The 1953 Clinical Trial of Diethylstilbestrol During Pregnancy: Could It Have Stopped DES Use?

Abstract

The legacy of diethylstilbestrol (DES) lives on in children of an estimated 2-3 million women exposed to it during pregnancy.

  • Do we know that children of the DES children are not at an increased risk of conditions transmitted from the DES grandmother?
  • Could the tragic consequence of DES have been prevented with the Dieckmann et al clinical trial? 

SUSPENDED JUDGMENT, The 1953 Clinical Trial of Diethylstilbestrol During Pregnancy: Could It Have Stopped DES Use?, Heinz W. Berendes, MD, MHS, and Young J. Lee, PhD, Division of Epidemiology, Statistics and Prevention Research, National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland, sciencedirect, 1993.

The answer to this latter question is no. DES was introduced and promoted long before the trial. However, had the Dieckmann DES clinial trial preceded the widespread use of DES, then the answer could have been yes. More realistically, the answer is somewhere in the middle. We believe that it is a good question to raise, but an impossible one to answer.

Dieckmann et al conducted a clinical trial to determine the value of DES in their obstetrical practice between September 1950 and November 1952. Women were eligible to participate if they registered in prenatal clinics affiliated with the Department of Obstetrics of the University of Chicago and were 6-20 weeks pregnant. Women with such complications as chronic hypertensive vascular disease, diabetes mellitus, or repeat abortions were included. Participants were assigned consecutively with every other patient serving as a control. Treatment was continued from enrollment to 35 weeks gestation. Clinicians, patients, and statisticians were blinded regarding the treatment allocation of patients. Patients kept dally records of tablets consumed that were checked against the box of tablets received at each prenatal visit and at 35 weeks gestation when treatment was terminated. The treatment and the placebo tablets included a dye to check objectively on patients compliance, and patients were asked to provide urine specimens at each visit. No information is available”

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