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

NCT06531525 | Not Yet Recruiting Phase 2

• 1 other identifier: PKU-PS-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pregnancy Related; Protein S Deficiency

Keywords

Protein S Deficiency; pregnancy; therapy

Outcome Measures

Primary Outcomes (1)

• Rate of livebirth

  Incidents of livebirth

  From date of randomization until delivery, assessed up to 42 months

Secondary Outcomes (6)

• Parameters of maternal coagulation-related indicators

  From the start of study treatment to 6 weeks post-partum

• Parameters to assess the safety of low molecular heparin

  From the start of study treatment to 6 weeks post-partum

• Other incidents of adverse pregnancy outcomes

  up to 37 weeks

• Neonatal Data

  after the delivery (an expected average of one month)

• Incidents of placental insufficiency

  up to 6 weeks post-partum

Study Arms (4)

The combination group

EXPERIMENTAL

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

The Aspirin group

ACTIVE COMPARATOR

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

Drug: Aspirin

No intervention

NO INTERVENTION

No intervention

All groups

OTHER

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

Drug: Enoxaparin

Interventions

Enoxaparin 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.

Also known as: lovenox, clexane

The combination group

Aspirin 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.

Also known as: ASA

The Aspirin group; The combination group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Pregnant women who delivered from Aug 1st, 2024 to Oct 15th, 2027
• One or more family members exhibiting the same symptoms as the patient
• Past history of early onset thrombosis (age 50 or below)
• Repeated recurrence of thrombosis
• Thromboses in unusual sites
• New onset of thrombosis during current pregnancy or after delivery
• Written informed consent

You may not qualify if:

• Thrombophilia other than Protein S deficiency
• 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
• Allergy/hypersensitivity to enoxaparin or aspirin
• Heparin-associated thrombocytopenia or thrombocytopenia (platelet count\<75 × 10\^9/L)
• Organ lesions at risk for bleeding such as acute stomach/bowel ulcers, cerebral hemorrhage, cerebral aneurysm
• uncontrolled hypertension or Severe hypertension (Systolic Blood Pressure \>200mmhg and/or Diastolic Blood Pressure \>120mmHg)
• Severe hepatic failure (INR \>1.8)
• Serum creatinine greater than 80 umol/L (1.3mg/dl) and an abnormal 24 hour urine creatine clearance (\<30ml/min)
• Abnormal uterine cavity on hysterosalpingogram/hysteroscopy

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Beijing Obstetrics and Gynecology Hospital: collaborator
• Beijing Hospital: collaborator
• Peking Union Medical College Hospital: collaborator
• China-Japan Friendship Hospital: collaborator
• Sichuan Academy of Medical Sciences: collaborator
• Xiangya Hospital of Central South University: collaborator
• Chinese PLA General Hospital: collaborator
• Beijing Friendship Hospital: collaborator
• Beijing Chuiyangliu Hospital: collaborator

Study Sites (1)

Peking University Insititute of Hematology, Peking University People's Hospital

Beijing, Beijing/Beijing, 100010, China

Location

MeSH Terms

Conditions

Protein S Deficiency

Interventions

Enoxaparin; Aspirin

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Blood Protein Disorders; Thrombophilia

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Xiao-Hui Zhang, Professor

  Peking University Insititute of Hematology, Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao-Hui Zhang, Professor

CONTACT

+8613522338836; zhangxh100@sina.com

Meng-Tong Zang, MD

CONTACT

18744579871; zangztong@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of Peking University Institute of Hematology

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: August 1, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 1, 2024

Record last verified: 2024-07

Locations

CN (1)