Skip to main content
OpenTrials
Completed

NCT Number: NCT05144048

Outpatient Induction of Labor With Oral Misoprostol

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital, Bergen, Norway

Loading trial locations.

About this study

After induction of labor is decided the women will be recruited according to inclusion and exclusion criteria's.

The inpatient induction group will receive the following treatment:

Oral misoprostol 25ug every two hours and a cardiotocography for fetal monitoring every 4-6 hours until start of contractions, the next 48 hours while admitted to the maternity ward. The participating women will be transferred to the labor ward by start of contractions or need for closer fetal surveillance and/or analgesia.

The outpatient induction group will receive the following treatment:

These participating women receive the first oral misoprostol 25ug at the maternity unit. After two hours if the cardiotocograph is normal and there are no signs of contractions, these women go home. At home, the women will continue to take 25ug misoprostol every two hours until 22 pm or until the contractions begin. Maximum time spent at home is 48 hours and maximum number of tablets is 12 during this period (6 tablets each day). The women will also receive oral and written information regarding when to return to the maternity ward. Information sheets for the midwives and included women will be adapted from those used in the pilot study.

If the contractions are still absent after 48 hours or a maximum of 12 tablets (6 per day), all women (both inpatient and outpatient) are admitted to the maternity ward for further induction of labor. All women will receive equal standard of care including fetal surveillance after admittance to the hospital. Further follow up is in accordance with standard procedure of the maternity ward. Questions about fidelity to the proposed protocol across sites will be asked in the patient questionnaire.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ≥ 37 gestational weeks, vertex presentation, single pregnancy
  • Age ≥ 18 years
  • Understand and read Norwegian
  • Distance to hospital less than 1 hour
  • Normal ultrasound including:
  • fetal movements
  • amniotic fluid (deepest single vertical pocket) > 2 cm
  • estimated fetal weight ≥ -15% (≥ 10 percentile)
  • Normal antenatal cardiotocography
  • Women with stable hypertension and uncomplicated preeclampsia without indication for inpatient treatment can be included after individual assessment.
  • Access to partner or contact person at home for transportation to hospital

Exclusion criteria

  • Premature rupture of membranes
  • Uterine scar
  • BMI ≥ 40
  • Abnormal fetal Doppler (if examined); umbilical artery pulsatility index ≥ 95 percentile and/or cerebroplacental ratio <1
  • Fetal anomaly or chromosomic / genetic disorder
  • Grand multipara (P≥4)
  • Cognitive barriers
  • Pregnancy complications such as preeclampsia requiring in-hospital treatment, insulin dependent diabetes or other conditions associated with risk of fetal hypoxia during labor
  • Signs of infection or serious health problems
  • Favorable cervix and / or previous obstetric history providing contraindications for induction with misoprostol
  • Combined risk factors, individually evaluated by the attending obstetrician

Treatment and study plan

Inpatient setting

Other

These women stay at the maternity unit

Outpatient setting

Other

These women leave the maternity unit

Primary outcomes

  1. Maternal childbirth experience and maternal experience with induction of labor

    Time frame: up to 12 days after delivery

    The women will answer electronic questionaires at inclusion and postpartum

Secondary outcomes

  1. Labor outcomes

    Time frame: From 1 hour to average of 48 hours

    Hours from start induction and start active labor

  2. Cost per delivery

    Time frame: through study completion, an average of 1 year

    We will calculate the differences of costs and effects of one or more alternatives, and present the differences in the form of a ratio (ICER), i.e. the cost per unit of health outcome or effect. We will calculate cost-effectiveness (δ costs / δ effects) to evaluate whether outpatient induction shows to be dominant strategy regarding patient satisfaction.

Sponsors and collaborators

Lead sponsor

Sorlandet Hospital HF

Other Gov

Collaborators

  • Haukeland University Hospital
  • Nordlandssykehuset HF
  • Ostfold Hospital Trust
  • St. Olavs Hospital

Registry information

Official study title

Outpatient Induction of Labor With Oral Misoprostol: A Multicenter Randomized-controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 3, 2021
Registry last updated
Oct 24, 2023

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.

Published trials that share one or more normalized conditions with this study.