A Phase 2 interventional study of Enoxaparin and Aspirin in Pregnancy Related and Protein S Deficiency, sponsored by Peking University People's Hospital. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-08-01.
Sponsored by Peking University People's Hospital · Phase 2, Interventional, and Prevention
To evaluate whether low molecular heparin could improve pregnancy outcomes in pregnancies with protein S deficiency.
This is a parallel-group, multicenter, randomized controlled trial of 48 pregnancies with protein S deficiency in China. Patients are randomized into three groups to receive enoxaparin combined with aspirin, aspirin alone and no intervention. The primary outcome measure is livebirth rate.
Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects randomized to the combination group will receive daily injections of enoxaparin at a dose of 4000 IU and aspirin 75mg per day orally until delivery.
Drug: Enoxaparin · Drug: Aspirin
Aspirin will be given at a dose of 75mg, orally, each day until delivery.
Drug: Aspirin
No intervention
Participants in all groups will receive daily injections of enoxaparin at a dose of 4000 IU within 6 weeks at postpartum.
Drug: Enoxaparin
Enoxaparin 4000 IU/day by subcutaneous injection at the time of randomization and continued until delivery. Dose adjustments were made throughout the study based on symptoms such as bleeding and thrombosis.
Also known as: lovenox, clexane
Aspirin 75mg, orally, once daily at the time of randomization and continued until delivery. Dose adjustments were made throughout the study based on symptoms such as bleeding and thrombosis.
Also known as: ASA
Participants in all groups will receive daily injections of enoxaparin at a dose of 4000 IU within 6 weeks at postpartum.
Also known as: lovenox, clexane
Rate of livebirth
Incidents of livebirth
Time frame: From date of randomization until delivery, assessed up to 42 months
Parameters of maternal coagulation-related indicators
D-Dimer in ng/ml, Protein S activity in %
Time frame: From the start of study treatment to 6 weeks post-partum
Parameters to assess the safety of low molecular heparin
Maternal platelet count in 10\^9/L, Number of haemorrhagic events, Number of cases of skin reactions at injection site
Time frame: From the start of study treatment to 6 weeks post-partum
Other incidents of adverse pregnancy outcomes
early miscarriage (until 12 weeks of gestation), late miscarriage (12-28 weeks of gestation), premature livebirths (28-37 weeks of gestation)
Time frame: up to 37 weeks
Neonatal Data
Neonatal weight in grams, Neonatal length in centimetres, Apgar 1-minute, 5-minute, 10-minute scores in scores, Number of neonatal complications
Time frame: after the delivery (an expected average of one month)
Incidents of placental insufficiency
Incidents of pre-eclampsia, intrauterine growth retardation, placental abruption, and intrauterine foetal death, etc.
Time frame: up to 6 weeks post-partum
Incidents of thrombosis/thromboembolism
thrombosis/thromboembolism
Time frame: From the start of study treatment to 6 weeks post-partum
This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Peking University People's Hospital