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NCT03528967: PRESANCE
Enoxaparin in the Prevention of Placental Insufficiency in Pregnant Women
Phase 4 trial testing Enoxaparin 40 mg / 0.4 mL Prefilled Syringe in Placental Insufficiency in 89 participants. Completed in 31 July 2018.
31 July 2018
Quick facts
| Lead sponsor | Les Laboratoires des Médicaments Stériles |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 89 |
| Start date | 23 October 2013 |
| Primary completion | 31 July 2018 |
| Estimated completion | 31 July 2018 |
| Sites | 1 location across Tunisia |
Drugs / interventions tested
- Enoxaparin 40 mg / 0.4 mL Prefilled Syringe — full drug profile →
- Aspirin 100 mg Oral Tablet, Enteric Coated — full drug profile →
Conditions studied
- Placental Insufficiency — all drugs for Placental Insufficiency →
- Enoxaparin — all drugs for Enoxaparin →
Sponsor
Les Laboratoires des Médicaments Stériles — full company profile →
Who can join
Adults 18 to 45, female only, with Placental Insufficiency or Enoxaparin. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03528967
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Placental Insufficiency
Currently open trials in the same condition.
- NCT05423665 — Speckle Tracking Echocardiography as a Tool for Early Diagnosis of Impaired Fetal Growth Twin Pregnancies · recruiting
Other Les Laboratoires des Médicaments Stériles trials
Trials by the same sponsor.
- NCT06999551 — Comparison of the Efficacy and Safety of GLARGEN® Versus NPH Insulin in Diabetic Tunisian Patients. · Phase 4 · not yet recruiting
- NCT06862726 — Apixaban Versus Rivaroxaban in Non Valvular Atrial Fibrillation · Phase 4 · enrolling by invitation
- NCT06503965 — Tunisian Registry of Trans Catheter Aortic Valve Implantation · recruiting
- NCT05603130 — Epidemiologic Register on Diabetes and COVID-19 in Tunisia · completed
- NCT04607239 — The Impact of Telemonitoring in the Management of Hypertension · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03528967 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Les Laboratoires des Médicaments Stériles
- Last refreshed: 2 July 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03528967.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing