Contraception and pregnancy in microbicide trials
Best Practice & Research Clinical Obstetrics & Gynaecology, 07/03/2012
Sibeko S et al. – High pregnancy rates in such trials may compromise statistical integrity, as women will be withdrawn from the study drug for the duration of the pregnancy. It is therefore imperative for microbicide trials to implement effective contraceptive and pregnancy management programmes that maintain low pregnancy rates and the safety of unborn babies while not compromising the conduct and statistical integrity of the trial.