Potential use of single measurement of serum progesterone in detecting early pregnancy failure.

Early pregnancy failure is a common pregnancy complication. In clinical practice, the time delay to distinguish viable from nonviable pregnancy is often distressing to patients and doctors. A highly sensitive and specific biomarker that accurately discriminates between viable and nonviable pregnancy would be useful for early intervention. Progesterone has been shown as a biomarker of early pregnancy failure. However the usefulness is still questionable due to the different cutoff values used. A study was conducted to determine the role of progesterone as a marker of early pregnancy failure and to establish the cut-off value in discriminating between viable and nonviable pregnancy. The study was carried out in the Obstetric and Gynecology Patient Admission Centre (OBPAC), Universiti Kebangsaan Malaysia Medical Centre (UKMMC) for a period of twelve months. Ninety-five pregnant women of 13 weeks or less period of amenorrhoea (POA) were recruited. Fourteen normal pregnant women were controls. The patients with early pregnancy failure were classified according to types of abortion. Single measurement of serum progesterone was carried out during admission. The outcome of pregnancy was followed up until 22 weeks of POA to ascertain viability of the fetus. Median progesterone levels were significantly lower in women with nonviable pregnancies compared with viable pregnancy [10.7ng/ml (0.60-49.80) vs. 45.9ng/ml (15.40-127.20) respectively, p<0.001]. Progesterone levels were also significantly lower in threatened abortion patients with outcomes of nonviable pregnancy compared with pregnancies that progressed on to the viability period [23.3 +/- 12.0 vs. 89.7 +/- 33.2 respectively, p<0.001]. At cut-off value of 32.7ng/ ml, progesterone had 90% sensitivity with 75% negative predictive value and 92% specificity with 97% positive predictive value. The area under curve for progesterone was 0.95 (95% Confidence Interval, 0.903-0.990). In conclusion, these findings indicate that serum progesterone can be used as a marker for early pregnancy failure.