ow-molecular-weight heparin in constituted vascular intrauterine growth restriction.

Phase 1

• Conditions: Intrauterine growth restriction (IUGR); MedDRA version: 20.0Level: LLTClassification code 10022819Term: Intrauterine growth retardationSystem Organ Class: 100000004868; MedDRA version: 20.0Level: LLTClassification code 10048489Term: Intrauterine growth retardSystem Organ Class: 100000004868; MedDRA version: 20.0Level: LLTClassification code 10048488Term: Growth intrauterine retardSystem Organ Class: 100000004868; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2016-000424-25-FR
• Lead Sponsor: CHU Saint-Etienne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-08
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 162

Inclusion Criteria

Patient over 18 years at > 22 and 34 weeks of gestation (WG) with vascular IUGR defined by :
- estimated fœtal weight below the 10th percentile
- clinical and ultrasound findings suggesting pathologically impaired growth or diminished fœtal well-being
- clinical and ultrasound findings suggesting placental insufficiency

Precise dating of pregnancy by ultrasound between 11 WG and 13 WE +6days
Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 162
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Multiple pregnancy or identified cause of IUGR other than vascular
- Patient with an immediate indication for fœtal extraction
- Women with a history of venous thromboembolism or already treated with an anticoagulant
- Women with contraindication to enoxaparin treatment at prophylactic doses
Patient refusing to participate or unable to consent
Platelet count < 80,00 platelets/mm3 at the initial assessment
Patient denying self injection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To assess the impact of treatment with enoxaparin in constituted vascular IUGR on : <br>- resistance parameters observed on fœtal doppler examinations<br>- fœtal growth kinetics<br>- major and minor neonatal parameters<br><br>To assess the safety of treatment with enoxaparin<br><br>To assess predictif factors to a birth weight below the 10th percentile;Main Objective: Evaluate the effectiveness of treatment with enoxaparin 4000 anti-Xa IU/day administred from the diagnosis of vascular IUGR up to 36 weeks of gestation, or delivery in reducing the number of newborns with a birth weight below the 10th percentile;Primary end point(s): Number of newborns with a birth weight below the 10th percentile according the AUDIPOG formula (http://www.audipog.net/courbes_morpho.php). This formula calculates the exact birth weight percentile from gestational age at birth, sex of newborn and birth weight;Timepoint(s) of evaluation of this end point: delivery

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1- Resistance parameters are : <br>1a- doppler examination of uterine arteries : pulsatility index, presence of unilateral or bilateral notch<br>1b - Umbilical doppler : resistance index, presence of zero diastole or reverse flow<br>2- Calculation of growth kinetics : birth weight by ultrasound<br>3- Major neonatal parameters measured are : perinatal death, ischaemic encephalopathy, major intra- or perivcentricular bleeding (grade 3 or 4) <br>4- Minor neonatal parameters measured are : caesarean section for fœtal distress, cord arterial pH<7.1, Apgar score <7 at 5 minutes, change in neonatal intensive care<br>5- Potential toxicity of the treatment : major or minor maternal bleeding event, cutaneous intolerance reaction, Thrombocytopenia, spontaneous bone pain, spontaneous fracture;Timepoint(s) of evaluation of this end point: Secondary endpoints 1 and 2 : change between initial ultrasound and follow-up ultra-sound<br>Secondary endpoints 3 and 4 : birth and 1 month of life