Outpatient Labor Induction Using Oral Misoprostol in Norway

NCT04746248 | Completed

• 1 other identifier: 158844
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

The rate of labor induction has been steadily increasing over the last years, both worldwide and in Norway. Norwegian women are hospitalized when prostaglandins are used to induce labor. In Denmark, a neighboring country to Norway, women have been offered outpatient induction of labor using oral misoprostol for several years. The overall aim of this study is to investigate if outpatient induction of labor is beneficial in a Norwegian setting. This includes:

1. 1.To investigate the clinical outcomes and feasibility of inducing in an outpatient setting compared to an inpatient setting in Norway
2. 2.To explore low-risk nulliparous women's experiences of labor induction in inpatient and outpatient settings.

Conditions

Induced; Birth; Labor, Induced

Keywords

Labor induction; Induced birth; Outpatient; Oral misoprostol

Outcome Measures

Primary Outcomes (3)

• The proportion of eligible women selecting outpatient labor induction

  up to 18 months

• Fetal metabolic acidosis

  The proportion of fetal metabolic acidosis

  From delivery and within two hours postpartum

• Deliveries outside the hospital

  The proportion of deliveries outside the hospital in the outpatient versus inpatient induction group

  At time of delivery

Secondary Outcomes (22)

• Delivery mode

  At the time of delivery

• Indications for operative delivery

  At the time of delivery

• Uterine rupture

  During labor induction or birth

• Maternal admission to ICU or maternal death

  From start of induction through discharge, normally within 2-4 days after delivery

• Maternal hemorrhage (in ml)

  During birth and until two hours after delivery

Study Arms (3)

Baseline

NO INTERVENTION

The baseline arm includes participants from before the implementation of the outpatient regime. All participants are induced according to the standard inpatient protocol.

Women choosing to stay at the hospital

ACTIVE COMPARATOR

Include women who choose to stay at the hospital after implementing an outpatient alternative.

Other: Inpatient labor induction

Women choosing to go home

EXPERIMENTAL

Include women who choose the outpatient regime.

Other: Outpatient labor induction

Interventions

Outpatient labor induction OTHER

The participants stay at home during til labor induction process and are admitted to hospital at the onset of labor or if a complication occur. Outpatient consultations once a day.

Women choosing to go home

Inpatient labor induction OTHER

The participants are induced following standard inpatient care

Women choosing to stay at the hospital

Eligibility Criteria

• Age: 18 Years - 42 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy nulliparous women
• A single, healthy fetus in cephalic presentation at gestational age of 37 weeks or more
• Normal pregnancy
• The woman can read and communicate in Norwegian
• No cognitive barriers
• BMI 15,5-39,9
• Reside within one hour from the hospital
• Indication for labor induction is post term pregnancy, uncomplicated pre labor rupture of membranes, maternal wish or other indications determined as low-risk by the attending obstetrician

You may not qualify if:

• Known uterine abnormality or previous uterine surgery
• Major maternal medical illness requiring monitoring of mother or fetus in early labor
• Maternal infection
• Pregnancy complications such as preeclampsia, poorly controlled hypertension or medically treated diabetes mellitus
• Active vaginal bleeding characterized as more than bloody show
• Smoking
• Non-reassuring cardiotocography or reduced fetal movement
• Fetal growth EFW \< 10th percentile or \>90th percentile
• Poly- or oligohydramnios
• Known abnormalities in the placenta or umbilical cord

Sponsors & Collaborators

• Oslo Metropolitan University: lead
• Oslo University Hospital: collaborator
• Vestre Viken Hospital Trust: collaborator

Study Sites (2)

Vestre Viken Health Trust, Drammen Hospital

Drammen, Norway

Location

Oslo University Hospital

Oslo, Norway

Location

Related Publications (1)

• Marsdal KE, Sorbye IK, Bernitz S, Adan N, Grodal EB, Jacobsen AF, Lukasse M. Clinical outcomes and feasibility of implementing outpatient labor induction with misoprostol: A prospective cohort study. Acta Obstet Gynecol Scand. 2025 Apr;104(4):647-657. doi: 10.1111/aogs.15029. Epub 2025 Jan 29.

  PMID: 39878306 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 9, 2021
• Study Start: March 25, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)