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NOT YET RECRUITING
NCT06531525
PHASE2

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

Sponsor: Peking University People's Hospital

View on ClinicalTrials.gov

Summary

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

Official title: A Multicenter, Open-label, Randomized, Controlled, Phase 2 Trial Evaluating Whether Low Molecular Heparin Could Improve Pregnancy Outcomes With Protein S Deficiency

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2024-08-01

Completion Date

2027-12-31

Last Updated

2024-08-01

Healthy Volunteers

No

Interventions

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.

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.

DRUG

Enoxaparin

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

Locations (1)

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

Beijing, Beijing/Beijing, China