Comparing outpatient and inpatient methods for cervical ripening in pregnancy
Cost of Inpatient Care for Women Undergoing Outpatient vs. Inpatient Transcervical Balloon Cervical Ripening for Induction of Labor at Term
This study is testing whether using a balloon for cervical ripening at home is just as effective and cheaper than doing it in the hospital for pregnant women getting ready for labor.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 412 (estimated) |
| Ages | 18 Years to 39 Years |
| Sex | Female |
| Sponsor | Lehigh Valley Hospital Academic / other |
| Locations | 1 site (Allentown, Pennsylvania) |
| Trial ID | NCT05506631 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness and cost implications of outpatient cervical ripening using a transcervical balloon compared to traditional inpatient cervical ripening. It will measure the length of hospital stay from admission for labor induction to delivery for both groups. Additionally, the study will analyze the costs associated with each method to determine potential savings and efficiencies in care. The findings could help inform best practices for managing labor induction in pregnant women at term.
Who should consider this trial
Good fit: Ideal candidates are pregnant women at 39 weeks or more gestation, scheduled for induction of labor, with a singleton pregnancy and specific cervical conditions.
Not a fit: Patients requiring continuous fetal monitoring or those with complications that necessitate inpatient observation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more efficient and cost-effective care for women undergoing labor induction.
How similar studies have performed: While similar approaches have been explored, this specific cost comparison between outpatient and inpatient cervical ripening is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Pregnant women at ≥39 weeks gestation by reliable dating criteria as determined by the American College of Obstetricians and Gynecologists * Scheduled induction of labor with indication and timing supported by Lehigh Valley Health Network -Labor and Delivery Units (Cedar Crest \& Muhlenberg) * Singleton gestation * Cephalic presentation * Amniotic fluid index normal * Formal prenatal ultrasound during the pregnancy documenting the absence of placenta previa * Bishop score \<6 and cervical dilation \<3cm at the time of decision to induce labor * The woman is able to give appropriate consent and has undergone an informed consent process. * Maternal age ≥ 18 years old at the time of consent * English speaking Exclusion Criteria * Undergoing outpatient antenatal testing for any medical or obstetric condition * Need for inpatient observation or continuous fetal monitoring during their cervical ripening * New diagnosis requiring immediate hospitalization for monitoring (such as new onset hypertensive disease of pregnancy) * Vaginal bleeding * Active labor * Premature rupture of membranes * Uterine tachysystole (\>5 contractions in 10 minutes) * Non-reassuring fetal heart tracing before Foley placement * Intrauterine fetal demise diagnosed after enrollment and before placement of balloon * Contraindication to vaginal delivery, relative or absolute (i.e. transfundal uterine surgery) * Abnormal placentation including a low lying placenta * Prior cesarean delivery * Known fetal major anomaly * Human immunodeficiency virus, Hepatitis C, or active herpes infection * Maternal cardiopulmonary disease requiring cardiac monitoring during labor * Pregestational diabetes or GDMA2 * Rh isoimmunization * Non-English speaking * BMI \> 40 * Distance from the hospital over 60 minutes by car, unreliable communication via telephone, or unreliable transportation
Where this trial is running
Allentown, Pennsylvania
- Lehigh Valley Health Network — Allentown, Pennsylvania, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.