Overview
Sponsor-declared trial summary
Fetal growth restriction
To assess whether cervical ripening with a Cook's ballon for induction of labor from week 37 + 0 of gestation in late intrauterine growth restriction increases the probability of vaginal delivery compared to the use of vaginal dinoprostone, without increasing neonatal morbidity.
Key facts
- Sponsor
- Hospital Universitario 12 De Octubre
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 16 Mar 2023 → 18 Dec 2025
- Decision date (initial)
- 2024-04-15
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Instituto de Salud Carlos III
External identifiers
- EU CT number
- 2024-513523-16-00
- EudraCT number
- 2021-001726-22
- ClinicalTrials.gov
- NCT05774236
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy, Efficacy
To assess whether cervical ripening with a Cook's ballon for induction of labor from week 37 + 0 of gestation in late intrauterine growth restriction increases the probability of vaginal delivery compared to the use of vaginal dinoprostone, without increasing neonatal morbidity.
Secondary objectives 3
- Compare the percentage of cesarean sections for suspected loss of fetal well-being.
- Study the length of time between the beginning of cervical ripening and the moment of delivery.
- Analyze neonatal outcomes: neonatal acidosis, MAIN score (morbidity assesment index for newborns) of neonatal morbidity and admissions to the Neonatal Intensive Care Unit.
Conditions and MedDRA coding
Fetal growth restriction
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10070532 | Fetal growth restriction | 10036585 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Multicentre phase III, randomized, controlled, open-label, superiority trial Multicentre randomized, controlled, open-label, superiority trial with two parallel groups
|
Randomised Controlled | None | Experimental - Cook´s balloon: Silicone 80 mL double-balloon cervical ripening catheter with an adjustable-length malleable stylet Control - 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. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- Single gestation
- Age ≥ 18 years
- Gestational age dated by first trimester ultrasound ≥ 37 + 0 weeks at the moment of labor induction
- Cephalic presentation
- Stage I intrauterine growth restriction: presence of at least one of these two criteria: 1) Estimated fetal weight < percentile 3 2) Estimated fetal weight < percentile 10 and at least one of the following: - IP umbilical artery > percentile 95 - Cerebro-placental index < percentile 5
- Bishop score <7
- Entire amniotic sac
- Non previous cesarean
- No contraindication for vaginal delivery or induction of labor
Exclusion criteria 3
- Fetal malformation
- Fetal genetic abnormality
- Congenital fetal infection
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Vaginal delivery; [yes/no]
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PROPESS 10 mg sistema de liberación vaginal
PRD474897 · Product
- Active substance
- Dinoprostone
- Pharmaceutical form
- VAGINAL DELIVERY SYSTEM
- Route of administration
- VAGINAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 20 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- G02AD02 — DINOPROSTONE
- Marketing authorisation
- 62.088
- MA holder
- FERRING S.A.U.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hospital Universitario 12 De Octubre
- Sponsor organisation
- Hospital Universitario 12 De Octubre
- Address
- Bloque D, Avenida De Cordoba Sn Avenida De Cordoba Sn
- City
- Madrid
- Postcode
- 28041
- Country
- Spain
Scientific contact point
- Organisation
- Hospital Universitario 12 De Octubre
- Contact name
- Ignacio Herraiz García
Public contact point
- Organisation
- Hospital Universitario 12 De Octubre
- Contact name
- Ignacio Herraiz García
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 172 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2023-03-16 | 2025-12-18 | 2023-03-21 | 2025-05-21 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-09 | Spain | Acceptable 2024-04-15
|
2024-04-15 |