This prospective cross-sectional study was conducted over one year, from Dec 2020 to Dec 2021. Given the low prevalence of protein C and S deficiency worldwide, which is estimated to be around 3 cases per thousand individuals, the presumed prevalence value of 0.003 was used in the PASS software while applying the Exact Clopper Pearson method. The estimated sample size for the prospective study group was determined to be n=38. This sample size provides a two-sided 95% confidence interval with a width of 0.098.
Using a mathematical relationship between the F distribution and the cumulative binomial distribution, the lower and upper confidence limits of a 100 (1-a)% exact confidence interval for the true proportion p are given by:
In the present study, 80 pregnant women were recruited and divided into two groups for analysis. Group A, also known as the case group, consisted of 40 women who experienced three or more miscarriages in the first or second trimester of pregnancy. Group B, also known as the control group, consisted of 40 healthy pregnant women in their third trimester.
We collected a detailed history from each participant, including demographic profile and comprehensive obstetric and drug history. Additionally, we collected data on their current symptoms, including leg pain, chest discomfort with breathlessness, weakness on one side of the body, and history of deep vein thrombosis (DVT), stroke, low birth weight (LBW), and intrauterine growth retardation (IUGR). Following this, a detailed general and local examination was performed by the concerned gynecologist. This examination included checking vital signs, body mass index (BMI) and performing an abdominal and pelvic examination. Finally, a series of routine laboratory tests were recommended (complete blood count, urine analysis, blood glucose, thyroid profile, Protein C and S), and an ultrasound was performed. Hypertensive patients received multivitamins, progesterone support, and amlodipine.
In addition to the laboratory tests, we also analyzed the antenatal ultrasound for each case. Most of the cases showed normal results on ultrasound, except for a few cases with low levels of protein C and S, which showed signs of IUGR on ultrasound. To further investigate these cases, we performed a Doppler flow study to evaluate any signs of reduced umbilical blood flow, which could indicate the presence of thrombosis. Patients were followed up with laboratory results, and those with low protein C and S levels were prescribed low molecular weight heparin (LMWH) by the gynecologist as an additional treatment to prevent thrombotic events.