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Completed

NCT Number: NCT04041687

Outpatient Cervical Ripening

The process of labor induction can mean several hours or even days spent as an inpatient prior to delivery. These prolonged hospital admissions contribute to increased financial burden on both patients and hospital systems, dissatisfaction with induction length, and staffing concerns. Several obstetric practices in the U.S. have already incorporated outpatient cervical ripening (the beginning of the induction process) into their regular practices. The investigators aim to determine if outpatient cervical ripening is a safe, non-inferior, and preferred option to the traditional inpatient induction process.

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Key information

Conditions

Pregnancy

Sex eligibility

Female

Study type

Observational

Primary location

Prisma Health

Greenville, South Carolina, 29605, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. Assess outpatient cervical ripening protocol feasibility

    Time frame: one year

    unplanned/unanticipated admissions

  3. Assess outpatient cervical ripening protocol feasibility

    Time frame: one year

    Rate of change in Bishop score

  4. Assess outpatient cervical ripening protocol feasibility

    Time frame: one year

    number of misoprostol doses required

  5. Assess outpatient cervical ripening protocol feasibility

    Time frame: one year

    number of cervical checks performed

  6. Assess outpatient cervical ripening protocol feasibility

    Time frame: one year

    rates of chorioamnionitis or endometritis

  7. Assess outpatient cervical ripening protocol feasibility

    Time frame: one year

    fetal or neonatal complications

  8. Assess outpatient cervical ripening protocol feasibility

    Time frame: one year

    other maternal complications of induction or delivery

  9. Assess outpatient cervical ripening protocol feasibility

    Time frame: one year

    apgar scores

  10. Assess outpatient cervical ripening protocol feasibility

    Time frame: one year

    route of delivery - vaginal delivery with or without assistance, cesarean section and indication

  11. Assess outpatient cervical ripening protocol feasibility

    Time frame: one year

    satisfaction - patient and provider, via survey (labor agentry questionnaire) for outpatient group

Sponsors and collaborators

Lead sponsor

Prisma Health-Upstate

Other

Registry information

Official study title

Outpatient Cervical Ripening with Misoprostol in Low-Risk Inductions After 39 Weeks Gestation: a Cost, Safety, and Satisfaction Analysis

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 1, 2019
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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