HepaGrowth

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Unidade Local De Saude De Sao Jose E.P.E.

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Trial duration

16 Sep 2024 → ongoing

Decision date (initial)

2024-09-16

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Fundo de Financiamento à Investigação, Unidade Local de Saúde São José · Bolsa da Sociedade Portuguesa de Obstetrícia e Medicina Materno-Fetal · Prémio Merk Sharp & Dome Investigação em Saúde · Prémio Maria de Sousa (Fundação Bial e Ordem dos Médicos)

External identifiers

EU CT number

2024-516572-15-00

EudraCT number

2020-000315-76

ClinicalTrials.gov

NCT04762992

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

To determine if enoxaparin increases the mean gestational age of delivery for ERF

Secondary objectives 9

1. To determine if enoxaparin decreases fetal and neonatal morbimortality
2. To determine if enoxaparin improves maternal and fetal Doppler parameters in this group of patients
3. To determine if enoxaparin is associated with alterations in placental pathology
4. To determine if enoxaparin is associated with alterations in Sflt1- PLGF ratio
5. To determine if there is a change in number or composition of STDEV between healthy and FGR pregnancies
6. To determine if enoxaparin is associated with alterations in STD-EV in FGR pregnancies
7. To investigate if enoxaparin decreases the incidence of hypertensive complications of pregnancy
8. To evaluate if enoxaparin is associated with an increased incidence of adverse effects during pregnancy, labor and post-partum
9. To evaluate if the clinical response to enoxaparin is dependent on maternal body mass index (BMI) at the moment of randomization

Conditions and MedDRA coding

Fetal Growth Restriction

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Age >= 18 years old
2. Able to provide consent
3. Having a viable singleton pregnancy with diagnosed early FGR confirmed in our unit according to the 2016 consensus criteria (Gordijn SJ, Beune IM, Thilaganathan B, Papageorghiou A, Baschat AA, Baker PN, et al. Consensus definition of fetal growth restriction: a Delphi procedure. Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology. 2016;48(3):333-9)

Exclusion criteria 21

1. Multiple gestations
2. Diagnosed fetal chromosomal abnormalities
3. Associated fetal morphological malformation
4. Evidence of fetal infection (serological or after invasive testing)
5. Use of LMWH or NFH in the index pregnancy before randomization or start of any of these medications for another indication if the patient is in the control group
6. Present use of systemic salicylates in anti-inflammatory dosage (> 150 mg/day) or NSAIDs (including ketorolac)
7. Maternal history of allergy to LMWH or non-fractionated heparin (NFH)
8. Hypersensitivity to pork products
9. Maternal history of heparin-induced thrombocytopenia
10. Maternal thrombocytopenia (platelets < 100 000)
11. History of maternal hemophilia or Von Willebrand disease
12. Presence of placental hematoma
13. Maternal diabetic retinopathy
14. Bacterial endocarditis
15. Active clinically significant bleeding and conditions with a high risk of hemorrhage, including recent hemorrhagic stroke, gastrointestinal ulcer, presence of malignant neoplasm at high risk of bleeding, recent brain, spinal or ophthalmic surgery, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities
16. Persistent blood pressure > 160/100 mmHg, despite optimal anti-hypertensive regimen
17. History of severe renal disease (eGFR <30mL/min)
18. Known or suspected hepatic impairment
19. Current participation in another clinical trial
20. Patients that are not part of the national health system (SNS)
21. Delivery already scheduled, or predicted in the next 7 days

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Gestational age at delivery

Secondary endpoints 17

1. Evolution of fetal Doppler parameters (umbilical artery pulsatility index, middle cerebral artery pulsatility index, cerebralplacental ratio, ductus venosus pulsatility index)
2. Evolution of maternal doppler parameters (uterine artery pulsatility index)
3. Maternal body mass index (BMI) at moment of randomization
4. Newborn weight, percentile, umbilical artery pH and Apgar score in the 5th minute
5. Neonatal intensive care admission and duration of admission
6. A composite outcome of severe neonatal morbidity (evidence of one or more of: intraventricular hemorrhage grade 3 or 4; cystic periventricular leukomalacia; chronic lung disease; retinopathy of prematurity requiring treatment; necrotizing enterocolitis requiring surgery)
7. Gestational hypertension or preeclampsia
8. Placental abruption
9. Antepartum hemorrhage
10. Maternal thrombocytopenia (platelets < 100 000 x 109/L)
11. Stillbirth
12. Mode of delivery
13. Indication for delivery
14. Postpartum hemorrhage
15. Placental pathology
16. sFLT1-PLGF ratio
17. Syncytiotrophoblast derived vesicles (STD-EVS)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Unidade Local De Saude De Sao Jose E.P.E.

Sponsor organisation

Unidade Local De Saude De Sao Jose E.P.E.

Address

Rua Jose Antonio Serrano

City

Lisbon

Postcode

1150-199

Country

Portugal

Scientific contact point

Organisation

Unidade Local De Saude De Sao Jose E.P.E.

Contact name

Catarina Palma dos Reis

Public contact point

Organisation

Unidade Local De Saude De Sao Jose E.P.E.

Contact name

Gabinete de Investigação ULS São José

Third parties 2

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications