ABSTRACT
Pregnant and lactating women are two special populations that present unique challenges for conducting research. Many women of reproductive age group (15-5 year) may have chronic medical problems and use a variety of pharmaceutical products (e.g., drugs, vaccines, and other biologic therapies). In the U.S., 60 million women are of reproductive age (15-44) [1], and there are about four million births per year [2]. The magnitude of major chronic conditions in women less than 45 years is significant. In this population, asthma affects 6,099,000 women; epilepsy affects 466,000; and hypertension affects 2,700,000 [2]. The prevalence of these conditions among pregnant women are 7% for asthma, 0.6-1.0% for epilepsy, and 6% for hypertension [2]. Thus, many women enter pregnancy with medical conditions that require ongoing or episodic treatment. New medical problems may develop or old ones may be exacerbated by pregnancy (e.g., infections, migraine headaches, depression). Lactating women, as well, may require medication for chronic or acute conditions.
