Oral Misoprostol for Outpatient Induction of Labor

Oral Misoprostol for Outpatient Induction of Labor; a Pilot Randomized-controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Labor Induction
• Intervention / Treatment: Other: Inpatient setting; Other: Outpatient setting

Detailed Description

The implementation of induction of labor in outpatient settings is increasing despite insufficient evidence regarding safety and effectiveness. The use of a balloon catheter in an outpatient setting is not associated with adverse outcomes in a low-risk population. There is also evidence that outpatient vs inpatient induction of labor with balloon catheter is equally effective. Examination of vaginal dinoprostone (prostaglandin E2) is found to be efficacious in outpatient settings. However, strong evidence concludes that the oral route of administration of prostaglandin is preferable when inducing labor. The World Health Organization recommend 25ug misoprostol (prostaglandin E1) orally every 2 hour until contractions start for induction of labor.

The women randomized to an inpatient setting will receive the hospital standard follow-up; oral misoprostol 25ug every two hours and a cardiotocography for fetal monitoring every 4-6 hour until start of contractions for two days.

The women randomized to an outpatient setting will receive one oral misoprostol 25ug at the maternity unit. After two hours, provided a normal cardiotocography and no contractions, they can go home. They will continue to take 25ug misoprostol every two hours until start of contractions or increasing pain. Maximum time spent at home will be 48 hours.

A dedicated midwife on call will always be available for questions. The women will receive oral and written information to return to the maternity unit if the water breaks, if they experience increasing pain or bleeding, if they feel insecure or anxious, if there are reduced or no fetal movements, and/or when the contraction starts. When the woman returns, she will stay admitted until delivery.

All women will be given standard of care and fetal surveillance when admitted to the hospital, when the contractions start or if the contractions are still absent after 48 hours. We will also ask eligible women who refrain to participate about their reasons for non-participation.

PRIMARY RESEARCH QUESTION We aim to explore that induction of labor using oral misoprostol appears feasible in an outpatient setting and may positively influence the length of the hospital stay and maternal satisfaction.

PRIMARY RESEARCH PLAN This is a pilot study to explore the feasibility of a possible multicenter randomized controlled trail.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Kristiansand, Norway, 4604
    • Sorlandet Hospital Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Induction of labour with oral misoprostol, inpatient setting; These women receive all treatment in the maternity unit.	Other: Inpatient setting; These women stay at the hospital.
Experimental: Induction of labour with oral misoprostol, outpatient setting; 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; These women can leave the hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reported labor experience among the women participating	The women will fill out a survey before and after birth (including childbirth expectations, experience and satisfaction)	From included in the study until postpartum discharge (1-2 weeks)
Maternal length of hospital stay	Length of hospital stay form start of induction to postpartum discharge	From included in the study until postpartum discharge (1-2 weeks)
Use of analgesia	Use of epidural and fentanyl analgesia during labor	From start of the partogram until birth (hours)

Collaborators and Investigators

• Sponsor: Sorlandet Hospital HF
• Investigators: Principal Investigator: Janne Rossen, MD, PhD, Sorlandet Hospital Trust, Kristiansand, Norway

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2020
• Primary Completion (Actual): March 15, 2021
• Study Completion (Actual): March 25, 2021

Study Registration Dates

• First Submitted: October 12, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 15, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: misoprostol; induction of labor; outpatient setting
• Other Study ID Numbers: 2020/104044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No