Obstetric Pharmacokinetic Dosing Studies are Urgently Needed

Area of Science:

• Pharmacology
• Obstetrics
• Clinical Trials

Background:

• Medication use during pregnancy is common and increasing.
• Physiological changes in pregnancy alter drug pharmacokinetics, potentially requiring dose adjustments.
• Limited pharmacokinetic data exists for pregnant populations.

Purpose of the Study:

• To review the landscape of pharmacokinetic studies in pregnant women.
• To identify gaps in knowledge regarding medication dosing during pregnancy.
• To highlight the need for increased research in obstetric pharmacokinetics.

Main Methods:

• Conducted a PubMed search for pharmacokinetic clinical trials in pregnancy.
• Analyzed studies published from the late 1960s to August 2013.
• Examined recent studies (since 2008) for indications and funding sources.

Main Results:

• Only 1.29% of all pharmacokinetic studies focused on pregnancy.
• Recent studies covered labor, infectious diseases, and ante-partum indications.
• Most studies were government-funded; pharmaceutical industry funding was minimal (<10%).

Conclusions:

• Significant gaps in pharmacokinetic information for pregnant women persist.
• Lack of data increases risks of suboptimal efficacy and toxicity for mother and fetus.
• Urgent need for increased support and performance of obstetric dosing and pharmacokinetic studies.