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Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Lack of risk of adverse birth outcomes after deworming in pregnant women.
Pediatric Infectious Disease Journal 2006 September
BACKGROUND: Pregnant women who live in hookworm-endemic areas may benefit from deworming during their pregnancy. The benefit derives from reducing anemia, primarily iron-deficiency anemia caused by hookworm infection-attributable blood loss. Where the prevalence of hookworm is more than 20% to 30%, the World Health Organization recommends that pregnant women receive anthelminthic treatment (mebendazole, albendazole, levamisole or pyrantel) after their first trimester. The objective of this study is to report, describe and compare the occurrence of adverse birth outcomes in a large randomized, controlled trial of antenatal mebendazole (500 mg single dose) plus iron supplements versus placebo plus iron supplements conducted between April 2003 and June 2004 in the Amazon region of Peru.
METHODS: Physician-recorded data on adverse birth outcomes occurring during the trial (N = 1042) were obtained. Proportions were compared using chi analysis.
RESULTS: No statistically significant difference (P = 0.664) was found between the mebendazole group and the placebo group in terms of numbers of miscarriages, malformations, stillbirths, early neonatal deaths and premature babies (28 versus 31, respectively).
CONCLUSIONS: The evidence provided by this large randomized, controlled trial of mebendazole administered during pregnancy indicates that deworming with mebendazole can be safely included in antenatal care programs in hookworm-endemic areas.
METHODS: Physician-recorded data on adverse birth outcomes occurring during the trial (N = 1042) were obtained. Proportions were compared using chi analysis.
RESULTS: No statistically significant difference (P = 0.664) was found between the mebendazole group and the placebo group in terms of numbers of miscarriages, malformations, stillbirths, early neonatal deaths and premature babies (28 versus 31, respectively).
CONCLUSIONS: The evidence provided by this large randomized, controlled trial of mebendazole administered during pregnancy indicates that deworming with mebendazole can be safely included in antenatal care programs in hookworm-endemic areas.
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