Clinical Trial: Low-molecular-weight Heparin in Constituted Vascular Intrauterine Growth Restriction

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Low-molecular-weight Heparin in Constituted Vascular Intrauterine Growth Restriction. Randomized Multicenter Trial

Brief Summary:

Constituted vascular intrauterine growth restriction (CVIG) is correlated to an abnormal placenta development, with an alteration of the maternal-fetal circulation, coagulation troubles, and apparition of placental infarcts. CVIG represents the third cause of perinatal mortality in France, and is associated to an important morbidity. For birth-weights < 10th percentile of the gestational age, the neonatal death risk is doubled, compared to abnormal weights. 35% of CVIG are linked to vascular causes and are integrated in the placental vascular diseases.

To answer this objective, researchers propose a multicentric clinical trial, randomized, open, in two parallel groups, comparing the enoxaparin subcutaneous administration at preventive doses associated to the usual care (group 1) versus the usual care only (group 2). The inclusion of 81 patients per group is scheduled, meaning 162 patients in total. Participation for each patient starts at the first consultation until 1 month after delivery. Inclusion time is 22 months. Total duration is 26 months.


Detailed Summary:

Constituted vascular intrauterine growth restriction (CVIG) is correlated to an abnormal placenta development, with an alteration of the maternal-fetal circulation, coagulation troubles, and apparition of placental infarcts. CVIG represents the third cause of perinatal mortality in France, and is associated to an important morbidity. For birth-weights < 10th percentile of the gestational age, the neonatal death risk is doubled, compared to abnormal weights. 35% of CVIG are linked to vascular causes and are integrated in the placental vascular diseases.

Nowadays, studies are focused on prevention, with an efficacy limited for aspirin and heparin of low molecular weight (LMWH). Few studies have evaluated the treatments in CVIG cases. Aspirin did not show the efficacy in case of pathological uterine dopplers. Only one randomized study studied the LMWH at preventive doses during 14 days in the CVIG. In this open clinical trial including 73 patients, results were in favor for the heparin group : significantly improvement of the growth kinetic for fetus with a upper birth weight. These encouraging results suggest that LMWH are a physio-pathological treatment for CVIG and consequently, improve the intrauterine growth.

However, this preliminary data are insufficient. Basically, the CVIG support is based on an active watch with extraction in case of maternal or fetal suffering.

The primary objective is to evaluate the efficacy of the enoxaparin treatment at preventive doses (4 000 Ui/Day) administered during the CVIG diagnosis until the birth or at maximum 36 weeks of amenorrhea, to decrease the risk of new born with a weight birth < 10th percentile for the gestational age.

To answer this objective, researchers propose a multic
Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Current Primary Outcome: Number of new born with a weight inferior at the 10th percentile [ Time Frame: Week 36 ]

With the AUDIPOG formula, the number of new born with a weight inferior at the 10th percentile will be calculated.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Centre Hospitalier Universitaire de Saint Etienne

Dates:
Date Received: January 28, 2016
Date Started: June 2016
Date Completion: September 2018
Last Updated: June 2, 2016
Last Verified: June 2016