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

Phase 1

Recruiting

Conditions: Fetal growth restriction
MedDRA version: 20.0Level: LLTClassification code: 10070532Term: Fetal growth restriction Class: 10036585
Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Registration Number: CTIS2024-513523-16-00

Lead Sponsor: Hospital Universitario 12 De Octubre

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: Compare the percentage of cesarean sections for suspected loss of fetal well-being., Study the length of time between the beginning of cervical ripening and the moment of delivery., Analyze neonatal outcomes: neonatal acidosis, MAIN score (morbidity assesment index for newborns) of neonatal morbidity and admissions to the Neonatal Intensive Care Unit.;Primary end point(s): Vaginal delivery; [yes/no]

Secondary Outcome Measures