- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04041687
Outpatient Cervical Ripening
Outpatient Cervical Ripening With Misoprostol in Low-Risk Inductions After 39 Weeks Gestation: a Cost, Safety, and Satisfaction Analysis
Study Overview
Status
Conditions
Detailed Description
This study will attempt to assess whether outpatient cervical ripening with misoprostol, a synthetic PGE1 analog (Cytotec(R), Pfizer), is an effective and safe option for low-risk pregnant women at or after 39 weeks gestation with an unfavorable cervix. This study comes in the wake of the ARRIVE trial, which may reasonably increase the number of low-risk term inductions.
The process of labor induction, including cervical ripening, can take several hours or even days. This prolonged course contributes not only to long hospital stays and subsequently increased financial burden to both patients and healthcare systems, but also to patient and provider dissatisfaction with length of induction. Additionally, with the expected increase in elective inductions of primigravid women with unfavorable cervices as a result of the ARRIVE study, hospitals face the possibility of being at capacity on labor and delivery with inadequate staffing to ensure patient safety.
Traditionally, the process of cervical ripening begins after inpatient hospital admission. Several small studies have evaluated outpatient ripening with various agents including foley balloon catheters, PGE1 analogs such as misoprostol, and other prostaglandins. The American College of Obstetricians and Gynecologists has commented on the limited data available on outpatient cervical ripening safety and efficacy, noting that outpatient cervical ripening is "appropriate for carefully selected patients" in Practice Bulletin 107. Data have been reassuring as far as safety and efficacy based on several studies, but are limited due to small sample size, For example, a randomized, double-blind placebo-controlled study in 2009 found that outpatient oral misoprostol for late term pregnancies had a significantly shorter time from study entry to spontaneous labor and delivery. This study showed no difference in fetal or maternal morbidity, but was not powered to safety as there were only 44 subjects per group (10). Some institutions including OB/GYN groups at Beth Israel Deaconess Hospital, South Shore Hospital in MA, and Alaska Native medical center have incorporated outpatient ripening into their everyday practices, but little data on outcomes have been published from these sites.
The investigators aim to determine if outpatient cervical ripening is a safe, non-inferior option to the traditional inpatient cervical ripening. The investigators will evaluate whether outpatient ripening impacts patient satisfaction, patient/hospital costs, and adverse outcomes in our health system setting. Cervical ripening is standard care at other OB/GYN practices across the county and the investigators intend to apply this care pathway for patients. The investigator's goal is to ensure the safety of participants by carefully selecting low risk patients and providing necessary fetal monitoring before and after administration. The results of this study can be used to determine if outpatient cervical ripening can be incorporated in daily practices of OB/GYN providers at GHS.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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South Carolina
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Greenville, South Carolina, United States, 29605
- Prisma Health
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Low risk, pregnant women seeking elective induction of labor after 39 weeks gestation
- Women without a medical indication for induction of labor.
- Multigravida or primigravida women who are scheduled for late term (postdates) induction will be included.
Exclusion Criteria:
- Previous cesarean section,
- Any contraindication to labor or vaginal delivery,
- A ny patients where misoprostol should be used with caution (IUGR, oligohydramnios)
- Bishop score > 6
- ruptured amnioticmembranes
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess outpatient cervical ripening protocol feasibility
Time Frame: one year
|
length of induction misoprostol, a synthetic PGE1 analog (Cytotec®, Pfizer, New York), is an effective and safe option for low-risk pregnant women with an unfavorable cervix at or after 39 weeks gestation.
|
one year
|
Assess outpatient cervical ripening protocol feasibility
Time Frame: one year
|
unplanned/unanticipated admissions
|
one year
|
Assess outpatient cervical ripening protocol feasibility
Time Frame: one year
|
Rate of change in Bishop score
|
one year
|
Assess outpatient cervical ripening protocol feasibility
Time Frame: one year
|
number of misoprostol doses required
|
one year
|
Assess outpatient cervical ripening protocol feasibility
Time Frame: one year
|
number of cervical checks performed
|
one year
|
Assess outpatient cervical ripening protocol feasibility
Time Frame: one year
|
rates of chorioamnionitis or endometritis
|
one year
|
Assess outpatient cervical ripening protocol feasibility
Time Frame: one year
|
fetal or neonatal complications
|
one year
|
Assess outpatient cervical ripening protocol feasibility
Time Frame: one year
|
other maternal complications of induction or delivery
|
one year
|
Assess outpatient cervical ripening protocol feasibility
Time Frame: one year
|
apgar scores
|
one year
|
Assess outpatient cervical ripening protocol feasibility
Time Frame: one year
|
route of delivery - vaginal delivery with or without assistance, cesarean section and indication
|
one year
|
Assess outpatient cervical ripening protocol feasibility
Time Frame: one year
|
satisfaction - patient and provider, via survey (labor agentry questionnaire) for outpatient group
|
one year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lauren Demosthenes, MD, Prisma Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- pro00084666
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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