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The fetal safety of clomiphene citrate: a population-based retrospective cohort study.
Weller, A; Daniel, S; Koren, G; Lunenfeld, E; Levy, A.
Afiliação
  • Weller A; Department of Public Health, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
  • Daniel S; BeMORE collaboration (Ben-Gurion Motherisk Obstetric Registry of Exposure collaboration), Beer-Sheva, Israel.
  • Koren G; Department of Public Health, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
  • Lunenfeld E; BeMORE collaboration (Ben-Gurion Motherisk Obstetric Registry of Exposure collaboration), Beer-Sheva, Israel.
  • Levy A; Department of Pediatrics, Soroka Medical Center, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
BJOG ; 124(11): 1664-1670, 2017 Oct.
Article em En | MEDLINE | ID: mdl-28334503
ABSTRACT

OBJECTIVE:

To evaluate whether exposure to clomiphene citrate (CC) for ovulation induction is associated with major malformations overall or with specific fetal anomalies.

DESIGN:

We conducted a population-based retrospective cohort study. Exposure was defined as CC dispension from 2 months before conception through the first month of pregnancy. SETTINGS Four databases were combined medication, birth, hospitalization, and terminations of pregnancy. POPULATION The study included all women in southern Israel who gave birth or underwent termination of pregnancy at Soroka Medical Center, from 1998 to 2009.

METHODS:

The rates of major malformations overall and six different subcategories of anomalies were evaluated. The crude odds ratio (OR) was calculated with a 95% confidence interval (95% CI). Subsequently the adjusted odds ratio (aOR) was calculated using multiple logistic regression models controlling for maternal age, pre-pregnancy diabetes, parity, ethnicity, the calendar year in which the birth/termination of pregnancy took place, smoking, and the use of gonadotropins and progesterone. MAIN OUTCOME

MEASURES:

Major malformations overall and specific fetal malformations by organ systems.

RESULTS:

Of 114 961 pregnant women, 1872 were exposed to CC. No association was detected between exposure to CC and rates of major malformations overall (aOR 1.08, 95% CI 0.88-1.32) or rates of subcategories of malformations. Exposure was not associated with anencephaly (aOR 2.27, 95% CI 0.44-11.71) or oesophageal atresia (aOR 3.681, 95% CI, 0.65-20.76).

CONCLUSIONS:

In this large population-based retrospective cohort study, exposure to CC was not associated with an increased risk of either rates of major malformations overall or rates of specific malformations. TWEETABLE ABSTRACT An observational study no increased risk for fetal malformations following exposure to clomiphene citrate.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Anormalidades Congênitas / Anormalidades Induzidas por Medicamentos / Clomifeno / Fármacos para a Fertilidade Feminina / Infertilidade Feminina Tipo de estudo: Etiology_studies / Incidence_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Adolescent / Adult / Female / Humans / Newborn / Pregnancy País/Região como assunto: Asia Idioma: En Revista: BJOG Assunto da revista: GINECOLOGIA / OBSTETRICIA Ano de publicação: 2017 Tipo de documento: Article País de afiliação: Israel

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Anormalidades Congênitas / Anormalidades Induzidas por Medicamentos / Clomifeno / Fármacos para a Fertilidade Feminina / Infertilidade Feminina Tipo de estudo: Etiology_studies / Incidence_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Adolescent / Adult / Female / Humans / Newborn / Pregnancy País/Região como assunto: Asia Idioma: En Revista: BJOG Assunto da revista: GINECOLOGIA / OBSTETRICIA Ano de publicação: 2017 Tipo de documento: Article País de afiliação: Israel