Outpatient Induction of Labor With Oral Misoprostol

NCT05144048 | Completed DMC

• 1 other identifier: 261787/2021
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

induction; outpatient; misoprostol; childbirth experience

Outcome Measures

Primary Outcomes (1)

• Maternal childbirth experience and maternal experience with induction of labor

  The women will answer electronic questionaires at inclusion and postpartum

  up to 12 days after delivery

Secondary Outcomes (2)

• Labor outcomes

  From 1 hour to average of 48 hours

• Cost per delivery

  through study completion, an average of 1 year

Study Arms (2)

Induction of labour with oral misoprostol, inpatient setting

ACTIVE COMPARATOR

These women receive all treatment in the maternity unit.

Other: Inpatient setting

Induction of labour with oral misoprostol, outpatient setting

EXPERIMENTAL

These women are observed 2 hours after they receive one dose of oral misoprostol before they leave the maternity unit.

Other: Outpatient setting

Interventions

Inpatient setting OTHER

These women stay at the maternity unit

Induction of labour with oral misoprostol, inpatient setting

Outpatient setting OTHER

These women leave the maternity unit

Induction of labour with oral misoprostol, outpatient setting

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sorlandet Hospital HF: lead
• Haukeland University Hospital: collaborator
• St. Olavs Hospital: collaborator
• Nordlandssykehuset HF: collaborator
• Ostfold Hospital Trust: collaborator

Study Sites (5)

Haukeland University Hospital

Bergen, Norway

Location

Nordlandssykehuset HF

Bodø, Norway

Location

Østfold Hospital Trust

Fredrikstad, Norway

Location

Sorlandet Hospital Trust

Kristiansand, 4604, Norway

Location

St. Olavs Hospital

Trondheim, Norway

Location

Related Publications (7)

• WHO recommendations: Induction of labour at or beyond term. Geneva: World Health Organization; 2018. Available from http://www.ncbi.nlm.nih.gov/books/NBK535795/

  PMID: 30629393 BACKGROUND

• Alfirevic Z, Gyte GM, Nogueira Pileggi V, Plachcinski R, Osoti AO, Finucane EM. Home versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007372. doi: 10.1002/14651858.CD007372.pub4.

  PMID: 32852803 BACKGROUND

• Alfirevic Z, Aflaifel N, Weeks A. Oral misoprostol for induction of labour. Cochrane Database Syst Rev. 2014 Jun 13;2014(6):CD001338. doi: 10.1002/14651858.CD001338.pub3.

  PMID: 24924489 BACKGROUND

• McDonagh M, Skelly AC, Tilden E, Brodt ED, Dana T, Hart E, Kantner SN, Fu R, Hermesch AC. Outpatient Cervical Ripening: A Systematic Review and Meta-analysis. Obstet Gynecol. 2021 Jun 1;137(6):1091-1101. doi: 10.1097/AOG.0000000000004382.

  PMID: 33752219 BACKGROUND

• Helmig RB, Hvidman LE. An audit of oral administration of Angusta(R) (misoprostol) 25 microg for induction of labor in 976 consecutive women with a singleton pregnancy in a university hospital in Denmark. Acta Obstet Gynecol Scand. 2020 Oct;99(10):1396-1402. doi: 10.1111/aogs.13876. Epub 2020 May 19.

  PMID: 32311758 BACKGROUND

• Ten Eikelder ML, Oude Rengerink K, Jozwiak M, de Leeuw JW, de Graaf IM, van Pampus MG, Holswilder M, Oudijk MA, van Baaren GJ, Pernet PJ, Bax C, van Unnik GA, Martens G, Porath M, van Vliet H, Rijnders RJ, Feitsma AH, Roumen FJ, van Loon AJ, Versendaal H, Weinans MJ, Woiski M, van Beek E, Hermsen B, Mol BW, Bloemenkamp KW. Induction of labour at term with oral misoprostol versus a Foley catheter (PROBAAT-II): a multicentre randomised controlled non-inferiority trial. Lancet. 2016 Apr 16;387(10028):1619-28. doi: 10.1016/S0140-6736(16)00084-2. Epub 2016 Feb 3.

  PMID: 26850983 BACKGROUND

• Austad FE, Kessler J, Magnussen EB, Pripp AH, Rossen J. Outpatient Versus Inpatient Induction of Labour With Oral Misoprostol: A Multicentre Randomised-Controlled Trial. BJOG. 2025 Oct;132(11):1562-1573. doi: 10.1111/1471-0528.18296. Epub 2025 Jul 24.

  PMID: 40704452 DERIVED

Study Officials

• Janne Rossen, MD, PhD

  Sorlandet HF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The women will be randomized using a secure survey tool to an inpatient or outpatient setting.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: All eligible women will be recruited form a midwife and/or doctor. After the inclusion the women will be randomized to either inpatient or outpatient setting.

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: December 3, 2021
• Study Start: January 1, 2022
• Primary Completion: March 29, 2023
• Study Completion: April 29, 2023
• Last Updated: October 24, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (5)