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Fetal Growth RetardationPhase 3GROWTHNCT02672566

Low-molecular-weight Heparin in Constituted Vascular Intrauterine Growth Restriction

A Phase 3 study testing Enoxaparin in people with Fetal Growth Retardation, run by Centre Hospitalier Universitaire de Saint Etienne at 8 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Intrauterine growth restriction (IUGR) is correlated to an abnormal placenta development, with an alteration of the maternal-fetal circulation, coagulation troubles, and apparition of placental infarcts. IUGR represents the third cause of perinatal mortality in France, and is associated to an important morbidity. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Fetal Growth Retardation
What is being tested?
Enoxaparin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
8 sitesFrance
Study dates
22 Jul 2016to 22 Jan 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient over 18 years being at a gestational age ≥ 22 and <34 weeks of gestation with vascular fetal growth retardation defined according CNGOF
  • Ultrasound Estimated fetal weight below the 10th percentile
  • Clinical and ultrasound findings suggesting pathologically impaired growth or diminished foetal well-being
  • Clinical and ultrasound findings suggesting placental insufficiency
  • Precise dating of pregnancy with an ultrasound between 11 + 0 and 13 + 6 weeks of gestation
  • Written informed consent

Who cannot join

  • multiple pregnancy or identified cause of IUGR (intra-uterine growth retardation)
  • Patient with an immediate indication of fetal extraction
  • Women with a history of venous thromboembolism or already treated with anti-coagulant
  • Women with a contraindication to enoxaparin treatment at prophylactic doses
  • Patient refusing to participate or unable to consent
  • Patient with less than 80,000 platelets / mm 3 with the initial assessment

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

France8 sites

  • Chru Brest

    Brest

  • Chu Clermont-Ferrand

    Clermont-Ferrand, 63003

  • Chu Grenoble

    Grenoble, 38000

  • Ch Lyon Sud Pierre Benite

    Lyon

  • HFME - Lyon Est

    Lyon

  • Hopital Croix Rousse Lyon

    Lyon

  • Ch Roanne

    Roanne

  • Chu Saint Etienne

    Saint-Etienne, 42100

Other trials in France

About this study

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

Intrauterine growth restriction (IUGR) is correlated to an abnormal placenta development, with an alteration of the maternal-fetal circulation, coagulation troubles, and apparition of placental infarcts. IUGR 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. In 35% of cases, IUGR is of vascular origin and is included in the broader framework of placental vascular pathology (PVP).

Up to now, studies have focused on the primary or secondary prevention of PVP. Few studies have evaluated the treatment of constituted vascular IUGR. Currently, the management of vascular IUGR is mainly based on active surveillance, or termination of pregnancy. Pathological findings suggest that placental pro-thrombotic phenomena play a role in the constitution of vascular IUGR. Since aspirin is not effective in reducing this type of event, a randomized, open-label study conducted in China compared 14-day treatment with low-molecular-weight heparin (LMWH) versus Dan-Shen (a product not used in France) after diagnosis of IUGR. This trial, including 73 patients, showed a significant improvement in average growth kinetics in the LMWH group. The mean birth weight was 2877 g in the heparin group and 2492 g in the Dan-Shen group (p <0.0001). However, no data were provided concerning the number of newborns with a birth weight <10th percentile, i.e. the risk of morbidity and mortality, or complications occurring. Due to the lack of reliable data, LMWH are not included in the currently recommended therapeutic strategy for vascular IUGR.

The studies in IUGR reported to date mainly focused on primary or secondary prevention in women at risk of PVP, assessing the value of aspirin, which showed only a modest effect. No effective therapeutic strategy is available to treat patients with constituted vascular IUGR, a situation where LMWH should be more effective than antiplatelets given the vascular context.

Being tested
Enoxaparin, Usual care
Keywords
Fetal Growth Retardation, enoxaparin
Medical subject headings
Fetal Growth Retardation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnoxaparinDrug

    Also called Treatment

    Enoxaparin will be delivered to the patients every day at the dose of 4 000 Ui.

  • Usual careOther

    Also called Classic support

    Patients will all benefit from the usual care

Study groups in NCT02672566
Study groupRoleWhat they receive
Experimental group : enoxaparinExperimentalExperimental group will take enoxaparin (4000 Ui / Day) and will benefit from the usual care.
Receives: Drug: Enoxaparin; Other: Usual care
Control groupActive comparatorThe control group will only benefit from the usual care.
Receives: Other: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of new born with a weight inferior at the 10th percentile

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

    Measured: Week 36

Secondary outcomes (10)

  1. Change in doppler parameters of uterine arterie

    Doppler parameters is a composite outcome : pulsatility index and presence of notch

    Measured: baseline from delivery

  2. Change in doppler parameters of ombilical arterie

    Doppler parameters is a composite outcome : resistance index, presence of a zero diastole or reverse flow

    Measured: baseline from delivery

  3. Change in doppler fetal weight

    doppler fetal weight (grams)

    Measured: baseline from delivery

  4. birth weight

    birth weight (grams)

    Measured: delivery

  5. Number of new born with a weight inferior at the 3rd percentile

    With the AUDIPOG formula, the number of new born with a weight inferior at the 3rd percentile will be calculated.

    Measured: delivery

  6. Number of fetal extraction

    fetal extraction

    Measured: before 36 weeks of gestation

  7. number of major neonatal parameters

    Major neonatal parameters is at least one or more : Perinatal death, Ischemic encephalopathy Major intra- or periventricular bleeding (grade 3 or 4), Periventricular leukomalacia, Necrotizing enterocolitis, Bronchopulmonary dysplasia or Sepsis

    Measured: 1 month after delivery

  8. number of minor neonatal parameters

    Minor neonatal parameters is a composite outcome : Caesarean section for fetal distress, Cord arterial pH < 7.1, Apgar score <7 at 5 minutes

    Measured: 1 month after delivery

  9. Number of Major bleeding events (MB) and clinically relevant non-major bleeding events (CRNMB)

    The definitions of major bleeding events and clinically major bleeding events are adapted from the ISTH definition for which were added a specific Obstetrics and Gynaecology definition Bleeding events (MB) is a composite outcome.

    Measured: from randomisation to 1 month postpartum

  10. Number of thrombocytopenia

    thrombocytopenia is a composite outcome : Thrombopenia defined by platelet count < 100 G/L Significant thrombocytopenia with HIT suspicion defined as follows:≥ 40% decline of the platelet count (compared with baseline value) occurring during the first 8 weeks following the start of HBPM Or platelet count < 80 Giga/l to terme

    Measured: From randomisation to 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2016 (estimated)
  2. Study start22 Jul 2016
  3. Primary completion5 Sep 2019
  4. Study completion22 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02672566
Sponsor's protocol ID
1508175
Other IDs
2016-000424-25, 2016
Acronym
GROWTH
Status last verified
Apr 2019
First submitted
28 Jan 2016
Last updated
20 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Enoxaparin in people with Fetal Growth Retardation, run by Centre Hospitalier Universitaire de Saint Etienne at 8 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of new born with a weight inferior at the 10th percentile (time frame: Week 36). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02672566.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2020.

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