An observational type study evaluating two anticoagulant drugs in the treatment of recurrent pregnancy loss caused by autoimmune factors

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2100046209

Enrollment

Unknown

Registered

2021-05-10

Start date

2021-05-16

Completion date

Unknown

Last updated

2021-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Repeated pregnancy loss

Interventions

Experimental GroupA:Fondaparinux

Experimental GroupB:Low molecular weight heparin sodium

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for repeated pregnancy loss (2017 ESHRE diagnostic criteria): 2 or more pregnancy losses before 24 weeks. Pregnancy is defined as serum or urine HCG positive, including biochemical pregnancy and unspecified pregnancy, but need to exclude ectopic pregnancy and mole; 2. Meet the diagnostic criteria for at least one of the diseases of systemic lupus erythematosus (SLE), antiphospholipid antibody syndrome (APS), undifferentiated connective tissue disease (UCTD), and Sjogrens syndrome (SS) (see Annex 1 for details) ; 3. The patient and (or) family members agree to join the clinical trial and sign an informed consent form..

Exclusion criteria

Exclusion criteria: 1. Combined with serious diseases of other systems, such as cardiovascular and cerebrovascular diseases (such as uncontrolled severe hypertension, blood pressure > 160/110 mmHg), liver disease (transaminase > 2 x ULN), blood system disease (platelet count 1.5 x ULN), infectious diseases, and surgical diseases such as appendicitis, cholecystitis, and intestinal obstruction; 2. The recent use of anticoagulant drugs or fibrinolytic drugs, high bleeding risk (cerebral ischemia, intracerebral hemorrhage or gastrointestinal hemorrhage for nearly 6 months, neurosurgery or other surgical procedures for nearly 1 month, active peptic ulcer ), international normalized ratio (INR) or activated partial thromboplastin time (APTT) prolonged; 3. History of allergy to heparin; 4. Have a history of thrombocytopenia caused by heparin; 5. Subjects participating in other clinical trials at the same time.

Design outcomes

Secondary

Measure	Time frame
Birth defect;Complications during pregnancy;	—

Primary

Measure	Time frame
Abortion rate;Live birth rate;	—

Countries

China

Contacts

Public ContactXiang Huifen

The First Affiliated Hospital of Anhui Medical University

sznfm2016@126.com+86 15255478660

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026