Postpartum quality of life in Indian women after vaginal birth and cesarean section: a pilot study using the EQ-5D-5L descriptive system

This was a prospective pilot study of the QOL of postpartum women living in rural areas of the Indian states of Gujarat and Madhya Pradesh. Postpartum women were recruited in the two purposively selected districts of Ujjain in Madhya Pradesh and Surendranagar in Gujarat. Only women who lived within these district were included into the study to facilitate follow-ups in their community after discharge from hospital.

Women from Ujjain district in Madhya Pradesh who gave birth in April 2016 were recruited either in the government district hospital or the non-governmental teaching medical hospital of the district. In Gujarat, women who gave birth between July and November 2014 were recruited in a community health center and 14 private hospitals of Surendranagar district. Women were purposively selected to include vaginal births and cesarean sections in the sample. Vaginal births included vaginal births with episiotomies, but no forceps or vacuum assisted births. Cesarean sections included both emergency and elective procedures.

Women were approached three times after giving birth. Visits for an interview occurred 0–3 days, 3–7 days, and 21–30 days postpartum. The first administration of the EQ-5D-5L questionnaire was in the health facility. During the first interview socioeconomic, pregnancy and birth characteristics of the women were elicited. Follow-ups were conducted in women’s homes for discharged women, or in the health facilities for a minority of women who were still in the health facility at the scheduled follow-up times. At all visits, women were interviewed by the same research assistant.

The study was part of the MATIND research projected, which evaluated two large scale demand side financing programs for maternal health in India – the Chiranjeevi Yojana (CY) scheme and the Janani Suraksha Yojana (JSY) scheme [9]. Early stage MATIND research demonstrated that many women accessing the CY and JSY schemes lack formal education and are part of traditional Indian societies [10, 11], in which women often have low levels of autonomy and freedom of expression.

Health-related QOL was assessed based on women’s responses to the EQ-5D-5L questionnaire. The EQ-5D is a two-part instrument. Part one, the so-called descriptive system, is a self-assessment of today’s health along 5 pre-specified dimensions: mobility, self-care, usual activity, pain or discomfort, and anxiety or depression. For each dimension, the respondent selects one of 5 levels of incapacitation in the 5L version: no, slight, moderate, severe, or extreme problems. The combination of answers can result in 5⁵ = 3125 possible health states. Part two of the EQ-5D consists of a visual analogue scale (VAS) which can be used to obtain a visually guided self-rating of today’s health on a scale from 0 (worst) to 100 (best). Both parts of the EQ-5D instrument should be used together [12], but women in the pilot study women had difficulties to assess their health using a VAS. Thus, use of the EQ VAS was ceased within the pilot study.

We used the Hindi version of EQ-5D-5L health questionnaire with permission from the EuroQoL Group [13, 14]. The questionnaire was intended to be administered to each recruited woman by a trained research assistant at three points in time: 1, 7 and 21 days after birth or as close as possible to these dates. In practice, the first interview occurred between 0 and 3 days postpartum, the second interview between 3 and 7 days postpartum, and the final interview between 21 and 30 after women gave birth. Women’s characteristics were obtained at baseline from hospital records and staff as well as by interviewing women. Interviews took place in a language understood by both the woman and the research assistant. No sample size calculation was made for this pilot study.

Problem levels, reported by the postpartum women through answering the descriptive system of the EQ-5D-5L at three different points in time, were mapped to QOL weights based on a value set obtained from the general population in the United Kingdom by time trade-off valuation techniques. We used the United Kingdom value set due to the lack of an EQ-5D population norm for India [15]. Furthermore, we used a crosswalk value set that allows to link responses to the EQ-5D-5L with the existing value sets for the EQ-5D-3L [16], as only value sets for the 3-level version of the EQ-5D were available at the time of analysis.

Quality-adjusted life time was calculated based on days (QALDs) rather than years (QALYs) due to the brief postpartum period studied. QALDs were estimated on the individual-level by applying the area-under-the-curve method [17, 18]. The area-under-the-curve method was implemented summing up, by birth mode and episiotomy status, the areas of under the curves obtained from linearly connecting each woman’s QOL values from day 1 to day 21 postpartum.

To obtain comparable QALDs, despite some variation in the postpartum days when QOL data was collected, we standardized the reference period for which QALDs are reported to days 1 to 21 postpartum. For women surveyed in Gujarat, we used recorded interview dates to impute QOL weights for days 1 and 21 postpartum based on linear interpolation. In one instance, interpolation led to a QOL weight greater than one and was set to one, the weight for the best health status. For women surveyed Madhya Pradesh, we assumed that all interviews took place exactly 1, 7 and 21 days after birth.

In total, 231 women were recruited into the pilot study: 60 in Ujjain district of Madhya Pradesh and 171 in Surendranagar district of Gujarat. Seven women were excluded from the analysis: one woman who gave birth on the way to a hospital, two women who experienced a still birth or neonatal death, and four women who could not be contacted for follow-up interviews.

The final sample included 224 women, of which 178 (79%) gave vaginal birth and 46 (21%) gave birth by cesarean section. Socioeconomic, pregnancy and birth characteristics of these women are shown in Table 1. Women were aged 18 to 36 years. Those who had a vaginal birth were more likely to belong to a socially and educationally disadvantaged group and a poorer household. The state specific Indian poverty line considers several other factors than income, and similar portions of women in both birth groups were below poverty line.

