Effect of Low Molecular Heparin on Pregnancy Outcome With Protein S Deficiency

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2027-12-31

Brief Summary

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To evaluate whether low molecular heparin could improve pregnancy outcomes in pregnancies with protein S deficiency.

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Detailed Description

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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.

Conditions

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Pregnancy Related Protein S Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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The combination group

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.

Group Type EXPERIMENTAL

Enoxaparin

Intervention Type DRUG

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

Intervention Type DRUG

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.

The Aspirin group

Aspirin will be given at a dose of 75mg, orally, each day until delivery.

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

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.

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

All groups

Participants in all groups will receive daily injections of enoxaparin at a dose of 4000 IU within 6 weeks at postpartum.

Group Type OTHER

Enoxaparin

Intervention Type DRUG

Participants in all groups will receive daily injections of enoxaparin at a dose of 4000 IU within 6 weeks at postpartum.

Interventions

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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.

Intervention Type DRUG

Aspirin

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.

Intervention Type DRUG

Enoxaparin

Participants in all groups will receive daily injections of enoxaparin at a dose of 4000 IU within 6 weeks at postpartum.

Intervention Type DRUG

Other Intervention Names

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lovenox clexane ASA lovenox clexane

Eligibility Criteria

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Inclusion Criteria

1. Plasma activity levels of PS when not pregnant are below the lower limits of the adult reference values (generally about 60-70% for PS) without the use of warfarin. Or, free protein S antigen levels in the second and third trimesters are less than 30% and less than 24%, respectively
2. Pregnant women who delivered from Aug 1st, 2024 to Oct 15th, 2027
3. One or more family members exhibiting the same symptoms as the patient
4. Past history of early onset thrombosis (age 50 or below)
5. Repeated recurrence of thrombosis
6. Thromboses in unusual sites
7. New onset of thrombosis during current pregnancy or after delivery
9. Written informed consent

Exclusion Criteria

1. Thrombophilia other than Protein S deficiency
2. Antiphospholipid syndrome, systemic lupus erythematosus, platelet abnormalities, vascular disorders, blood flow obstruction, paroxysmal nocturnal hemoglobinuria, malignant tumor and other conditions that tend to cause thrombosis
3. Allergy/hypersensitivity to enoxaparin or aspirin
4. Heparin-associated thrombocytopenia or thrombocytopenia (platelet count\<75 × 10\^9/L)
5. Organ lesions at risk for bleeding such as acute stomach/bowel ulcers, cerebral hemorrhage, cerebral aneurysm
6. uncontrolled hypertension or Severe hypertension (Systolic Blood Pressure \>200mmhg and/or Diastolic Blood Pressure \>120mmHg)
7. Severe hepatic failure (INR \>1.8)
8. Serum creatinine greater than 80 umol/L (1.3mg/dl) and an abnormal 24 hour urine creatine clearance (\<30ml/min)
9. Abnormal uterine cavity on hysterosalpingogram/hysteroscopy

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No