Habitual Abortion Study: Oral Dydrogesterone Treatment During Pregnancy in Women With Recurrent Miscarriage

Phase 3

Completed

• Conditions: Recurrent Miscarriage
• Interventions: Drug: Placebo; Drug: Dydrogesterone

• Registration Number: NCT00193674
• Lead Sponsor: Abbott Products

Brief Summary

The purpose of this clinical study is to demonstrate the shift from inflammatory cytokines to non-inflammatory cytokines in women suffering from habitual abortion treated with dydrogesterone (Duphaston).

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2005-09-11
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-19
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-25
• Last Update Posted: 2011-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 71

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	Dydrogesterone	-

Primary Outcome Measures

Name	Time	Method
Cytokine ratio IFN/IL-10	14 weeks treatment after diagnosed pregnancy (week of gestation 4 to 18)

Secondary Outcome Measures

Name	Time	Method
Exploratory analysis of pregnancy outcome by monitoring biochemical and clinical pregnancy parameters, weekly evaluation of serum progesterone	First trimester of pregnancy

Trial Locations

Locations (3)

Site Reference ID/Investigator# 61182; 🇦🇹 Vienna, Austria

Site Reference ID/Investigator# 61183; 🇵🇱 Poznan, Poland

Site Reference ID/Investigator# 61184; 🇵🇱 Szczecin, Poland