Oral Misoprostol for Outpatient Induction of Labor

NCT04596397 | Completed

• 1 other identifier: 2020/104044
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

An increasing proportion of pregnant women have their labors induced due to changing guidelines. In correlation with this increase, the population of the induced women has changed toward more women with a low-risk pregnancy. Traditionally, induction of labor has taken place in an inpatient setting where the women have spent extra days in hospital before delivery. Oral prostaglandins, such as misoprostol, is one of the most commonly used induction agent and is easy for the pregnant women to administrate. The pharmacological effect is ripening the cervix and compared to the mechanical cervical ripening, with a balloon catheter, the demands on busy maternity services seems reduced. Before contractions start, the risk of adverse effects on mother or fetus is considered low, but the evidence on use of misoprostol in an outpatient setting is sparse.

Conditions

Labor Induction

Keywords

induction of labor; outpatient setting; misoprostol

Outcome Measures

Primary Outcomes (1)

• The feasibility of a randomised controlled trial of outpatient labor induction

  The number of eligible women who is willing to enrol in participating

  6 months

Secondary Outcomes (3)

• Reported labor experience among the women participating

  From included in the study until postpartum discharge (1-2 weeks)

• Maternal length of hospital stay

  From included in the study until postpartum discharge (1-2 weeks)

• Use of analgesia

  From start of the partogram until birth (hours)

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 will be observed 2 hours after they receive one dose of oral misoprostol before the can leave the maternity unit.

Other: Outpatient setting

Interventions

Inpatient setting OTHER

These women stay at the hospital.

Induction of labour with oral misoprostol, inpatient setting

Outpatient setting OTHER

These women can leave the hospital.

Induction of labour with oral misoprostol, outpatient setting

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Understand and read Norwegian
• No cognitive barriers. The woman must be able to give informed consent
• ≥ 37 gestational week, vertex presentation, single pregnancy
• Normal ultrasound including fetal movements, amniotic fluid, estimated fetal weight +/- 15% (≤ 10 percentile and ≥ 90) and normal doppler peak systolic index in the umbilical cord artery and the cerebri media artery
• Normal cardiotocography
• Body Mass Index 18-35
• No signs of infection or health problems
• Distance to hospital 45-60 minutes

You may not qualify if:

• Premature rupture of membranes
• Previous cesarean section or operation on uterus
• Fetal anomaly or chromosome/genetic disorder
• Pregnancy complications such as preeclampsia and diabetes (insulin dependent) or other conditions were changes in fetal heart rate during labor is suspected
• Not eligible for misoprostol as induction agent due a favorable cervix (Bishop score) and/or previous obstetric history

Sponsors & Collaborators

• Sorlandet Hospital HF: lead

Study Sites (1)

Sorlandet Hospital Trust

Kristiansand, 4604, Norway

Location

Related Publications (5)

• Vogel JP, Osoti AO, Kelly AJ, Livio S, Norman JE, Alfirevic Z. Pharmacological and mechanical interventions for labour induction in outpatient settings. Cochrane Database Syst Rev. 2017 Sep 13;9(9):CD007701. doi: 10.1002/14651858.CD007701.pub3.

  PMID: 28901007 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

• WHO Recommendations for Induction of Labour. Geneva: World Health Organization; 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK131963/

  PMID: 23586118 BACKGROUND

• Diederen M, Gommers J, Wilkinson C, Turnbull D, Mol B. Safety of the balloon catheter for cervical ripening in outpatient care: complications during the period from insertion to expulsion of a balloon catheter in the process of labour induction: a systematic review. BJOG. 2018 Aug;125(9):1086-1095. doi: 10.1111/1471-0528.15047. Epub 2018 Jan 10.

  PMID: 29211328 BACKGROUND

• Wilkinson C, Bryce R, Adelson P, Turnbull D. A randomised controlled trial of outpatient compared with inpatient cervical ripening with prostaglandin E(2) (OPRA study). BJOG. 2015 Jan;122(1):94-104. doi: 10.1111/1471-0528.12846. Epub 2014 May 14.

  PMID: 24824157 BACKGROUND

Study Officials

• Janne Rossen, MD, PhD

  Sorlandet Hospital Trust, Kristiansand, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The women included will be randomized from number 1 -20 where number 1-10 are inpatient and number 11-20 are outpatient.
• 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 they will be randomized to either inpatient or outpatient setting.

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 22, 2020
• Study Start: November 16, 2020
• Primary Completion: March 15, 2021
• Study Completion: March 25, 2021
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)