NCT04746248: LINO

Outpatient Labor Induction Using Oral Misoprostol in Norway

Completed NA Last updated 24 March 2023

What this trial tests

NA trial testing Outpatient labor induction in Induced; Birth in 200 participants. Completed in 31 December 2022.

Timeline

25 March 2021

Primary endpoint
31 December 2022

31 December 2022

Quick facts

Lead sponsor	Oslo Metropolitan University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	200
Start date	25 March 2021
Primary completion	31 December 2022
Estimated completion	31 December 2022
Sites	2 locations across Norway

Drugs / interventions tested

• Outpatient labor induction
• Inpatient labor induction

Conditions studied

• Induced; Birth — all drugs for Induced; Birth →
• Labor, Induced — all drugs for Labor, Induced →

Sponsor

Oslo Metropolitan University

Who can join

Adults 18 to 42, female only, with Induced; Birth or Labor, Induced. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

This is a non-randomized prospective pilot- and feasibility study, collecting data from electronical records. In addition, the study participants are invited to write a diary during the labor induction process and a questionnaire six weeks postpartum. Eligible patients include low-risk nulliparous women induced with low-dose oral misoprostol.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Outpatient labor induction-Exploring future potential by assessing eligibility in a historical cohort.
   Marsdal KE, Sørbye IK, Bernitz S, Sve RET, et al · · 2024 · cited 4× · PMID 38504457 · DOI 10.1111/aogs.14799
2. Clinical outcomes and feasibility of implementing outpatient labor induction with misoprostol: A prospective cohort study.
   Marsdal KE, Sørbye IK, Bernitz S, Adan N, et al · · 2025 · cited 2× · PMID 39878306 · DOI 10.1111/aogs.15029