Enoxaparin in the Prevention of Placental Insufficiency in Pregnant Women (NCT03528967) | Clinical Trial Compass
CompletedPhase 4
Enoxaparin in the Prevention of Placental Insufficiency in Pregnant Women
Tunisia89 participantsStarted 2013-10-23
Plain-language summary
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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of maternal death
Timeframe: 7 - 42 weeks of amenorrhea
2
Recurrence rate of preeclampsia
Timeframe: 7 - 42 weeks of amenorrhea
3
Incidence of intrauterine growth restriction (IUGR)