Outpatient Induction of Labor With Oral Misoprostol (NCT05144048) | Clinical Trial Compass
CompletedNot Applicable
Outpatient Induction of Labor With Oral Misoprostol
Norway302 participantsStarted 2022-01-01
Plain-language summary
Induction of labor is an increasingly used intervention in obstetrics due to expanding indications, which more often includes relatively healthy women with uncomplicated pregnancies. While induction of labor traditionally is offered in an inpatient setting, a shift towards an outpatient setting is increasing despite insufficient evidence regarding safety and effectiveness. Oral misoprostol is easy for the pregnant women to administer and the risk of uterine hyperstimulation with fetal heart rate changes is found to be low. Strong evidence concludes that oral misoprostol is preferable as an induction agent and is recommended by the World Health Organization (WHO).
The investigators will perform a multicenter randomized-controlled trial comparing labor induction in an outpatient versus inpatient setting, aiming to increase knowledge on outpatient induction of labor with oral misoprostol. The study is based on experiences and findings from a recently performed pilot trial and targets a large group of relatively healthy pregnant women where induction of labor is decided.
The investigators hypothesize that women induced in an outpatient setting will be more satisfied than women induced in an inpatient setting.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ≥ 37 gestational weeks, vertex presentation, single pregnancy
* Age ≥ 18 years
* Understand and read Norwegian
* Distance to hospital less than 1 hour
* Normal ultrasound including:
* fetal movements
* amniotic fluid (deepest single vertical pocket) \> 2 cm
* estimated fetal weight ≥ -15% (≥ 10 percentile)
* Normal antenatal cardiotocography
* Women with stable hypertension and uncomplicated preeclampsia without indication for inpatient treatment can be included after individual assessment.
* Access to partner or contact person at home for transportation to hospital
Exclusion Criteria:
* Premature rupture of membranes
* Uterine scar
* BMI ≥ 40
* Abnormal fetal Doppler (if examined); umbilical artery pulsatility index ≥ 95 percentile and/or cerebroplacental ratio \<1
* Fetal anomaly or chromosomic / genetic disorder
* Grand multipara (P≥4)
* Cognitive barriers
* Pregnancy complications such as preeclampsia requiring in-hospital treatment, insulin dependent diabetes or other conditions associated with risk of fetal hypoxia during labor
* Signs of infection or serious health problems
* Favorable cervix and / or previous obstetric history providing contraindications for induction with misoprostol
* Combined risk factors, individually evaluated by the attending obstetrician
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maternal childbirth experience and maternal experience with induction of labor