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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
48
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.
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.
Participants in all groups will receive daily injections of enoxaparin at a dose of 4000 IU within 6 weeks at postpartum.
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, Beijing/Beijing, China
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
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