Study area and period
The study was conducted in Tigray Public Health institutions. Tigray is located in the Northern part of Ethiopia and around 783km away from the capital city Addis Ababa. Around 5.5 million people are found in this region (census 2007). The region is the owner of 216 health centers, 15 General Hospitals and 2 Referral Hospitals. Among the selected zones (southern, Mekele & southeastern zones ) there are about 61 health centers , 5 Primary Hospitals, 1 Referral Hospital and 6 General Hospitals. The study was conducted from July 1, 2017 to December 2018.
Cohort study design was employed (retrospective & prospective)
Source population were women who come up for labour and delivery services in Tigray Public Health institutions
Exposed group: Mothers who came to the health facility for delivery services whose first visit antenatal care guideline was complete.
Non-exposed group: Mothers who came to the health facility for delivery services whose first visit antenatal care guideline was incomplete.
- All selected women who come for labour and delivery services in Tigray public health institutions.
- Non-exposed group: All selected mothers coming to the health facility for delivery services whose first ANC guideline visit was incomplete
- Exposed group: All selected mothers coming to the health facility for delivery services whose first ANC guideline visit was complete.
All women coming for delivery services in the public health facilities
Women who has known medical illness (DM, HTN, CLD)
Sample size determination and Sampling procedures
Sample size was calculated using double population proportion formula for cohort study considering the following assumptions:
A one-to-two ratio of exposure to non-exposure.
Since there is no documented evidence in the setting, it is assumed that the complication rate was twice as high amongst the unexposed group (incomplete adherence) as compared to exposed group (complete adherence).
By taking prevalence of pregnancy complication (PIH/preeclampsia-eclampsia) among the mothers with complete adherence to be 5.1% from previous study in Ghana (11).
The final total sample size is 1002; multiplying by 1.5 of design effect the final result is 1503; 501 for exposed group and 1002 for non- exposed group.
Among these sample size 5 was lost during follow up for the exposed group and 42 extra samples was added to the non-exposed groups during selecting of the samples , finally 496 participants had completed their follow up for exposed groups and 1044 for non-exposed groups. A total of 1540 participants had completed the cohort follow up.
Simple random sampling was used to select the study site and population proportion distribution was used for each selected health facility. Convenient sampling method was used to select the study participants. Women who have complete adherence to the first antenatal care guideline were considered as exposed group whereas those with incomplete adherence were considered as non-exposed group. Exposed and non-exposed mothers who fulfill the inclusion criteria were enrolled to the cohort study. Those selected participants were followed until the end of postpartum period (six weeks after delivery). Among the seven zones of the region 40% was selected by simple random selection technique. In this selected zones there are about 73 health facilities. By using simple lottery method 20 of them were selected. The sample size was distributed to each selected health facility by probability proportion to size (PPS) according to their ANC flow rate.
Data collection tool and measurement
In this study, participants were interviewed using interview guide for their socio-demographic variables and a checklist was used to score provider adherence to antenatal care guidelines. Adherence to first antenatal visit guidelines was used as a proxy for adherence to guidelines in general. The questions on the checklist are based on the requirements for first antenatal visit as per the safe mother practice (SMP) and WHO focused antenatal care guideline. After recruiting the study participants to the exposed and non-exposed groups, they were followed till the end of the postpartum period (six weeks after delivery).
Data collection process
Every woman who got delivery services at the health facilities on any day, who met the inclusion criteria and provided informed consent for participation, were enrolled into the study. At recruitment, during the first antenatal visit professionals’ performance to first antenatal visit was assessed using a standardized checklist from women’s card to determine level of providers’ adherence. All women were followed until 6 weeks postpartum to complete data collection on outcomes. Follow up were made during delivery, at sixth postpartum day and sixth postpartum week in the respective health institutions. In case of disappearance participants were given phone calls to trace them. 20 BSc degree midwives were recruited as data collectors. Similarly 3 MSc holders were assigned to supervise the data collection process. Data was collected from the antenatal card, by asking the mother directly and by following the mother prospectively until 6 weeks postpartum.
Adherence level of health care providers and perinatal outcome
Socio-demographic factors (age, educational level, marital status and employment status)
Maternal factors (parity, trimester at first antenatal care visit, previous pregnancy history and number of times antenatal clinic was attended during pregnancy)
Neonatal factors (mode of delivery, duration of delivery, place of birth)
Level of adherence: Each variable adhered to, scored a point of 1 while non-adherence scored 0. A total score of 18 was considered as complete adherence to guidelines. Non-adherence to any of the variables was classified as incomplete adherence.
Antenatal complication: having at least one of the following: anemia in pregnancy, pregnancy induced hypertension/pre-eclampsia/eclampsia, malaria in pregnancy, ante partum vaginal bleeding, malaria, IUFD/IUFG, PROM, Preterm labor.
Delivery complication: having at least one of the following: pregnancy induced hypertension/pre-eclampsia/eclampsia, ruptured uterus, and obstructed labor, vaginal tears, perineal tears, C/S, DD.
Post-delivery complication: having at least one of the following: postpartum hemorrhage, anemia, malaria, PIH & sepsis
Neonatal complication: having at least one of the following: preterm, post-maturity, low birth weight, neonatal jaundice, asphyxia, still birth and neonatal mortality.
Data processing and management
Epi data version 3.5.1 software was used for data entry and it was analyzed by SPSS version 20 software. Descriptive analysis was presented using mean and proportions. Data were presented using tables, figures and texts. Determinants of maternal and neonatal complications, as well as the effect of complete adherence on pregnancy outcomes was estimated and expressed as relative risks (RRs) with their 95% confidence intervals (CI). Binary logistic regression was used to see the association between variables. Significance was declared at P-value <0.05.
Data quality assurance
A standardized English version measuring questionnaire was adapted and translated into Tigrigna (local language) by experts then translated back to English to check for consistency. The questionnaire was reviewed by senior researchers and comments were incorporated for internal validity. In addition pre-test was done in 10% of the calculated sample size. Data collectors and supervisors were trained for 3 days on the tools and process of data collection. Collected data were checked by the supervisor and principal investigator for completeness of the data.
Ethical clearance was obtained from the institutional review board of Mekele University, College of Health Sciences and support letter was given by the Tigray Regional Health Bureau to the respective administrations of the health facilities. All participants were informed of the objective, anonymity of the study and they were also informed that they are free to withdraw at any time if they want to do so. Finally written informed consent was obtained from the participants.