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

Recurrent Miscarriage Clinical Trial

Official title:

Oral Dydrogesterone Treatment During the First Trimester of Pregnancy in Women With Recurrent Miscarriage: A Double-Blind, Prospectively Randomized, Placebo-Controlled, Parallel Group Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193674
• Other study ID #: S102.3.116
• Status: Completed
• Phase: Phase 3
• First received: September 11, 2005
• Last updated: August 25, 2011
• Start date: September 2003
• Est. completion date: July 2009

Study information

• Verified date: August 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and WomenPoland: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

Inclusion Criteria

• Women with a history of idiopathic recurrent miscarriage, based on a documented history of at least three spontaneous consecutive miscarriages before 20 weeks gestation with the same partner Exclusion Criteria

• Any verifiable cause of the recurrent miscarriages apart from luteal phase defect (e.g. systemic lupus erythematosus [SLE], infections with chlamydia or mycoplasma)

• Any gynecological neoplasias or anatomical abnormalities that oppose pregnancy

• Concurrent infertility treatment/superovulation protocol

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Recurrent Miscarriage

Intervention

Drug:
• Dydrogesterone
20 mg/day, oral
• Placebo
Placebo

Locations

Country	Name	City	State
Austria	Site Reference ID/Investigator# 61182	Vienna
Poland	Site Reference ID/Investigator# 61183	Poznan
Poland	Site Reference ID/Investigator# 61184	Szczecin

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Products

Countries where clinical trial is conducted

Austria,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cytokine ratio IFN/IL-10		14 weeks treatment after diagnosed pregnancy (week of gestation 4 to 18)	No
Secondary	Exploratory analysis of pregnancy outcome by monitoring biochemical and clinical pregnancy parameters, weekly evaluation of serum progesterone		First trimester of pregnancy	No