BridgeMD
Compares treatment options for Fetal Growth Restriction
Official title Prostaglandins Versus Trans-cervical Balloon for Induction of Labor in Fetal Growth Restriction (PROBIN)
ClinicalTrials.gov ID: NCT05674487
What this study is testing
What is Misoprostol?
Misoprostol is an investigational medicine, being studied as a potential treatment for fetal growth restriction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this randomized trial is to compare two methods of induction in a fetal growth restriction population. The main question it aims to answer is: Is trans-cervical balloon superior to prostaglandins in reducing the cesarean section rate, without increasing neonatal morbidity?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Age over 18 years
- Singleton gestation, with cephalic presentation
- Gestational age at randomization between entre 34 weeks of gestation and 0 day and 41 weeks of gestation and 0 day
- Fetal growth restriction (FGR). FGR is defined at the third trimester by an abdominal circumference below the 10th centile and/or an estimated fetal...
- Plan for induction of labor whatever the indication (fetal growth restriction or other), the induction of labor is the induction of birth by vaginal...
You likely can't join if
- Contraindication to an induction of labor
- History of previous cesarean delivery, myomectomy by laparotomy or laparoscopy
- Contraindication to misoprostol or trans-cervical balloon
- Known HIV positivity (because of modified delivery plan)
- Known major fetal anomaly or chromosomic anomaly
- Fetal demise
See the full eligibility criteria
- Age over 18 years
- Singleton gestation, with cephalic presentation
- Gestational age at randomization between entre 34 weeks of gestation and 0 day and 41 weeks of gestation and 0 day
- Fetal growth restriction (FGR). FGR is defined at the third trimester by an abdominal circumference below the 10th centile and/or an estimated fetal weight below the 10th centile (according to local curve), according to...
- Plan for induction of labor whatever the indication (fetal growth restriction or other), the induction of labor is the induction of birth by vaginal delivery
- Bishop Score below 6
- Affiliated or beneficiary to a health security system
- Signed informed consent
- Contraindication to an induction of labor
- History of previous cesarean delivery, myomectomy by laparotomy or laparoscopy
- Contraindication to misoprostol or trans-cervical balloon
- Known HIV positivity (because of modified delivery plan)
- Known major fetal anomaly or chromosomic anomaly
- Fetal demise
- Patient under legal protection
- Poor understanding of the French language
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.