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

Primary Purpose

Fetal Growth Retardation

Status
Recruiting
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Cook´s balloon
Vaginal dinoprostone
Sponsored by
Hospital Universitario 12 de Octubre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fetal Growth Retardation focused on measuring Fetal Growth Restriction, Cervical Ripening, Cook's Balloon, Dinoprostone, Labor Induction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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: 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. Exclusion Criteria: Major fetal malformation Fetal genetic abnormality Fetal congenital infection

Sites / Locations

  • Hospital Sant Joan de Déu
  • Hospital Clinic i ProvincialRecruiting
  • Hospital Universitario 12 de OctubreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cook´s balloon

Vaginal dinoprostone

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Induction-to-delivery interval
Comparison of the time interval between the onset of cervical ripening and delivery between the two arms
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).

Full Information

First Posted
March 7, 2023
Last Updated
April 23, 2023
Sponsor
Hospital Universitario 12 de Octubre
Collaborators
Spanish Clinical Research Network - SCReN, Instituto de Salud Carlos III
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1. Study Identification

Unique Protocol Identification Number
NCT05774236
Brief Title
Cook´s Balloon Versus Dinoprostone for Labor Induction of Term Pregnancies With Fetal Growth Restriction
Acronym
COLIGROW
Official Title
Cook´s Balloon Versus Dinoprostone for Labor Induction of Term Pregnancies With Fetal Growth Restriction (COLIGROW)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 27, 2023 (Actual)
Primary Completion Date
May 27, 2025 (Anticipated)
Study Completion Date
September 27, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario 12 de Octubre
Collaborators
Spanish Clinical Research Network - SCReN, Instituto de Salud Carlos III

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Growth Retardation
Keywords
Fetal Growth Restriction, Cervical Ripening, Cook's Balloon, Dinoprostone, Labor Induction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
multicenter, randomized (1:1), open-label, 2-arm parallel group, controlled trial
Masking
None (Open Label)
Masking Description
No masking
Allocation
Randomized
Enrollment
172 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cook´s balloon
Arm Type
Experimental
Arm Description
Silicone 80 mL double-balloon cervical ripening catheter with an adjustable-length malleable stylet
Arm Title
Vaginal dinoprostone
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cook´s balloon
Other Intervention Name(s)
Cook® Cervical Ripening Balloon with Stylet, Double balloon catheter
Intervention Description
Cervical ripening for induction of labor with a mechanical method (Cook´s balloon)
Intervention Type
Drug
Intervention Name(s)
Vaginal dinoprostone
Other Intervention Name(s)
Dinoprostone vaginal insert, Controlled-release dinoprostone delivery system, Vaginal prostaglandin E2
Intervention Description
Cervical ripening for induction of labor with a pharmacological method (vaginal dinoprostone)
Primary Outcome Measure Information:
Title
Rate of vaginal delivery
Description
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.
Time Frame
2 days (from admission to delivery)
Secondary Outcome Measure Information:
Title
Rate of cesarean sections due to suspected fetal distress
Description
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
Time Frame
2 days (from admission to delivery)
Title
Induction-to-delivery interval
Description
Comparison of the time interval between the onset of cervical ripening and delivery between the two arms
Time Frame
2 days (from admission to delivery)
Title
Neonatal morbidity
Description
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).
Time Frame
From delivery to discharge of the newborn (up to 1 month)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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. Exclusion Criteria: Major fetal malformation Fetal genetic abnormality Fetal congenital infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ignacio Herraiz, MD, PhD
Phone
+34913908310
Email
ignacio.herraiz@salud.madrid.org
Facility Information:
Facility Name
Hospital Sant Joan de Déu
City
Esplugues de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edurne Mazarico, MD, PhD
Email
emazarico@sjdhospitalbarcelona.org
Facility Name
Hospital Clinic i Provincial
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Meler, MD, PhD
Email
emeler@clinic.cat
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ignacio Herraiz, MD, PhD
Email
ignacio.herraiz@salud.madrid.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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