Cook´s balloon versus dinoprostone for Labor Induction of term pregnancies with fetal GROWth restriction (COLIGROW study)

Phase 3

Recruiting

Conditions: Fetal growth restriction

Registration Number: 2024-513523-16-00

Lead Sponsor: Hospital Universitario 12 De Octubre

Brief Summary: 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.

Detailed Description: Late-onset fetal growth restriction (FGR) represents the most common subtype of FGR (70-80%). The greatest risk for these fetuses appears once term pregnancy is reached, when stressful situations are added to their status of relative hypoxia, such as the appearance of contractions and funicular compression. Thus, it has been shown that from week 37-38 the risk of intrauterine mortality increases and there is a general consensus not to prolong these pregnancies beyond this period. In this situation, induction of labor is usually preferred over elective caesarean delivery. However, these fetuses have an increased risk of cesarean section for suspected fetal distress.

Mechanical methods for cervical ripening are associated with less uterine stimulation with a lower rate of tachysystole than prostaglandins. Therefore, these methods have been proposed as the optimal approach for late-onset FGR, since they could reduce the rate of cesarean sections for suspected fetal distress. However, there is no published randomized controlled trials on the use of different methods of cervical ripening for labor induction in late-onset FGR.

Thus, the investigators postulate that, in late-onset FGR, cervical ripening with a mechanical method (Cook´s balloon) achieves a higher percentage of vaginal deliveries than a pharmacological method (vaginal dinoprostone), being safe for both the mother and the newborn.

The main aim of this study is to evaluate whether cervical ripening with Cook balloon for labor induction at term gestation of singleton pregnancies with late-onset FGR achieves a higher rate of vaginal delivery compared to the use of vaginal dinoprostone, without increasing neonatal morbidity.

Recruitment & Eligibility

Status: Ongoing, recruiting

Sex: Female

Target Recruitment: 172

Inclusion 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

Exclusion Criteria

Fetal malformation

Fetal genetic abnormality

Congenital fetal infection

Study & Design

Study Type: INTERVENTIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vaginal delivery; [yes/no]		Vaginal delivery; [yes/no]

Secondary Outcome Measures

Name	Time	Method
Rate of cesarean sections due to suspected fetal distress	2 days (from admission to delivery)	To assess whether cervical ripening with a Cook balloon for induction of labor of term pregnancies with FGR decreases the rates of cesarean sections due to suspected fetal distress with respect to the use of vaginal dinoprostone
Neonatal morbidity	From delivery to discharge of the newborn (up to 1 month)	To analyze the neonatal morbidity through the MAIN score (Morbidity assessment index for newborns) of neonatal morbidity and the duration of admissions to the Neonatal Intensive Care Unit (NICU).
Induction-to-delivery interval	2 days (from admission to delivery)	Comparison of the time interval between the onset of cervical ripening and delivery between the two arms

Trial Locations

Locations (5): Hospital Universitario 12 De Octubre
🇪🇸
Madrid, Spain
Hospital Clinic De Barcelona
🇪🇸
Barcelona, Spain
University Clinical Hospital Virgen De La Arrixaca
🇪🇸
Murcia, Spain
Sant Joan De Deu Barcelona Hospital
🇪🇸
Esplugues De Llobregat, Spain
Hospital Universitari Vall D Hebron
🇪🇸
Barcelona, Spain
Hospital Universitario 12 De Octubre
🇪🇸Madrid, Spain
Ignacio Herraiz García
Site contact
+34913908310
ignacio.herraiz@salud.madrid.org