Authorised Therapeutic use (Phase IV) Fetal Growth Restriction

HepaGrowth

EU CTIS ID: 2024-516572-15-00

What this study is testing

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

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Age >= 18 years old
  • Able to provide consent
  • 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)

You likely can't join if

  • Multiple gestations
  • Maternal thrombocytopenia (platelets < 100 000)
  • History of maternal hemophilia or Von Willebrand disease
  • Presence of placental hematoma
  • Maternal diabetic retinopathy
  • Bacterial endocarditis
See the full eligibility criteria
Who can join
  • Age >= 18 years old
  • Able to provide consent
  • 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)
What rules you out
  • Multiple gestations
  • Maternal thrombocytopenia (platelets < 100 000)
  • History of maternal hemophilia or Von Willebrand disease
  • Presence of placental hematoma
  • Maternal diabetic retinopathy
  • Bacterial endocarditis
  • 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
  • Persistent blood pressure > 160/100 mmHg, despite optimal anti-hypertensive regimen
  • History of severe renal disease (eGFR <30mL/min)
  • Known or suspected hepatic impairment
  • Current participation in another clinical trial
  • Diagnosed fetal chromosomal abnormalities
  • Patients that are not part of the national health system (SNS)
  • Delivery already scheduled, or predicted in the next 7 days
  • Associated fetal morphological malformation
  • Evidence of fetal infection (serological or after invasive testing)
  • 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
  • Present use of systemic salicylates in anti-inflammatory dosage (> 150 mg/day) or NSAIDs (including ketorolac)
  • Maternal history of allergy to LMWH or non-fractionated heparin (NFH)
  • Hypersensitivity to pork products
  • Maternal history of heparin-induced thrombocytopenia

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.