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

NCT05774236 | Completed Phase 3

• 4 other identifiers: COLIGROW2021-001726-22PI19_010052024-513523-16-00
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Fetal Growth Retardation

Keywords

Fetal Growth Restriction; Cervical Ripening; Cook's Balloon; Dinoprostone; Labor Induction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Rate of cesarean sections due to suspected fetal distress

  2 days (from admission to delivery)

• Induction-to-delivery interval

  2 days (from admission to delivery)

• Neonatal morbidity

  From delivery to discharge of the newborn (up to 1 month)

Study Arms (2)

Cook´s balloon

EXPERIMENTAL

Silicone 80 mL double-balloon cervical ripening catheter with an adjustable-length malleable stylet

Device: Cook´s balloon

Vaginal dinoprostone

ACTIVE COMPARATOR

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

Interventions

Cook´s balloon DEVICE

Cervical ripening for induction of labor with a mechanical method (Cook´s balloon)

Also known as: Cook® Cervical Ripening Balloon with Stylet, Double balloon catheter

Cook´s balloon

Vaginal dinoprostone DRUG

Cervical ripening for induction of labor with a pharmacological method (vaginal dinoprostone)

Also known as: Dinoprostone vaginal insert, Controlled-release dinoprostone delivery system, Vaginal prostaglandin E2

Vaginal dinoprostone

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Estimated fetal weight (EFW) \< 3rd percentile
• 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.

You may not qualify if:

• Major fetal malformation
• Fetal genetic abnormality
• Fetal congenital infection

Sponsors & Collaborators

• Hospital Universitario 12 de Octubre: lead
• Spanish Clinical Research Network - SCReN: collaborator
• Instituto de Salud Carlos III: collaborator

Study Sites (5)

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Hospital Clinic i Provincial

Barcelona, 08028, Spain

Location

Hospital Universitari Vall d&#39;Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Clinico Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

Location

Related Publications (1)

• Herraiz I, Meler E, Mazarico E, Bonacina E, Blanco JE, Villalain C, Barbero P, Peguero A, Barbera A, Sanchez ML, Llorente Munoz I, Lora Pablos D, Figueras F, Galindo A. Cook's balloon versus dinoprostone for Labour induction of term pregnancies with fetal GROWth restriction: study protocol for a randomised controlled trial in tertiary maternity hospitals in Spain (COLIGROW study). BMJ Open. 2024 Sep 30;14(9):e089628. doi: 10.1136/bmjopen-2024-089628.

  PMID: 39349375 DERIVED

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct professor

Model Details: multicenter, randomized (1:1), open-label, 2-arm parallel group, controlled trial

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 17, 2023
• Study Start: March 27, 2023
• Primary Completion: May 23, 2025
• Study Completion: May 26, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: From the time of publication and for 5 years thereafter
• Access Criteria: Upon request of investigators whose proposed research has received IRB approval and after data use agreement

Locations

ES (5)