Drugs use in pregnancy should always question two important queries and maintain a fine balance of them; no harm should be posed to the baby due to the drug, and no harm must come to the mother or baby because of inadequate treatment (1). Medication use during pregnancy has been an issue of serious concern and needs monitoring since historical milestone of thalidomide disaster during the 1960s (2). The physiologic, pharmacokinetic and pharmacodynamic changes occur during pregnancy requires special therapeutic consideration in pregnant and lactating women. Not only the changes have occurred, but also these physiologic changes are not fixed throughout pregnancy but rather reflect a continuum of change as pregnancy progresses. Moreover, pregnant women have been often excluded from clinical trials and extrapolation of pharmacokinetics data from studies performed in non-pregnant adults or evidences generated from animal studies are not often suitable (3). Therefore, pregnancy management using medications has been challenging to both health care providers and pregnant women, given the fear of teratogenicity effects and the potential for fetal harms.
A large number of studies have reported that the utilization of a large number of drugs during pregnancy (4-8). Substantial number of drugs was also used from Food and Drug administration (FDA) pregnancy risk category D and X (9). Hence this study was carried out to evaluate the pattern of drug use and potential teratogenicity risk to fetus in women attending Maternal and Child Health (MCH) clinic of Kemisse General Hospital (KGH) in eastern Amhara, Ethiopia.
Study area, design and period
The study was conducted at Kemisse General Hospital (KGH), located in Northeast Ethiopia, Oromia Special Zone, Amhara National Regional State, 331 km away from north of Addis Ababa. The hospital is the only general hospital in the zone and currently serving about 1.2 million catchment population from all population in the zone and nearby districts. An institution based cross sectional study was conducted from March 1 to April 20, 2019 by reviewing a one year medical records (from January 1, 2010 to December 31, 2011) of pregnant women attending maternal and child health (MCH) clinic of the hospital.
Study population
All medical records of pregnant women who attended MCH clinic of KGH from Jan 1, 2010 to Dec 30, 2011 were taken as a study population. Women came for Antenatal Care (ANC) and enrolled in routine ANC program from Jan 1, 2010 - Dec 31, 2011.
Sample size determination and sampling technique
By using single population proportion formula, the sample size was determined as follows:
n= z2 p (1-p) = (1.96)2*(0.875) (1- 0.875) = 467
d2 (0.03)2
, where n = desired sample size for population>10,000, Z= confidence level at 95% (1.96), P=proportion of drug use during pregnancy, 87.5% (9), d= degree of accuracy desired (marginal error) is 0.03. Since the total number of pregnant women who attended MCH of KGH during the review period was 600 (<10,000), correction formula was used to determine final sample size
nf = ni = 467/(1+467/600) = 263
1+ni
N
Where, nf = final sample size, ni = initial sample size, and N= study population. Systematic random sampling was employed to select the study units.
Data collection processes and data quality control
The data abstraction format used contained information regarding to obstetric history (age, trimesters of pregnancy, gravidity, number of visits), clinical and drug related data (common maternal disorders, common classes of drugs in each trimesters, and prescribed medications) and FDA pregnancy risk category. Pretest was done at Bati primary hospital located in the nearby town. Important corrections and data cleaning on daily basis were made.
Data processing and analysis
The data were coded, entered and analyzed by using Statistical Package for Social Sciences (SPSS) version 23 (IBM statistics, Armonk, NY, USA). Data were presented in tables and figure.