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

Phase 3CompletedNCT00193674

Abbott Products71 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Recurrent Miscarriage

Interventions

DydrogesteroneDRUG

20 mg/day, oral

PlaceboDRUG

Placebo

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 38 Years

Medical Language ↔ Plain English

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

Locations (3)

Site Reference ID/Investigator# 61182

Vienna, Austria

Site Reference ID/Investigator# 61183

Poznan, Poland

Site Reference ID/Investigator# 61184

Szczecin, Poland

Outcomes

Primary Outcomes

Cytokine ratio IFN/IL-10

Time frame: 14 weeks treatment after diagnosed pregnancy (week of gestation 4 to 18)

Secondary Outcomes

Exploratory analysis of pregnancy outcome by monitoring biochemical and clinical pregnancy parameters, weekly evaluation of serum progesterone

Time frame: First trimester of pregnancy

Data from ClinicalTrials.gov

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