NCT06531525

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

• Pregnancy Related
• Protein S Deficiency

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2024-08-01
• Last updated: 2024-08-01

Locations

1 site across 1 country: China