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Completed

NCT Number: NCT00193674

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

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).

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Key information

Conditions

Recurrent Miscarriage Abortion, Habitual Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Site Reference ID/Investigator# 61182, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dydrogesterone

Drug

20 mg/day, oral

Placebo

Drug

Placebo

Primary outcomes

  1. Cytokine ratio IFN/IL-10

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

Secondary outcomes

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

    Time frame: First trimester of pregnancy

Sponsors and collaborators

Lead sponsor

Abbott Products

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Sep 19, 2005
Registry last updated
Aug 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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