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Completed

NCT Number: NCT03528967

Enoxaparin in the Prevention of Placental Insufficiency in Pregnant Women

Assessment of the effectiveness of Enoxaparin, at a preventive dose, combined with Aspirin treatment versus Aspirin only treatment in reducing placental insufficiency in pregnant women.

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Key information

Conditions

Placental Insufficiency Enoxaparin Female Urogenital Diseases and Pregnancy Complications Placenta Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Maternity Center of Wassila Bourguiba Hospital - Department A

Tunis, Tunisia

About this study

Randomized, prospective, monocentric, open-label comparative study with two parallel groups (Enoxaparin, at a preventive dose, combined with Aspirin versus Aspirin alone), with the main objective being to evaluate the effectiveness of enoxaparin, at a preventive dose, in reducing placental insufficiency during pregnancy in pregnant women.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years and
  • Age ≤ 45 years and
  • Single and confirmed pregnancy and
  • Intrauterine growth restriction (IUGR) history with an estimated fetal weight (ESW) < 3rd percentile and / or
  • In utero fetal death (IUFD) history > 12 weeks of amenorrhea (WA) and / or
  • Central Retroplacental hematoma (RPH) history < 34 WA and / or
  • History of severe preeclampsia < 34 WA and
  • Informed consent, written and obtained

Exclusion criteria

  • Age <18 years or
  • Age > 45 years or
  • Multiple pregnancy or
  • Pregnancy > 7 WA or
  • Positive immunological assessment or
  • Known history of Thromboembolic diseases, Hemorrhagic diseases, Systemic Lupus Erythematosus (SLE), Heparin-induced thrombocythemia (HIT), Suspicion of thrombophilia (burdened history) or an episode of Deep Vein Thrombosis (DVT) or
  • Anticoagulation required or
  • Thrombocythaemia < 100,000 plq / µl or
  • Weight > 100 kg or
  • Osteoporosis or
  • Known allergy to the study products or
  • Inability to ensure injections' administration or
  • Family history of DVT before 40 years of age or

Treatment and study plan

Enoxaparin 40 mg / 0.4 mL Prefilled Syringe

Drug

Aspirin 100 mg Oral Tablet, Enteric Coated

Drug

Primary outcomes

  1. Incidence of maternal death

    Time frame: 7 - 42 weeks of amenorrhea

    To compare the incidence of maternal death between the two arms of the study.

  2. Recurrence rate of preeclampsia

    Time frame: 7 - 42 weeks of amenorrhea

    To compare the recurrence rate of preeclampsia between the two arms of the study.

  3. Incidence of intrauterine growth restriction (IUGR)

    Time frame: 7 - 42 weeks of amenorrhea

    To compare the incidence of IUGR between the two arms of the study.

  4. Incidence of retroplacental hematoma (RPH)

    Time frame: 7 - 42 weeks of amenorrhea

    To compare the incidence of RPH between the two arms of the study.

  5. Incidence of perinatal death

    Time frame: 7 - 42 weeks of amenorrhea

    To compare the incidence of perinatal death between the two arms of the study.

Secondary outcomes

  1. Incidence of miscarriage

    Time frame: 13 - 21 weeks of amenorrhea

    To compare the incidence of miscarriage between the two arms of the study.

  2. Incidence of in utero fetal death (IUFD)

    Time frame: 22 weeks of amenorrhea at birth

    To compare the incidence of IUFD between the two arms of the study.

  3. Incidence of neonatal death

    Time frame: From birth to 28 days of life

    To compare the incidence of neonatal death between the two arms of the study.

  4. Number of adverse events

    Time frame: 7 - 42 weeks of amenorrhea

    To compare the safety of both study products

Sponsors and collaborators

Lead sponsor

Les Laboratoires des Médicaments Stériles

Industry

Registry information

Official study title

Enoxaparine en PREvention Des insuffiSAnces Placentaires Chez Les Femmes eNCEintes

Acronym: PRESANCE

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
May 18, 2018
Registry last updated
Jul 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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