Thorp, John M., Jr. (2017). BJOG Editor's Choice: Outcome Standardisation – Next Rung in the Ladder for Perinatal Epidemiology. BJOG: An International Journal of Obstetrics & Gynaecology, 124(12)
Clinical trials in obstetrics are even more difficult and costly than trials in other branches of medicine. Part of this is due to the fact that most pregnancies have good outcomes whatever care is given. Another portion can be attributed to the resiliency of the newborn so that even after a catastrophic event and short-term morbidity, many babies make full recoveries. Perinatal clinical trialists know these facts and either have to rely on surrogate outcomes that are intermediate, e.g. cord gasses at birth rather that IQ at age 5 years, or enrol a very large number of women to show meaningful differences. I am in the midst of a large trial to look at immune globulin treatment in primary cytomegalovirus (CMV) infections where the 1/1000 prevalence has forced us to screen 160 000 women to enroll around 100 people into the clinical trial. Many babies exposed to CMV in utero experience no damage, so we will have even fewer ‘hard’ outcomes to assess.
BJOG: An International Journal of Obstetrics & Gynaecology
Thorp, John M., Jr.