Fetal Growth RetardationPhase 3COLIGROWNCT05774236
Cook´s Balloon Versus Dinoprostone for Labor Induction of Term Pregnancies With Fetal Growth Restriction
A Phase 3 study testing Cook´s balloon and Vaginal dinoprostone in people with Fetal Growth Retardation, run by Hospital Universitario 12 de Octubre at 5 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fetal Growth Retardation
- What is being tested?
- Cook´s balloon and Vaginal dinoprostone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 5 sitesSpain
- Study dates
- 27 Mar 2023to 26 May 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- Major fetal malformation
- Fetal genetic abnormality
- Fetal congenital infection
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Hospital Clinic i Provincial
Barcelona, Barcelona, 08028
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, 08035
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona, 08950
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
Hospital Clinico Universitario Virgen de la Arrixaca
Murcia, Murcia, 30120
About this study
Official title: 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.
Read more
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. Neonatal outcomes (including neonatal acidosis, the MAIN morbidity score, and NICU admission) will be assessed as secondary, descriptive endpoints.
Read the 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. Neonatal safety outcomes (neonatal acidosis, the MAIN morbidity score, and NICU admission) will be analyzed as secondary endpoints, in a descriptive manner.
- Conditions
- Fetal Growth Retardation
- Being tested
- Cook´s balloon, Vaginal dinoprostone
- Keywords
- Fetal Growth Restriction, Cervical Ripening, Cook's Balloon, Dinoprostone, Labor Induction
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cook´s balloonDevice
Also called Cook® Cervical Ripening Balloon with Stylet, Double balloon catheter
Cervical ripening for induction of labor with a mechanical method (Cook´s balloon)
Vaginal dinoprostoneDrug
Also called Dinoprostone vaginal insert, Controlled-release dinoprostone delivery system, Vaginal prostaglandin E2
Cervical ripening for induction of labor with a pharmacological method (vaginal dinoprostone)
| Study group | Role | What they receive |
|---|---|---|
| Cook´s balloon | Experimental | Silicone 80 mL double-balloon cervical ripening catheter with an adjustable-length malleable stylet Receives: 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. Receives: Drug: Vaginal dinoprostone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 days (from admission to delivery)
Secondary outcomes (3)
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
Measured: 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
Measured: 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).
Measured: From delivery to discharge of the newborn (up to 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start27 Mar 2023
- Primary completion23 May 2025
- Study completion26 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fetal Growth RetardationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicenter, randomized (1:1), open-label, 2-arm parallel group, controlled trial
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario 12 de Octubre
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Clinical Research Network - SCReN, Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Ignacio Herraiz, Hospital Universitario 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774236
- Sponsor's protocol ID
- COLIGROW
- Other IDs
- 2021-001726-22, PI19_01005, 2024-513523-16-00
- Acronym
- COLIGROW
- Status last verified
- Jul 2026
- First submitted
- 7 Mar 2023
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 39349375
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cook´s Balloon Versus Dinoprostone for Labor Induction of Term Pregnancies With Fetal Growth Restriction (COLIGROW)
- ClinicalTrials.gov ID
- NCT05774236
- Acronym / sponsor ID
- COLIGROW / COLIGROW
- Conditions
- Fetal Growth Retardation
- Keywords
- Fetal Growth Restriction, Cervical Ripening, Cook's Balloon, Dinoprostone, Labor Induction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Hospital Universitario 12 de OctubreUniversity, hospital or other
- Collaborators
- Spanish Clinical Research Network - SCReN, Instituto de Salud Carlos III
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 23 May 2025 (actual)
- Study completion
- 26 May 2025 (actual)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. Neonatal outcomes (including neonatal acidosis, the MAIN morbidity score, and NICU admission) will be assessed as secondary, descriptive endpoints.
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. Neonatal safety outcomes (neonatal acidosis, the MAIN morbidity score, and NICU admission) will be analyzed as secondary endpoints, in a descriptive manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- multicenter, randomized (1:1), open-label, 2-arm parallel group, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Cook´s balloon | Experimental | Device: Cook´s balloonSilicone 80 mL double-balloon cervical ripening catheter with an adjustable-length malleable stylet |
| Vaginal dinoprostone | Active comparator | Drug: Vaginal dinoprostoneVaginal 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (3 listed)
- Major fetal malformation
- Fetal genetic abnormality
- Fetal congenital infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cook´s balloonAlso: Cook® Cervical Ripening Balloon with Stylet, Double balloon catheterCervical ripening for induction of labor with a mechanical method (Cook´s balloon) | Device | Cook´s balloon |
| Vaginal dinoprostoneAlso: Dinoprostone vaginal insert, Controlled-release dinoprostone delivery system, Vaginal prostaglandin E2Cervical ripening for induction of labor with a pharmacological method (vaginal dinoprostone) | Drug | Vaginal dinoprostone |
Primary outcome
Rate of vaginal delivery
Time frame: 2 days (from admission to 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.
3 secondary outcomes
Rate of cesarean sections due to suspected fetal distress
Time frame: 2 days (from admission to delivery)
Induction-to-delivery interval
Time frame: 2 days (from admission to delivery)
Neonatal morbidity
Time frame: From delivery to discharge of the newborn (up to 1 month)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Derived from this study: PubMed 39349375Herraiz 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.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cook´s balloon and Vaginal dinoprostone in people with Fetal Growth Retardation, run by Hospital Universitario 12 de Octubre at 5 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of vaginal delivery (time frame: 2 days (from admission to delivery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05774236, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.