Study setting: This study was conducted from October 2009 to March 2010 in four peri-urban communities in Karachi, Pakistan (18). These areas include coastal fishing villages and semi urban settlements within the city. The total population of these three settlements was 212,294.
Study design: This was a mixed method study with a qualitative and a quantitative component. The quantitative arm consisted of two cross sectional surveys conducted at baseline and towards the end of the study period after the implementation of the intervention. The qualitative component consisted of 6 FGDs, 2 each with women who bought CDKs and used in their home deliveries, women who did not buy CDKs and birth attendants.
Study population: All women who delivered in last three months and residing in the catchment area and providing written informed consent were eligible to be part of the baseline survey. The intervention cohort consisted of a random subset of women who were at least 24 weeks pregnant at the start of the study and planned to deliver within the catchment area. Uptake of CDKs was measured at the end of the study period.
Intervention: The first step in the intervention consisted of making the pre-assembled, CDKs available at convenient and accessible spots in the community. These mostly consisted of the local Kiryanas (General Stores). CHWs subsequently visited enrolled women thrice in the third trimester. First visit was done to confirm address, gestational age and take consent. This was followed by two additional visits which entailed discussions with the woman and other decision makers of the family to provide information and education regarding use of CDKs. The time and date of sessions were scheduled as per the participants’ convenience. The visits included discussion on: the kit, its contents, availability at the nearest kiryana, method to use it, price and cost effectiveness in preventing both maternal and newborn complications. Visual illustrations were used for explaining many of the concepts.
Data collection:
For the quantitative component, questionnaires were administered at home by CHWs both for the baseline survey and for the intervention cohort immediately after birth. Both tools had questions on sociodemographic characteristics, past medical and obstetric history of the mother, use of CDKs and information on events around the peri-partum period. Specific questions were asked about the place of delivery, person assisting the delivery and key decision makers in the family for seeking care during and after pregnancy. If CDKs were used, women were asked about the items that were most used. If CDKs were not used, mothers were inquired about the reasons for not using them.
A total of 6 focus group discussions were planned. Two were conducted with mothers in the intervention arm who used the CDK, two with mothers in the intervention arm who did not use the CDK and two FGDs were conducted with the birth attendants. Each FGD had around 5–7 participants and was conducted by the principal investigator herself along with a sociologist. Audio recording were done, and detailed notes were taken.
Data management: All survey data were double entered by two independent data entry operators using a customized data entry program developed using Epi info version 6.04 (CDC, USA) with consistency checks built in. A validation check comparing the two data sets was run and any discrepancies were resolved.
Sample size: Assuming a baseline uptake of CDKs to be 10%, 65% deliveries taking place at home, a 15% absolute increase in proportion of women using the kits enrolled in the study and delivering at home, setting power at 90% and alpha as 0.05 and inflating for 15% lost to follow up, we calculated a sample size of at least 600 in each survey.
Plan of analysis:
Plan of analysis: We compared baseline sociodemographic characteristics of the reference and the intervention group and change in uptake of the CDKs with the intervention. Within the intervention group, we identified factors that were associated with uptake of the CDK by using logistic regression between the two groups. All variables which had a p-value of less than 0.10 at univariate level were used to construct a multivariable regression model using backward elimination technique. Odds ratios with 95% confidence intervals are reported. Hosmer and Lemeshow teat was used to assess the final fit of the model. All analysis was done using SPSS version 16.
Data triangulation was done between quantitative and qualitative components to cross verify results and output from more than one source and to increase the credibility and validity of the data (19).
Ethical consideration: Ethical approval was obtained from Aga Khan University’s Ethical Review Committee. A written informed consent was obtained from all participants