The Novel Immunomodulatory and Anticoagulant Therapies for Recurrent Pregnancy Loss

Phase 4

• Conditions: Recurrent Pregnancy Loss
• Interventions: Drug: Aspirin; Drug: Dydrogesterone; Drug: Heparin; Drug: Prednisone; Drug: Immunoglobulin

• Registration Number: NCT02990403
• Lead Sponsor: Shanghai First Maternity and Infant Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Status Verified: 2016-12
• Study First Submitted: 2016-12-07
• Study First Submitted QC: 2016-12-08
• Study First Posted: 2016-12-13
• Last Update Submitted: 2017-03-06
• Last Update Posted: 2017-03-08
• Primary Completion: 2017-06-10
• Study Completion: 2018-12-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aspirin+LMWH group	Aspirin	aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100U,hypodermic injection，qd
aspirin+LMWH+IVIG+prednisone group	Prednisone	aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + immunoglobulin 300mg/kg（with 100ml normal saline）,intravenous injection,once every two weeks + prednisone,5-10mg/day,po,qd
aspirin+LMWH+IVIG+prednisone group	Immunoglobulin	aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + immunoglobulin 300mg/kg（with 100ml normal saline）,intravenous injection,once every two weeks + prednisone,5-10mg/day,po,qd
dydrogesterone group	Dydrogesterone	dydrogesterone 20-30mg/day, po, tid
aspirin+LMWH group	Heparin	aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100U,hypodermic injection，qd
aspirin+LMWH+immunoglobulin group	Aspirin	aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + immunoglobulin 300mg/kg（with 100ml normal saline）,intravenous injection,once every two weeks
aspirin+LMWH+immunoglobulin group	Heparin	aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + immunoglobulin 300mg/kg（with 100ml normal saline）,intravenous injection,once every two weeks
aspirin+LMWH+immunoglobulin group	Immunoglobulin	aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + immunoglobulin 300mg/kg（with 100ml normal saline）,intravenous injection,once every two weeks
aspirin+LMWH+prednisone group	Aspirin	aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + prednisone,5-10mg/day,po,qd
aspirin+LMWH+IVIG+prednisone group	Heparin	aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + immunoglobulin 300mg/kg（with 100ml normal saline）,intravenous injection,once every two weeks + prednisone,5-10mg/day,po,qd
aspirin+LMWH+prednisone group	Heparin	aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + prednisone,5-10mg/day,po,qd
aspirin+LMWH+IVIG+prednisone group	Aspirin	aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + immunoglobulin 300mg/kg（with 100ml normal saline）,intravenous injection,once every two weeks + prednisone,5-10mg/day,po,qd
aspirin+LMWH+prednisone group	Prednisone	aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + prednisone,5-10mg/day,po,qd

Primary Outcome Measures

Name	Time	Method
live birth	through study completion, an average of 3 year	live birth means success pregnancy（more than gestational age of 20 weeks）

Secondary Outcome Measures

Name	Time	Method
D-dimer	through study completion, an average of 3 year
Uterine artery blood flow	through study completion, an average of 3 year
human chorionic gonadotropin	through study completion, an average of 3 year

Trial Locations

Locations (1)

Shanghai first Maternity and Infant health hospital, Tong Ji University; 🇨🇳 Shanghai, China