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

NCT ID: NCT05774236

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-27
• Study Completion Date: 2025-05-26

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.

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.

Conditions

Fetal Growth Retardation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cook´s balloon

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

Group Type: EXPERIMENTAL

Cook´s balloon

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

Vaginal dinoprostone

Intervention Type: DRUG

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

Interventions

Cook´s balloon

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

Intervention Type: DEVICE

Vaginal dinoprostone

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

Intervention Type: DRUG

Other Intervention Names

Cook® Cervical Ripening Balloon with Stylet; Double balloon catheter; Dinoprostone vaginal insert; Controlled-release dinoprostone delivery system; Vaginal prostaglandin E2

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Spanish Clinical Research Network - SCReN

NETWORK

Sponsor Role: collaborator

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Hospital Universitario 12 de Octubre

OTHER

Sponsor Role: lead

Responsible Party

Ignacio Herraiz

Adjunct professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona, Spain

Hospital Clinic i Provincial

Barcelona, , Spain

Hospital Universitari Vall d&#39;Hebron

Barcelona, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Clinico Universitario Virgen de la Arrixaca

Murcia, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 39349375 (View on PubMed)

Other Identifiers

2021-001726-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PI19_01005

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024-513523-16-00

Identifier Type: CTIS

Identifier Source: secondary_id

COLIGROW

Identifier Type: -

Identifier Source: org_study_id