The Novel Immunomodulatory and Anticoagulant Therapies for Recurrent Pregnancy Loss

Recurrent Pregnancy Loss Clinical Trial

Official title:

The Novel Immunomodulatory and Anticoagulant Therapies for Recurrent Pregnancy Loss

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02990403
• Other study ID #: ShanghaiFMIH-0003
• Status: Recruiting
• Phase: Phase 4
• First received: December 7, 2016
• Last updated: March 6, 2017
• Start date: October 2014
• Est. completion date: December 22, 2018

Study information

• Verified date: December 2016
• Source: Shanghai First Maternity and Infant Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this clinical cohort study, the investigators are going to observe the efficacy of anti-coagulation and immune therapy in the treatment of recurrent pregnancy loss with a prospective randomized controlled trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 22, 2018
• Est. primary completion date: June 10, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Woman who had 2 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 experienced severe allergies, trauma history and/or operation history within 3 months.

2. with a history of mental illness and/or family history of mental illness limb disabled.

3. taking medicine within one month.

4. suffering major events or having mood swings.

5. having internal and surgical disease(after having variety of physical examination such as electrocardiogram/hepatic and renal function/blood routine and urine routine)

6. chromosome aberrations in anyone of the couple.

7. patients who have drugs contraindications

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Fetal Death
• Recurrent Pregnancy Loss

Intervention

Drug:
• Aspirin

• Heparin

• Prednisone

• Immunoglobulin

• Dydrogesterone

Locations

Country	Name	City	State
China	Shanghai first Maternity and Infant health hospital, Tong Ji University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai First Maternity and Infant Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	live birth	live birth means success pregnancy(more than gestational age of 20 weeks)	through study completion, an average of 3 year
Secondary	D-dimer		through study completion, an average of 3 year
Secondary	Uterine artery blood flow		through study completion, an average of 3 year
Secondary	human chorionic gonadotropin		through study completion, an average of 3 year