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Oral dydrogesterone treatment during early pregnancy to prevent recurrent pregnancy loss and its role in modulation of cytokine production: a double-blind, randomized, parallel, placebo-controlled trial.

AbstractOBJECTIVE:
To study the impact of administration of dydrogesterone in early pregnancy on pregnancy outcome and its correlation with Th1 and Th2 cytokine levels.
DESIGN:
Double-blind, randomized, placebo-controlled study.
SETTING:
A medical college and its associated hospital.
PATIENT(S):
Women with either: [1] a history of idiopathic recurrent pregnancy loss (RPL), in either a dydrogesterone group or a placebo group, or [2] no history of miscarriage.
INTERVENTION(S):
Dydrogesterone 20 mg/day from confirmation of pregnancy to 20 weeks of gestation.
MAIN OUTCOME MEASURE(S):
Occurrence of another pregnancy loss and concentrations of T-helper (Th)1 (interferon-γ and tumor necrosis factor-α) and Th2 (interleukin (IL)-4 and IL-10) cytokines in serum at recruitment (4-8 weeks of gestation) and at abortion or 20 weeks of gestation, using commercially available ELISA kits.
RESULT(S):
Occurrence of another abortion after 3 consecutive abortions was significantly higher (29 of 173; 16.76%) in women with RPL compared with healthy pregnant controls (6 of 174; 3.45%). Risk of occurrence of miscarriage after 3 abortions was 2.4 times higher in the placebo group vs. the treatment group (risk ratio=2.4, 95% CI=1.3-5.9). Mean gestational age at delivery (excluding those aborted before 20 weeks of gestation) increased significantly in the dydrogesterone group (38.01±1.96 weeks) compared with the placebo group (37.23±2.41 weeks). Baby weight was significantly lower in the placebo group (2421.4±321.6 g) compared with the healthy pregnant controls (2545.3±554.3 g). At recruitment, serum IL-4 and tumor necrosis factor-α levels were significantly lower in the RPL group compared with the healthy pregnant controls. However, serum interferon-γ level was significantly higher in the RPL group (8.87±0.72 pg/mL) compared with the healthy pregnant controls (8.08±1.27 pg/mL).
CONCLUSION(S):
The present study supports the use of dydrogesterone in women with recurrent abortions to improve pregnancy outcome, such as a reduction in abortions and improved gestational age and baby weight at delivery. However, these outcomes were not modulated by Th1 and Th2 cytokine production.
CLINICAL TRIAL REGISTRATION NUMBER:
CTRI/2010/091/000373.
AuthorsAshok Kumar, Nargis Begum, Sudha Prasad, Sarita Aggarwal, Shashi Sharma
JournalFertility and sterility (Fertil Steril) Vol. 102 Issue 5 Pg. 1357-1363.e3 (Nov 2014) ISSN: 1556-5653 [Electronic] United States
PMID25241364 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
CopyrightCopyright © 2014 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.
Chemical References
  • Cytokines
  • Progestins
  • Dydrogesterone
Topics
  • Abortion, Habitual (epidemiology, immunology, prevention & control)
  • Administration, Oral
  • Adult
  • Cytokines (immunology)
  • Double-Blind Method
  • Dydrogesterone (administration & dosage)
  • Female
  • Humans
  • India (epidemiology)
  • Placebo Effect
  • Pregnancy
  • Prevalence
  • Progestins (administration & dosage)
  • Risk Factors
  • Th1-Th2 Balance
  • Treatment Outcome

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