Document Detail

Oral dydrogesterone treatment during the first trimester of pregnancy: the prevention of miscarriage study (PROMIS). A double-blind, prospectively randomized, placebo-controlled, parallel group trial.
MedLine Citation:
PMID:  16318978     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: A planned study to test the hypothesis that dydrogesterone given during the first trimester of pregnancy can positively influence the immune system of women suffering from recurrent miscarriages and thereby lead to successful pregnancies. The primary objective is to show whether the administration of dydrogesterone during the first trimester of pregnancy increases the release of progesterone-induced blocking factor (PIBF) and causes a shift from Th-1 cytokines to Th-2 cytokines. Further objectives are an analysis of pregnancy outcome and to investigate the tolerability and safety of dydrogesterone use during pregnancy. METHODS: A prospectively randomized, placebo-controlled study of 20 mg dydrogesterone per day during the first trimester of pregnancy in women aged between 18 and 38 and with a history of idiopathic recurrent miscarriage. Start of treatment will be after ovulation. The study will be conducted in a two-stage adaptive design, starting with a sample size of 20 patients per treatment group. The concentrations of Th-1 and Th-2 cytokines in the serum and PIBF in the urine will be measured. Efficacy will be measured primarily by the ratio IFNgamma/IL-10. CONCLUSION: The results of this study will contribute to the discussion of a current concept of immunomodulation in pregnancy and potentially provide a treatment option for patients suffering from recurrent miscarriage.
Katharina Walch; Lukas Hefler; Friedrich Nagele
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians     Volume:  18     ISSN:  1476-7058     ISO Abbreviation:  J. Matern. Fetal. Neonatal. Med.     Publication Date:  2005 Oct 
Date Detail:
Created Date:  2005-12-01     Completed Date:  2006-04-11     Revised Date:  2008-11-21    
Medline Journal Info:
Nlm Unique ID:  101136916     Medline TA:  J Matern Fetal Neonatal Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  265-9     Citation Subset:  IM    
Department of Obstetrics and Gynecology, Division of Gynecological Endocrinology and Reproductive Medicine, University of Vienna School of Medicine, Vienna, Austria.
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MeSH Terms
Abortion, Habitual / immunology*,  prevention & control*
Administration, Oral
Double-Blind Method
Dydrogesterone / pharmacology,  therapeutic use*
Pregnancy Proteins / urine
Pregnancy Trimester, First
Prospective Studies
Suppressor Factors, Immunologic
Th1 Cells / metabolism
Th2 Cells / metabolism
Reg. No./Substance:
0/PIBF1 protein, human; 0/Pregnancy Proteins; 0/Suppressor Factors, Immunologic; 152-62-5/Dydrogesterone

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