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

Launched by PEKING UNIVERSITY PEOPLE'S HOSPITAL · Jul 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called low molecular heparin can help improve pregnancy outcomes for women who have a condition known as protein S deficiency. Protein S deficiency can increase the risk of blood clots during pregnancy, which can lead to complications. The trial aims to see if this medication can reduce those risks and support healthier pregnancies.

To be eligible for this trial, women must have low levels of protein S in their blood when not pregnant and during their pregnancy. They should also have a history of blood clot issues or a family history of similar problems. Participants will need to provide written consent and will be monitored throughout the study. It’s important to note that women with other specific health conditions or those allergic to the medication will not be able to participate. Overall, this trial offers a potential pathway for improved care for pregnant women facing challenges due to protein S deficiency.

Gender

FEMALE

Eligibility criteria

• 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
• • 8. Patients with diagnosis confirmed by gene analysis Inclusion criteria 1 and 2 must always be met regardless of items of 3-8.
• • 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