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Cook´s balloon versus dinoprostone for Labor Induction of term pregnancies with fetal GROWth restriction (COLIGROW study)
EU CTIS ID: 2024-513523-16-00
What this study is testing
To assess whether cervical ripening with a Cook's ballon for induction of labor from week 37 + 0 of gestation in late intrauterine growth restriction increases the probability of vaginal delivery compared to the use of vaginal dinoprostone, without increasing neonatal morbidity.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Single gestation
- Age ≥ 18 years
- Gestational age dated by first trimester ultrasound ≥ 37 + 0 weeks at the moment of labor induction
- Cephalic presentation
- Stage I intrauterine growth restriction: presence of at least one of these two criteria: 1) Estimated fetal weight < percentile 3 2) Estimated fetal weight < percentile 10 and at least one of the following: - IP umbilical artery > percentile 95 - Cerebro-placental index < percentile 5
- Bishop score <7
You likely can't join if
- Fetal malformation
- Fetal genetic abnormality
- Congenital fetal infection
See the full eligibility criteria
- Single gestation
- Age ≥ 18 years
- Gestational age dated by first trimester ultrasound ≥ 37 + 0 weeks at the moment of labor induction
- Cephalic presentation
- Stage I intrauterine growth restriction: presence of at least one of these two criteria: 1) Estimated fetal weight < percentile 3 2) Estimated fetal weight < percentile 10 and at least one of the following: - IP umbilical artery > percentile 95 - Cerebro-placental index < percentile 5
- Bishop score <7
- Entire amniotic sac
- Non previous cesarean
- No contraindication for vaginal delivery or induction of labor
- Fetal malformation
- Fetal genetic abnormality
- Congenital fetal infection
The study team makes the final eligibility decision.
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, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.