Methods for the study can be broadly explained under two headings according to objectives of the study:
-
a)
Development of the ANC handbook
-
b)
Pretesting of the ANC handbook
a) Development of the ANC Handbook
The first step in developing the ANC handbook involved literature review regarding theoretical framework of different components of antenatal care, the type of different antenatal care record keeping, and information giving instruments/materials available at the community and health facility levels in Pakistan.
The ANC handbook is comprised of two major sections, i.e. the Pregnancy Record Card (PRC) and the Pregnancy Education Card (PEC). The PRC was developed for monitoring the health of pregnant women during the course of pregnancy. The inclusion of items comprising the PRC was based on the theoretical understanding of antenatal care from a biomedical perspective. It contained variables to record the history of the past and present pregnancies, information regarding clinical tests, medications, and other relevant aspects pertinent to pregnant women.
The PEC was developed for encouraging good health habits, providing health education, and offering support to pregnant mothers. The content of the PEC was composed of pregnancy, child birth, and child spacing related messages which were accompanied by culturally appropriate sketches. Message specific illustrations were designed by a graphic artist.
In order to ensure that each component of the ANC handbook was administered and recorded in a predetermined and consistent way, both the PRC and PEC were accompanied by their corresponding manual of instructions. The Manual of Instructions for PRC contained instructions for understanding as well as administration of each of its items, its purpose, and method to administer and record. It also included helpful hints in case of difficult variables. For example, if a health worker has to ask the date of the last menstrual period from an expectant mother, she would learn its purpose in calculating the stage of pregnancy, and also in estimating the expected date of delivery so that delivery related arrangements can be made. The recording instruction would ask her to note the date in terms of day, month, and year format. The associated helpful hint would guide her to relate it to local calendar and specific religious/cultural events that have taken place recently if the expectant woman doesn't remember the exact date of the last menstrual period. The Manual of Instructions for PEC provides detailed information related to an educational message so that if expectant women have any difficulty in understanding a particular message or wants to learn more about it, the health worker should be able to do so.
For making the ANC handbook presentable, convenient, easily understandable, and succinct, a detailed workup on the finalization of the layout was carried out. After the title page, the first section of the ANC handbook is the PRC followed by the PEC which was arranged in a pregnancy trimester specific manner. The number of pages of the PEC were three (i.e. a single page specific for each pregnancy trimester). This was done in the light of the evidence that trimester specific messages are more easily understood by women with low literacy and socioeconomic status as it reduces the amount of information while also making it relevant for the immediate period of pregnancy [50].
Once the PRC, PEC, and their respective manual of instructions were ready, these were then translated into the national language (Urdu), which is widely spoken and understood in the country. The translation of the handbook components back into English was done by independent researchers.
Intended operationalization of the ANC handbook
The ANC handbook was developed to be utilized by frontline community health workers (such as Lady Health Workers and Midwives) as well as facility based Lady Health Visitors and other senior health staff. The uniqueness of the ANC handbook is that it can be used uniformly across different tiers of the health system in Pakistan; whether community based or hospital based. The intended operationalization of the ANC handbook is that the expectant mothers will keep a copy of PRC and similarly, a copy will be retained by staff at the nearest public/private health facility. Hence, after examining the expectant mother, the staff will be able to record their findings on both copies of the record. The copy with the expectant woman will ensure quick availability of obstetric history in case of emergency besides creating a persistent awareness of importance of woman's own as well as the baby's well-being. The copy at the health facility will ensure the availability of pertinent information in case the expectant woman's copy is lost and will also form an important component of pregnancy related statistics. During the same visit when pregnancy related technical information will be recorded, reinforcement of the information contained in the PEC will also be carried out (a sample page from PEC is given as additional file 1).
Pilot testing
A small scale pilot test was undertaken as recommended by van Taijlingen and Hundley [51] to check if the developed instruments have any unforeseen problems such as wording or flow of the items, as well as to see if the proposed methodology is feasible. Pilot testing of the ANC was carried out using the same techniques as were used to test the instruments in real settings. PEC was administered to 15 pregnant women at a private health facility (that was not included in the study conduct sites) along with 5 obstetricians and nursing staff each.
b) Pretesting of the ANC Handbook
In order to determine whether the expectant mothers found the sketched message illustrations in the PEC to be culturally appropriate and relevant, and whether the health staff working at different facilities found it workable in the health system, we adopted a cross-sectional approach. Traditionally, it is considered valuable to divide pregnancy into three equal parts called trimesters, each trimester being three months long. This classification identifies the important obstetrical milestones easily [15]. Hence, it was essential to include a sample representative of all trimesters.
A convenient sampling strategy was adopted because no sampling framework of pregnant women was available in the study communities. Our total sample was 300 pregnant women with equal representation from each pregnancy trimester. Keeping in view the potential differences among the pregnant women who utilize antenatal care and those who don't, we recruited 150 women from the community arm and 150 from the health facility arm. Each arm is further divided to include 50 women from all pregnancy trimesters to cover the entire spectrum of pregnancy (see Figure 1).
