Early Versus Late Amniotomy During Labor Induction in Women With Bishop's Score of ≥ 6 (NCT04731896) | Clinical Trial Compass
CompletedNot Applicable
Early Versus Late Amniotomy During Labor Induction in Women With Bishop's Score of ≥ 6
Tunisia100 participantsStarted 2021-02-08
Plain-language summary
Labor induction is the stimulation of uterine contractions during pregnancy, before labor begins on its own to achieve a vaginal birth.
A health care provider might recommend labor induction for various reasons: primarily when there's concern for a mother's health or a baby's health.
Combined with oxytocin infusion, amniotomy is commonly used in the induction of labor. However the perfect timing of amniotomy is still unknown.
The aim of this study is to determine whether the early amniotomy followed by oxytocin, or initiating induction of labor with oxytocin followed by late amniotomy, is effective to reach active phase of labor.
Who can participate
Age range
18 Years – 48 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:
* Age ≥ 18 years old
* Full term (36 weeks and 3 days of gestation reached)
* Singletion gestation in cephalic presentation
* Bishop score of ≥ 6
Exclusion Criteria:
* Prior uterine surgery, previous cesarean section
* Ruptured membranes
* Spontaneous labor
* Multifetal pregnancy
* Dystocic presentation
* Fetal head not fixed at pelvic brim
* Macrosomia
* Hydramnios
* Severe fetal growth restriction
* Major fetal anomaly
* Women with HIV, hepatitis C, hepatitis B
* Women with medical conditions contraindication to a vaginal delivery
* Women with COVID-19 infection
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.