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Study on Misoprostol for Inducing Labor in Pregnant Women: Comparing Outpatient and Inpatient Settings

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on the process of inducing labor, which is when medical methods are used to help start childbirth. The study is examining the use of a medication called misoprostol, which is taken as a tablet. The purpose of the study is to determine if inducing labor at home is as safe and effective as doing it in a hospital setting.

Participants in the study will be randomly assigned to either have their labor induced at home or in the hospital. The study will monitor the safety and effectiveness of both methods by looking at outcomes such as the health of the mother and baby, the method of delivery, and the experiences of the women and their partners. The study will also gather information on the cost-effectiveness of each method and the experiences of healthcare staff involved in the process.

The trial aims to provide valuable insights into whether home-based labor induction can be a safe and effective option for expectant mothers, potentially offering more flexibility and comfort during the childbirth process. The study will continue until the end of 2028, with results being collected and analyzed to help inform future practices in labor induction.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on medical history and clinical examination. This includes being between 18-45 years old, having a stable pregnancy, and being able to reach the hospital within 60 minutes if needed.

  2. Step 2

    Initial assessment

    An initial assessment is conducted, which includes a physical examination and various tests such as an ultrasound and a CTG scan to monitor the baby's heart rate and the mother's contractions.

  3. Step 3

    Medication administration

    The medication misoprostol is administered orally in the form of a tablet called Angusta 25 microgram. The dosage and frequency are determined by the healthcare provider based on individual needs.

  4. Step 4

    Monitoring period

    After taking the medication, a monitoring period of 45 minutes is required to ensure the safety and effectiveness of the induction process. This includes continuous observation and additional CTG scans if necessary.

  5. Step 5

    Outpatient induction

    The study aims to evaluate the safety and effectiveness of inducing labor in an outpatient setting. Participants may be allowed to return home after the initial monitoring, with instructions to return to the hospital as needed.

  6. Step 6

    Follow-up and delivery

    Participants are followed up regularly to monitor the progress of labor. The goal is to achieve a vaginal delivery, and the healthcare team will provide guidance and support throughout the process.

  7. Step 7

    Post-delivery evaluation

    After delivery, both the mother and baby are evaluated for any health concerns. The study collects data on delivery outcomes and maternal and neonatal health.

  8. Step 8

    Final assessment

    A final assessment is conducted to gather information on the overall experience, including any complications or additional care required. This helps in understanding the effectiveness and safety of outpatient labor induction.

Who can join the trial?

10 criteria

  • Women aged 18 to 45 years old.
  • Must be able to reach the hospital within a reasonable time, ideally within 60 minutes.
  • Must be able to communicate with the hospital.
  • Must have a straightforward pregnancy with one baby.
  • Pregnancy should be between 37 weeks and 41 weeks and 6 days, based on early ultrasound measurements.
  • The baby should be in a head-down position, known as cephalic presentation.
  • Before starting the induction, a medical check-up will confirm the baby is in a head-down position.
  • The Bishop score, which assesses readiness for labor, should be less than 6.
  • A CTG scan, which monitors the baby's heartbeat, should be normal according to specific guidelines.
  • If using a catheter method for induction, the CTG scan should remain normal during the first 45 minutes.

Who cannot join the trial?

10 criteria

  • Participants must not have any medical conditions that could make the study unsafe for them.
  • Participants should not have any complications with their pregnancy that could affect the study.
  • Participants must not have any allergies or reactions to the medications used in the study.
  • Participants should not be currently participating in another clinical trial.
  • Participants must not have any history of serious health issues that could interfere with the study.
  • Participants should not be unable to follow the study instructions or attend the required visits.
  • Participants must not have any conditions that require immediate medical attention.
  • Participants should not be under the age of 18.
  • Participants must not be male, as the study is only for females.
  • Participants should not be part of a vulnerable population that requires special protection.
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Investigated drugs

  • Misoprostol

    is a medication used to help start labor in pregnant women. It works by softening and opening the cervix, which can help the uterus contract and begin the process of childbirth. This medication is often used in situations where it is necessary to induce labor for medical reasons.

  • Dinoprostone

    is another medication used to induce labor. It is similar to misoprostol in that it helps to prepare the cervix for labor by making it softer and more open. This can help the uterus to start contracting and initiate the labor process.

  • Oxytocin

    is a hormone that is often used in labor induction. It helps to stimulate contractions of the uterus, which can help to start or speed up labor. Oxytocin is usually given through an IV and is carefully monitored to ensure the safety of both the mother and the baby.

What is already known about the treatment

Misoprostol – Misoprostol is administered orally or vaginally and is used to induce labor in pregnant women. It is currently recognized in medical literature as a medication for labor induction, with ongoing studies to evaluate its safety and effectiveness in outpatient settings. The main therapeutic indication for Misoprostol is the induction of labor. At the molecular level, it works by binding to prostaglandin receptors in the uterus, causing uterine contractions. It is classified pharmacologically as a prostaglandin E1 analog.

Investigated diseases

Induction of Labor – Induction of labor is a medical procedure used to stimulate uterine contractions before natural labor begins, with the goal of achieving a vaginal delivery. This process is typically considered when continuing the pregnancy poses risks to the mother or baby, or when the pregnancy has extended beyond the due date. The progression of labor induction involves the use of medications or mechanical methods to encourage the cervix to open and contractions to start. The effectiveness of induction can vary, with some women experiencing a quick onset of labor, while others may require additional interventions. The procedure is monitored closely to ensure the safety and well-being of both the mother and the baby.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507164-39-00Estimated enrolment8 891 patientsSponsorUniversity Of Gothenburg

sourced from the EU Clinical Trials Register and site verification

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