A team of eight female data collectors was recruited. These included sociologists, midwives, and other field staff who have past experience in doing field research related to maternal health. They were given two days training in which all the components of the ANC handbook were described in detail. The selection criteria, procedure for taking informed consent, and other data recording methods were explained in detail.
Data collection
Our data collection period lasted from 06 May to 05 June of 2004, and it included both the health facility and community arms. The pretesting of the two components of the ANC handbook was carried out in the following manner:
Pretesting of PEC
Health facility arm
For the achievement of the sample needed from the health facilities, three primary health care centres (namely Sultanabad, Hijrat Colony, and Rehri Goth), one government maternity home (PIB colony), and an outpatient department of a tertiary care hospital from Karachi (Community Health Centre-Aga Khan University Hospital) were used as study sites. The selection of these sites was based on the diversity of population they were serving, presence of a functional antenatal care service, and time/logistical constraints. The eligibility criteria encompassed pregnant women visiting the centre for antenatal check up and who gave informed consent verbally. The first page of the study questionnaire contained a standard paragraph regarding the purpose of the study, assurance regarding confidentiality of the participants' information, and voluntary participation (if the women had any questions regarding participation in the study then these were also answered by the field workers). It further included a statement regarding whether the study participant had consented to participate in the study. The field workers read out the standard paragraph to the pregnant women, and asked for their voluntary participation in the study. If the woman agreed for participation in the study, the questionnaire was marked and the interview proceeded. After the collection of information on socio-demographic variables, and, past and current obstetric history, the women were given PEC to review for some time on their own. When they finished reviewing the material, the field worker asked their understanding of each sketch and accompanying health education message. The results were noted as 'understandable', 'not understandable' and 'comments'.
Community Arm
Data were collected from the squatter settlements of Manzoor Colony and Qayumabad, Karachi for the community arm portion of the study. These sites were selected as they present a good mix of major ethnicities of Pakistan with inhabitants mostly belonging to low socioeconomic status with high levels of illiteracy and poverty. An adequate mix of public and private antenatal care providing facilities was also present at these field sites.
Pregnant women were identified by doing door to door mapping. The selection criteria encompassed pregnant women who were not receiving antenatal care for the current pregnancy, were not planning to seek routine antenatal care, and who gave informed consent verbally (the process of taking and recording the informed consent was same as described under the heading of health facility arm). During data collection, the field workers collected background sociodemographic, past and current obstetric history related variables in the questionnaire. In order to determine its understanding by the target population, the sketched illustrations and accompanying health education related messages were given to the expectant mothers. The opinion of the expectant mothers regarding sketched illustrations and health education related messages was noted in the questionnaire as 'understandable', 'not understandable', and 'comments'.
Pretesting of PRC
Owing to the technical nature of the contents of the PRC, its field testing was carried out by presenting it to health care staff of different levels of health facilities. The staff of the health facilities mentioned in the hospital arm: 3 primary health care centres (Sultanabad, Hijrat Colony, and Rehri Goth), one government maternity home (PIB colony) and an outpatient department of a tertiary care hospital from Karachi (Community Health Centre-Aga Khan University Hospital) participated in testing of PRC. They were given PRC one day prior to collecting data from them so as to give some time for content review and also to minimally affect their routines at the clinics. On the day of pretesting, after doing antenatal assessment of the expectant women, the health care staff recorded the information on PRC to check its completeness and user friendliness. A total of 25 health care staff participated in the pretesting of PRC. These included Community Health Nurses, Midwives, Health Technicians, Registered Nurses, Lady Health Visitors, General Physicians and Obstetricians who were working in the primary health centres, maternity homes and hospitals.
Quality Assurance
The data collection team was supervised in the field by the authors. Their tasks included accompanying the field workers and observing them, cross checking the collected data, clarification of ambiguities, and the identification of missing information. Data were edited in the office for consistency, accuracy, and identification of the out of range entries (for example mention of past obstetric history related variable if the respondent was a primigravida). In case of missing information, the field workers were advised to go back to that particular study participant and complete the required information. For data validation, double entry was done in MS access, and to identify any inconsistency in data entry, 5% of the records were re-entered.
Ethical Considerations
Ethical review and formal permissions for the conduct of study were taken from all the participating institutions according to their specific protocols, including the ANC handbook which was shared with the management of the health facilities in advance. Informed consent was taken from all study participants. Involvement in the study was voluntary, and in case of refusal, the participant's decision was respected. The refusal rate was less than 1 percent of the total sample in the community as well as health facility arm. The study participants who were identified as having high-risk conditions were referred to seek expert advice. The messages given in the 'PEC' were reinforced. Field workers were trained not to disclose study participants' information with any other person in order to maintain confidentiality. Data were entered and analyzed in an anonymous manner so as to protect the identity of the study subjects.
Data were analysed using quantitative and qualitative techniques. Quantitative analysis was done using SPSS version 14.0. Mean and standard deviation of continuous variables such as age, and proportion of categorical variables (such as religion, ethnicity and literacy status) were calculated. Chi square test was used to compare any significant difference between women in the community and the health facility arm. A P value of <0.05 was considered as significant. Comments of the respondents regarding each message of the PEC were compiled and common themes were identified for appropriate modification.