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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00193674
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : August 26, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
Recurrent Miscarriage Drug: Dydrogesterone Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : September 2003
Primary Completion Date : July 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Miscarriage
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: Dydrogesterone
20 mg/day, oral
Placebo Comparator: 2 Drug: Placebo
Placebo


Outcome Measures

Primary Outcome Measures :
  1. Cytokine ratio IFN/IL-10 [ Time Frame: 14 weeks treatment after diagnosed pregnancy (week of gestation 4 to 18) ]

Secondary Outcome Measures :
  1. Exploratory analysis of pregnancy outcome by monitoring biochemical and clinical pregnancy parameters, weekly evaluation of serum progesterone [ Time Frame: First trimester of pregnancy ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00193674


Locations
Austria
Site Reference ID/Investigator# 61182
Vienna, Austria, 1090
Poland
Site Reference ID/Investigator# 61183
Poznan, Poland, 60-535
Site Reference ID/Investigator# 61184
Szczecin, Poland, 72-010
Sponsors and Collaborators
Abbott Products
Investigators
Study Director: Guenter Krause, MD Abbott Products
More Information

Responsible Party: Abbott Products
ClinicalTrials.gov Identifier: NCT00193674     History of Changes
Other Study ID Numbers: S102.3.116
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: August 26, 2011
Last Verified: August 2011

Keywords provided by Abbott ( Abbott Products ):
Pregnancy
Immunology
Unexplained recurrent miscarriage

Additional relevant MeSH terms:
Abortion, Spontaneous
Abortion, Habitual
Pregnancy Complications
Dydrogesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs