Impact of Standardization on Outcomes Following Cervical Ripening
Indiana University · with Indiana University Health · NCT07576881
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · Women only
- Healthy volunteers
- Accepted
- Study type
- Interventional · Phase 2, Phase 3
- Target enrollment
- 1158
- US sites recruiting
- 1
- Study start
- July 29, 2026
- Record last updated
- October 27, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Cervical Ripening with a double balloon catheter only; Cervical ripening with a double balloon catheter plus misoprostol; Usual-care control group
Conditions: Pregnancy
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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)
- 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
Recruiting US locations
Sidney & Lois Eskenazi Hospital
Indianapolis, IN 46202
Site contact: Sarah M Carpenter, MD · 317-880-2229 · semorgan@iu.edu
Study contacts (from the official record)
- Shelley Dowden, BS · 317-880-3954 · sburn@iu.edu
Similar studies in Indiana
All pregnancy studies in Indiana →- RecruitingPhase 3
Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome
Aerogen Pharma Limited
- Location
- South Bend, IN + 17 other US sites
- Eligibility basics
- Any age listed
- RecruitingHealthy volunteersPhase 2
Low Dose Aspirin for the Prevention of Postpartum Related Breast Cancer
Mayo Clinic
- Location
- Indianapolis, IN + 3 other US sites
- Eligibility basics
- Ages 18–45 · Women only
- RecruitingHealthy volunteers
Personalized Perioperative Analgesia Platform (PPAP) for Cesarean Section
Senthil Sadhasivam
- Location
- Indianapolis, IN + 2 other US sites
- Eligibility basics
- Ages 18+ · Women only
- RecruitingHealthy volunteers
The Society for Obstetric Anesthesia and Perinatology Research Network General Anesthesia Registry
Yale University
- Location
- Indianapolis, IN + 32 other US sites
- Eligibility basics
- Ages 15–55 · Women only