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Outpatient Induction of Labor With Oral Misoprostol

NCT05144048 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2023-10-24

No results posted yet for this study

Summary

Induction of labor is an increasingly used intervention in obstetrics due to expanding indications, which more often includes relatively healthy women with uncomplicated pregnancies. While induction of labor traditionally is offered in an inpatient setting, a shift towards an outpatient setting is increasing despite insufficient evidence regarding safety and effectiveness. Oral misoprostol is easy for the pregnant women to administer and the risk of uterine hyperstimulation with fetal heart rate changes is found to be low. Strong evidence concludes that oral misoprostol is preferable as an induction agent and is recommended by the World Health Organization (WHO).

The investigators will perform a multicenter randomized-controlled trial comparing labor induction in an outpatient versus inpatient setting, aiming to increase knowledge on outpatient induction of labor with oral misoprostol. The study is based on experiences and findings from a recently performed pilot trial and targets a large group of relatively healthy pregnant women where induction of labor is decided.

The investigators hypothesize that women induced in an outpatient setting will be more satisfied than women induced in an inpatient setting.

Conditions

  • Induction of Labor

Interventions

OTHER

Inpatient setting

These women stay at the maternity unit

OTHER

Outpatient setting

These women leave the maternity unit

Sponsors & Collaborators

  • Haukeland University Hospital

    collaborator OTHER

  • St. Olavs Hospital

    collaborator OTHER

  • Nordlandssykehuset HF

    collaborator OTHER

  • Ostfold Hospital Trust

    collaborator OTHER

  • Sorlandet Hospital HF

    lead OTHER_GOV

Principal Investigators

  • Janne Rossen, MD, PhD · Sorlandet HF

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2023-03-29
Completion
2023-04-29

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05144048 on ClinicalTrials.gov