Ongoing Clinical Trials for Labour Induction
Currently, there are 2 ongoing clinical trials exploring different approaches to labour induction. These studies are examining the use of medications such as misoprostol, oral sodium bicarbonate, and hyoscine butylbromide to improve the safety and effectiveness of starting labor in pregnant women. The trials are being conducted in Sweden and Norway.
Clinical trial locations
- Norway
- Sweden
Study on Misoprostol for Inducing Labor in Pregnant Women: Comparing Outpatient and Inpatient Settings
This trial is examining whether inducing labor at home is as safe and effective as doing it in a hospital setting. The study is taking place in Sweden and will continue until the end of 2028.
Main inclusion criteria: Women participating in this study must be between 18 and 45 years old and have a straightforward pregnancy with one baby in a head-down position. The pregnancy should be between 37 and 41 weeks and 6 days along. Participants must be able to reach the hospital within 60 minutes if needed and be able to communicate with the hospital. A medical check-up will confirm that the cervix is not yet ready for labor (Bishop score less than 6) and that the baby’s heartbeat monitoring (CTG scan) is normal.
Main exclusion criteria: Women cannot participate if they have medical conditions or pregnancy complications that could make the study unsafe. They also cannot take part if they have allergies to the study medications, are currently in another clinical trial, have serious health issues that could interfere with the study, or are unable to follow study instructions or attend required visits.
Focus of the trial: The study aims to determine if home-based labor induction can be a safe and effective option for expectant mothers, potentially offering more flexibility and comfort during the childbirth process. Researchers 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.
Investigational drugs: The trial is testing misoprostol, a medication taken as a tablet (Angusta 25 microgram) that helps soften and open the cervix and stimulates uterine contractions. The study may also involve dinoprostone, which works similarly to misoprostol in preparing the cervix for labor, and oxytocin, a hormone given through an IV that stimulates contractions to start or speed up labor.
Study on the Effectiveness of Oral Sodium Bicarbonate and Intravenous Hyoscine Butylbromide for Facilitating Natural Childbirth in Pregnant Women Induced for Labor
This trial is taking place in Norway and is studying ways to help pregnant women who are being induced to deliver their babies naturally without needing surgery. The study is expected to continue until early 2025.
Main inclusion criteria: Participants must be first-time mothers who are undergoing induction of labor. They must be carrying a single baby who is in a head-down position and must be at full term (close to their due date).
Main exclusion criteria: Women cannot participate if they are not currently pregnant, have any medical condition that might interfere with the study, are unable to give informed consent, or are part of a vulnerable population such as those who cannot make decisions for themselves.
Focus of the trial: The study aims to see if these treatments can help women who are being induced to go into labor deliver their babies naturally, without needing a cesarean section or other surgical methods such as vacuum or forceps delivery. The trial is designed to be double-blind, meaning neither the participants nor the researchers know who is receiving the actual treatment or the placebo, to ensure unbiased results. Participants are randomly assigned to one of four groups, with some receiving the actual treatments and others receiving a placebo.
Investigational drugs: The trial is testing two treatments: oral sodium bicarbonate (commonly known as baking soda) given as 500 mg capsules, which works by balancing acid levels in the body and may help uterine muscles work better during labor; and intravenous hyoscine butylbromide (also known as Buscopan) given as a 20 mg/ml solution, which works by relaxing smooth muscles and may help ease contractions during labor.
Summary
These two clinical trials represent ongoing efforts to improve labor induction practices across Scandinavia. The Swedish study focuses on the practical question of whether labor induction can be safely moved from hospital to home settings, which could significantly impact how healthcare services are delivered and improve patient comfort. The Norwegian trial takes a different approach by investigating medications that might facilitate natural delivery in women undergoing induction, potentially reducing the need for surgical interventions.
Both studies reflect a patient-centered approach to improving childbirth experiences, with one focusing on the setting of care and the other on optimizing the likelihood of vaginal delivery. The medications being tested represent different mechanisms of action, from cervical ripening with prostaglandins to muscle relaxation with antispasmodics, demonstrating the varied approaches researchers are taking to address challenges in labor induction.
