Abstract | OBJECTIVE: 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.
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Authors | Ashok Kumar, Nargis Begum, Sudha Prasad, Sarita Aggarwal, Shashi Sharma |
Journal | Fertility and sterility
(Fertil Steril)
Vol. 102
Issue 5
Pg. 1357-1363.e3
(Nov 2014)
ISSN: 1556-5653 [Electronic] United States |
PMID | 25241364
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2014 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Cytokines
- Progestins
- Dydrogesterone
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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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