Diagnosis and Treatment Strategy of Recurrent Spontaneous Abortion Associated With Thrombophilla

Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine

In this clinical cohort study, the investigators observe the efficacy of low molecular weight heparin in the treatment of thrombophilia with recurrent pregnancy loss with a prospective randomized controlled trial.

Study Overview

• Status: Unknown
• Conditions: Thrombophilia With Recurrent Pregnancy Loss
• Intervention / Treatment: Drug: Aspirin; Drug: Heparin

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200051
    • Recruiting
    • Shanghai first Maternity and Infant health hospital, Tong Ji University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Woman who had their Second miscarriage before 12(th) week of gestation.The patient who is diagnosed as thrombophilia with recurrent pregnancy loss. Signed consent form.

Exclusion Criteria:

1. having experiencedsevere allergies, trauma history and/or operation history within 3 months
2. with a history of mental illness and/or family history of mental illness
3. limb disabled
4. taking medicine within one month
5. suffering major events or having mood swings
6. with a history of recurrent pregnancy loss
7. having internal and surgical disease(after having variety of physical examination such as electrocardiogram/hepatic and renal function/blood routine and urine rotine)
8. Chromosome aberrations in anyone of the couple.
9. patients who have drug contraindications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: aspirin group; low dose aspirin, 75-100mg, bid, after pregnancy	Drug: Aspirin
EXPERIMENTAL: low molecular weight heparin group; low molecular weight heparin, 4100u, qd, after pregnancy	Drug: Heparin
EXPERIMENTAL: combination group; low molecular weight heparin, 4100u, once a day and low dose aspirin, 75-100mg, bid. After pregnancy	Drug: Aspirin; Drug: Heparin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
D-Dimer	through study completion, an average of 3 year

Secondary Outcome Measures

Outcome Measure	Time Frame
BMI in kg/m^2	through study completion, an average of 3 year

Collaborators and Investigators

• Sponsor: Shanghai First Maternity and Infant Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (ANTICIPATED): October 1, 2019
• Study Completion (ANTICIPATED): October 1, 2019

Study Registration Dates

• First Submitted: November 27, 2016
• First Submitted That Met QC Criteria: December 6, 2016
• First Posted (ESTIMATE): December 8, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): December 9, 2016
• Last Update Submitted That Met QC Criteria: December 8, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Thrombophilia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Anticoagulants; Aspirin; Heparin
• Other Study ID Numbers: ShanghaiFIMH-0002