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

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What is this study about?

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.

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 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 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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Region Vaestmanland	Vasteras	Sweden

Other Sites

Site Name	City	Country
Danderyds Sjukhus AB	Danderyd	Sweden
Region Oestergoetland	Linkoping	Sweden
Region Oerebro Laen	Orebro	Sweden
Region Skane Helsingborg Hospital	Helsingborg	Sweden
Region Stockholm – SLSO	Stockholm	Sweden
Region Dalarna	Falun	Sweden
Region Norrbotten	Lulea	Sweden
Region Halland	Varberg	Sweden
Soedra Aelvsborg Hospital Vaestra Goetalandsregionen	Boras	Sweden
Skaraborg Hospital-Vaestra Goetalandsregionen	Skovde	Sweden
Region Vaesternorrland	Sundsvall	Sweden
Region Blekinge	Karlskrona	Sweden
NU Hospital Group-Vaestra Goetalandsregionen	Trollhattan	Sweden
Region Soermland	Nykoping	Sweden
Vrinnevisjukhuset I Norrkoeping Region Oestergoetland	Norrkoping	Sweden
Region Jaemtland Haerjedalen	Ostersund	Sweden
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Karolinska University Hospital	Solna	Sweden
Region Skane Kristianstad Central Hospital	Kristianstad	Sweden
Malarsjukhuset Eskilstuna	Eskilstuna	Sweden
Region Joenkoepings Laen	Jönköping	Sweden
Region Kronoberg	Vaxjo	Sweden
Region Vaesterbotten	Umea	Sweden
Soedersjukhuset AB	Stockholm	Sweden
Region Gaevleborg	Gavle	Sweden
Vpzxirwkcbt Sdlhhgr Royhbn Khqyxe Lacz	Vastervik	Sweden
Sfjztfqtfkc Szgqcpc Av	Sodertalje	Sweden
Uuvwpuz Uvthenwtrm Hyvcrmss	Uppsala	Sweden
Szngwhtbbre Upvubvdhyv Hfvgbytejwqucrs Ggrawsigzeyngylty	Gothenburg	Sweden
Rxazjq Vwhfmaqhj	Karlstad	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Recruiting	01.12.2021

Trial locations

Investigated drugs:

Misoprostol

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.

Investigated diseases:

Labour induction

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 ID:

2023-507164-39-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?