Outpatient Cervical Ripening

NCT04041687 | Completed

• 1 other identifier: pro00084666
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy

Keywords

induction

Outcome Measures

Primary Outcomes (11)

• Assess outpatient cervical ripening protocol feasibility

  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

  unplanned/unanticipated admissions

  one year

• Assess outpatient cervical ripening protocol feasibility

  Rate of change in Bishop score

  one year

• Assess outpatient cervical ripening protocol feasibility

  number of misoprostol doses required

  one year

• Assess outpatient cervical ripening protocol feasibility

  number of cervical checks performed

  one year

• Assess outpatient cervical ripening protocol feasibility

  rates of chorioamnionitis or endometritis

  one year

• Assess outpatient cervical ripening protocol feasibility

  fetal or neonatal complications

  one year

• Assess outpatient cervical ripening protocol feasibility

  other maternal complications of induction or delivery

  one year

• Assess outpatient cervical ripening protocol feasibility

  apgar scores

  one year

• Assess outpatient cervical ripening protocol feasibility

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

  one year

• Assess outpatient cervical ripening protocol feasibility

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

  one year

Eligibility Criteria

• Gender Eligibility Details: pregnancy is condition of gender
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Low risk pregnant womenn

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Prisma Health-Upstate: lead

Study Sites (1)

Prisma Health

Greenville, South Carolina, 29605, United States

Location

Study Officials

• Lauren Demosthenes, MD

  Prisma Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: August 1, 2019
• Study Start: June 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)