Comparing Cook's Balloon and Dinoprostone for Inducing Labor in Pregnancies with Fetal Growth Restriction
Cook´s Balloon Versus Dinoprostone for Labor Induction of Term Pregnancies With Fetal Growth Restriction (COLIGROW)
This study is testing whether using a balloon or a medication is better for helping women with pregnancies affected by slow fetal growth to have a safe vaginal delivery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 172 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Hospital Universitario 12 de Octubre Academic / other |
| Locations | 3 sites (Esplugues de Llobregat, Barcelona and 2 other locations) |
| Trial ID | NCT05774236 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of two cervical ripening methods, Cook's balloon and vaginal dinoprostone, in singleton pregnancies with late-onset fetal growth restriction at term. Participants will be randomly assigned to receive either the mechanical method (Cook's balloon) or the pharmacological method (vaginal dinoprostone) to determine which approach leads to a higher rate of vaginal delivery without increasing neonatal morbidity. The study seeks to address the lack of randomized controlled trials on this topic and evaluate the safety and efficacy of these methods in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant individuals aged 18 and older with singleton pregnancies at or beyond 37 weeks gestation, presenting with late-onset fetal growth restriction.
Not a fit: Patients with major fetal malformations, genetic abnormalities, or congenital infections will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective method for inducing labor in pregnancies affected by fetal growth restriction, potentially reducing cesarean delivery rates.
How similar studies have performed: While there is limited published research on this specific comparison, the use of mechanical methods for cervical ripening has shown promise in other contexts, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Singleton pregnancy * Age ≥ 18 years * Gestational age (GA) dated by first trimester ultrasound ≥ 37+0 weeks * Cephalic presentation * Stage I fetal growth restriction, defined as the presence of at least one of these two criteria: 1. Estimated fetal weight (EFW) \< 3rd percentile 2. EFW \< 10th percentile and at least one of the following: 2.1) Umbilical artery pulsatility index \> 95th percentile or 2.2) Cerebral-placental index \< 5th percentile * Bishop score \< 7 * Intact fetal membranes * No previous caesarean section * No contraindications for vaginal delivery or labor induction. Exclusion Criteria: * Major fetal malformation * Fetal genetic abnormality * Fetal congenital infection
Where this trial is running
Esplugues de Llobregat, Barcelona and 2 other locations
- Hospital Sant Joan de Déu — Esplugues de Llobregat, Barcelona, Spain (Not_yet_recruiting)
- Hospital Clinic i Provincial — Barcelona, Spain (Recruiting)
- Hospital Universitario 12 de Octubre — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Ignacio Herraiz, MD, PhD
- Email: ignacio.herraiz@salud.madrid.org
- Phone: +34913908310
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.