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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott ( Abbott Products )
ClinicalTrials.gov Identifier:
NCT00193674
First received: September 11, 2005
Last updated: August 25, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Recurrent Miscarriage
Drug: Dydrogesterone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Cytokine ratio IFN/IL-10 [ Time Frame: 14 weeks treatment after diagnosed pregnancy (week of gestation 4 to 18) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Exploratory analysis of pregnancy outcome by monitoring biochemical and clinical pregnancy parameters, weekly evaluation of serum progesterone [ Time Frame: First trimester of pregnancy ] [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: September 2003
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Dydrogesterone
20 mg/day, oral
Placebo Comparator: 2 Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Abbott ( Abbott Products )
ClinicalTrials.gov Identifier: NCT00193674     History of Changes
Other Study ID Numbers: S102.3.116
Study First Received: September 11, 2005
Last Updated: August 25, 2011
Health Authority: Austria: Federal Ministry for Health and Women
Poland: Ministry of Health

Keywords provided by Abbott:
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014