rate
Time frame: From enrollment until delivery, up to four days
The primary outcome measure for this study is Spontaneous Vaginal Delivery (SVD) rate which is measured as the proportion of patients who deliver vaginally.
11 secondary outcomes
SVD rate for study arm 1 versus study arm 2 (% difference)
Time frame: From enrollment until delivery, up to four days
Incidence of delivery within 24 hours of admission
Time frame: Enrollment until delivery, up to four days
Incidence of tachysystole requiring intervention
Time frame: Enrollment until study completion, up to 94 days
Incidence of intervention for fetal bradycardia or "non reassuring fetal status"
Time frame: Enrollment until study completion, up to 94 days
Rate of Maternal endometritis
Time frame: Enrollment until study completion, up to 94 days
Composite maternal morbidity
Time frame: From delivery until 30 days after delivery
neonatal length of stay >3 days
Time frame: From delivery until 3 days post delivery
Rate of NICU admission
Time frame: From delivery until study completion, up to 94 days
Quantitative Blood Loss
Time frame: From delivery until discharge, up to 4 days
Time from admission to delivery
Time frame: From admission until delivery, up to four days
Total duration of hospitalization
Time frame: From admission to discharge, up to 8 days
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 27 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cervical Ripening with a double balloon catheter only and Cervical ripening with a double balloon catheter plus misoprostol in people with Pregnancy, run by Indiana University at 1 site in United States.
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 11 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Shelley Dowden, BS (317-880-3954, sburn@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SVD rate (time frame: From enrollment until delivery, up to four days). 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 27 Oct 2026.