Study setting, design and Population
A multi-centered hospital based case control study was conducted among pregnant women attending referral hospitals in Southwestern parts of Oromia regional state, Southwest Ethiopia from June 1 to September 30, 2019. All hospitals are teaching and referral hospital that gave general and specialized clinical services including ANC, family planning, delivery service & treatment obstetric complications are some of the services provided in gynecologic and obstetric ward. These services have been delivered by senior midwives, gynecologists/obstetricians. All pregnant women attending gynecology and obstetrics department of JMC (Jimma Medical Center), WURH ( Wellega University Referral Hospital), NRH ( Nekemte Referral Hospital), AURH (Ambo Referral Hospital) and MKRH (Mettu Karl Referral Hospital) during the four-month study period were source population.
Study population: for cases all pregnant women who had been confirmed by ultrasound and HCG to have EP in the inpatient department of gynecology and obstetrics of each hospital were recruited. For controls: Controls were sampled pregnant women confirmed by ultrasound and HCG to have intra uterine pregnancy at the prenatal clinic in department of gynecology and obstetrics of each hospital.
Eligibility criteria
Inclusion criteria for cases: admitted women who had been confirmed by ultrasound and HCG to have EP in the inpatient department of gynecology and obstetrics of each hospital. For controls: Controls were sampled pregnant women confirmed by ultrasound and HCG to have intra uterine pregnancy at the prenatal clinic in department of gynecology and obstetrics of each hospital.
Exclusion criteria for both cases and controls: Women with serious medical conditions and couldn’t give consent were excluded from the study.
Case Definition: Case pregnant women diagnosed by hCG and ultrasound to have ectopic pregnancy confirmed by Obstetrician/gynecologist(12).
Control: Pregnant women diagnosed by hCG and ultrasound to have intrauterine pregnancy confirmed by Obstetrician/gynecologist(12)
Sample size and sampling procedure
The required sample size was determined by using Epi-info version 7 statistical software for unmatched case-control study design. Results from similar studies were used to approximate the sample size in different potential risk factors of ectopic pregnancy. In a study report from India prior tubal surgery was a significant risk factor for ectopic pregnancy (13). A case control study in western Ethiopia at Nekemte hospital marital status was a significant risk factor for ectopic pregnancy (14). Similarly, case control study done in Turkey Ankara previous history of ectopic pregnancy was a significant risk factor for ectopic pregnancy (15). Using these reports as starting point, similar assumptions P1: proportion among cases and p2: proportion of among controls AOR: Adjusted odds ratio at 95% (Zα/2 = 1.96) level of confidence, Power of study=80% Ratio of cases to controls = 1:2
Table 1: Epi Info sample size calculation by using different exposure variables.
Exposure variables
|
Proportion
among cases
|
Proportion on among
controls
|
AOR
|
Sample size
|
Final
Sample
Adding 10% nonresponse
|
Cases
|
Controls
|
|
Pervious History of ectopic pregnancy
|
9.7
|
1.3
|
13.1
|
53
|
106
|
177
|
|
Single marital status
|
25
|
3
|
10.8
|
32
|
64
|
105
|
|
Pervious tubal surgery
|
44
|
3
|
14
|
25
|
50
|
84
|
|
From the above three significant risk factors of ectopic pregnancy, previous history of ectopic pregnancy gives the large sample size so which is 59 cases and 118 controls. With total of 177 study participants. In the selected five referral hospitals the number of pregnant women registered during the 2018 G.C HMIS report over four months at JMC, WURH, NRH, AURH and MKRH were 1707, 1085, 679, 1489 and 1219 respectively
The calculated sample size was proportionally allocated based on the estimated number of pregnant women in selected referral hospitals. Therefore, (16 cases and 32 controls) from JMC, (10 cases and 20 controls) from WURH, (7 cases and 14 controls) from NRH, (14 cases and 28 controls) from AURH and (12 cases and 28 controls) from MKRH. Then, the study participant was selected using consecutive sampling technique.
Data collection tools and procedures
The data were collected by face to face interview using semi structured questionnaire addressing socio-demographic and obstetric, gynecologic, behavioral, surgical history and contraceptive characteristics of study participants which was developed after reviewing different literatures. Fifteen trained data collectors and five supervisors were involved in the process.
Data quality Control
The urine sample collection was done through standardized, and sterile technique by professional laboratory technologists, ultrasound was calibrated before the procedure. The diagnosis of pregnancy was confirmed by Trans abdominal ultrasonography combined to the HCG.
Data quality was ensured during data collection, coding, entry and analysis. During data collection adequate training and follow up was provided to data collectors and supervisors. Incomplete checklists were returned back to the data collector for completion. Codes were given to the questionnaires and during the data collection so that any identified errors was traced back using the codes.
Data processing and analysis
Collected data were rechecked for completeness, consistency and coded before data entry. Data were entered using Epi data version 3.1 and data from five hospitals were merged together, then exported to the Statistical Package for Social Science (SPSS) version 23 for analysis. Descriptive analysis was conducted to explore the data and present some variables. Bi-variable binary logistic regression analysis was executed to select candidate variable for multivariable binary logistic regression to identify the predictors. Variables with p-value of less than 0.25 were selected for multivariable logistic regression. Odds ratio (OR) and 95% confidence intervals (CI) were used to describe the association between ectopic pregnancy and potential risk factors. Variables with a p-value <0.05 in multi-variable analysis was considered as a significant risk factor for ectopic pregnancy.