Cook´s Balloon Versus Dinoprostone for Labor Induction of Term Pregnancies With Fetal Growth Restriction (COLIGROW)

Cook´s Balloon Versus Dinoprostone for Labor Induction of Term Pregnancies With Fetal Growth Restriction (COLIGROW)

The goal of this clinical trial is to compare how two methods for cervical ripening work in a population of singleton pregnancies with late-onset fetal growth restriction (FGR) at term.

The main question it aims to answer is whether Cook´s balloon (a mechanical method) is superior to vaginal dinoprostone (a pharmacological method) in achieving a vaginal delivery, without increasing neonatal morbidity.

Participants will be randomized to receive Cook´s balloon (experimental group) or vaginal dinoprostone (control group) for cervical ripening.

Researchers will compare both groups to see if Cook´s balloon is associated with a higher rate of vaginal delivery than vaginal dinoprostone and is not related to increased neonatal morbidity.

Study Overview

• Status: Completed
• Conditions: Fetal Growth Retardation
• Intervention / Treatment: Device: Cook´s balloon; Drug: Vaginal dinoprostone

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.

• Study Type: Interventional
• Enrollment (Actual): 172
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain, 08028
    • Hospital Clínic i Provincial
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Murcia, Spain, 30120
    • Hospital Clinico Universitario Virgen de la Arrixaca
  • Barcelona
    • Esplugues de Llobregat, Barcelona, Spain, 08950
      • Hospital Sant Joan de Déu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cook´s balloon; Silicone 80 mL double-balloon cervical ripening catheter with an adjustable-length malleable stylet	Device: Cook´s balloon; Cervical ripening for induction of labor with a mechanical method (Cook´s balloon); Other Names: Cook® Cervical Ripening Balloon with Stylet; Double balloon catheter
Active Comparator: Vaginal dinoprostone; Vaginal delivery system containing 10 mg dinoprostone (Prostaglandin E2) dispersed throughout its matrix and releasing approximately 0.3 mg/hour dinoprostone over a 24-hour period.	Drug: Vaginal dinoprostone; Cervical ripening for induction of labor with a pharmacological method (vaginal dinoprostone); Other Names: Dinoprostone vaginal insert; Controlled-release dinoprostone delivery system; Vaginal prostaglandin E2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of vaginal delivery	To assess whether cervical ripening with a Cook balloon for induction of labor of term pregnancies with FGR increases the rates of vaginal delivery with respect to the use of vaginal dinoprostone, without increasing neonatal morbidity.	2 days (from admission to delivery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of cesarean sections due to suspected fetal distress	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	2 days (from admission to delivery)
Induction-to-delivery interval	Comparison of the time interval between the onset of cervical ripening and delivery between the two arms	2 days (from admission to delivery)
Neonatal morbidity	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).	From delivery to discharge of the newborn (up to 1 month)

Collaborators and Investigators

• Sponsor: Hospital Universitario 12 de Octubre
• Collaborators: Instituto de Salud Carlos III; Spanish Clinical Research Network - SCReN

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2023
• Primary Completion (Actual): May 23, 2025
• Study Completion (Actual): May 26, 2025

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: March 7, 2023
• First Posted (Actual): March 17, 2023

Study Record Updates

• Last Update Posted (Actual): June 11, 2025
• Last Update Submitted That Met QC Criteria: June 6, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Cervical Ripening; Labor Induction; Fetal Growth Restriction; Dinoprostone; Cook's Balloon
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Fetal Diseases; Growth Disorders; Fetal Growth Retardation; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Dinoprostone
• Other Study ID Numbers: COLIGROW; 2021-001726-22 (EudraCT Number); PI19_01005 (Other Grant/Funding Number: Instituto de Salud Carlos III); 2024-513523-16-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified IPD that underlies the results reported in the publication will be shared after publications of primary results upon request of investigators whose proposed research has received IRB approval and after data use agreement
• IPD Sharing Time Frame: From the time of publication and for 5 years thereafter
• IPD Sharing Access Criteria: Upon request of investigators whose proposed research has received IRB approval and after data use agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No