The number of previous pregnancies ranged from 0 to 7 in both birth groups with the same median of one previous pregnancy. An episiotomy was reported by 67% of the women who gave vaginal birth and by one woman with a cesarean section. In the vaginal birth group, 10% of women experienced one or more of the following complications during their birth or pregnancy: premature rupture of membranes, preeclampsia signs, obstructed labor, malpresentation, oligohydramnios, previous cesarean section. By contrast, 87% of the women with a cesarean section had at least one of these complications that increase the likelihood of cesarean section. No women in the sample was diagnosed with eclampsia or had convulsions. Similar portions of 87% and 91% of the newborns were healthy in both groups 2–3 days postpartum. Cesarean sections were more likely to happen in a private hospital, associated with longer hospital stays, and all performed by a medical doctor.

The pilot study started administering both parts of the EQ-5D-5L questionnaire. We observed early in the study that participating women had difficulties with the VAS component of the EQ-5D questionnaire. Given the standard instructions, several respondents were uncertain of where to place a mark on the VAS. Therefore, a decision was made to pursue the pilot study further using only the descriptive system of the EQ-5D-5L questionnaire through which we obtained the results presented below.

As health care becomes more patient-centered, patient-reported outcomes such as QOL are becoming increasingly important [19, 20]. The few studies that assessed postpartum QOL in India prior to our study have used the MGI questionnaire [21, 22]. Related to a lack of research on postpartum QOL in Indian women [23], there is limited knowledge and experience on choice of a suitable questionnaire for the study postpartum QOL in India.

We tested using the generic EQ-5D questionnaire for postpartum QOL assessment in India by interviewing a convenience sample of rural women three times with the EQ-5D-5L descriptive system in their first month postpartum. The rationale behind testing the EQ-5D questionnaire for postpartum QOL assessment in rural Indian women was that existing specific instruments for postpartum QOL, like the MGI or MAPP-QOL questionnaire, can be impractical for large-scale use in low-literacy populations and in settings in which women have low levels of autonomy and freedom of expression.

The MGI measures subjective QOL and, unlike the EQ-5D, does not consist of a predefined checklist of problems. Specifically, the MGI consist of three steps during which a woman generates her own QOL index. Step 1 requires a woman to identify up to eight most important areas of her life that have been affected by having a baby, and to indicate if she thinks these areas are positive, negative, both or neither of these. Step 2 asks a woman to score, on a visual analogue scale from 0 to 10, how she has been affected in each identified area over the past month. Step 3 requires a woman to allocate 20 points across the identified areas, according to how important an area is to her QOL. Thus, applying the MGI requires settings in which women are able, have time and are given time to think about and articulate such issues. In studies including larger numbers of women with low levels of education and/or from conservative rural settings, applying the MGI could become difficult. Use of the MGI may, for instance, require significant time and prompting from skilled counsellors to support women in expressing their postpartum experience [24]. At the same time, counsellors need to avoid influencing the women’s choices and expression.

An exploratory study that evaluated the use of the MGI in urban India found that all interviewed women identified only 2 to 5 areas of their life that had been affected by their pregnancy, after much suggestion and stimulation by the counsellors. The women in the study were perceived to have conceptual difficulty in identifying any areas or aspects of life which were positively affected by the birth [22]. The MAPP-QOL questionnaire, in turn, another specific instrument for postpartum QOL assessment, is self-administered and requires women to be able to read and write, but in our pilot study 45% of women had no or at most five years of schooling.

As we deemed the use of the MGI and MAPP-QOL instruments unfeasible for data collection on postpartum QOL within the MATIND project, we tested the use of the EQ-5D-5L questionnaire with rural Indian postpartum women in the states of Gujarat und Madhya Pradesh. Choosing the EQ-5D tool for postpartum QOL measurement was a pragmatic choice: Firstly, the EQ-5D instrument is available in many languages. Secondly, it can be administered in a number of modes, including face-to-face and telephone interviews. Thirdly, the EQ-5D questionnaire is relatively easy and quick to apply in comparison to the MGI or MAPP-QOL instruments. In addition, there had been some experience with using the EQ-5D questionnaire to evaluate postpartum QOL, yet mostly from high income countries [25‐28].

The findings of the pilot study at hand indicate that the descriptive system of the EQ-5D-5L was able to depict and differentiate early postpartum QOL in Indian women by birth mode and over time. On average, at least 75% of the women in our study reported slight to extreme problems in four of the five health dimensions assessed by the EQ-5D-5L. The median woman who gave vaginal birth reported slight problems with mobility, self-care, usual activities, and pain or discomfort in the first interview 0–3 days after birth. At a similar postpartum time, the median woman who gave birth by cesarean section reported slight problems only with pain or discomfort and extreme problems with mobility, self-care and usual activities. No problems with anxiety or depression were reported by the median women in both birth groups, and less than 3% of the women interviewed ever reported more than slight problems with anxiety or depression. Among the women who gave vaginal births, the EQ-5D based QOL measure was lower for women who reported to have had an episiotomy during birth in comparison to those women who did not have this oftentimes discomforting procedure. Differences in the level of problems, and consequently QOL weights, between women with vaginal births and women with cesarean sections were highest at the time of the first interview which took place within the first three days postpartum. As time progressed, differences in QOL between women with vaginal and cesarean births narrowed and ceased to be statistically discernible at the time of the last follow-up interview when adjusting for socioeconomic, pregnancy and birth characteristics. Estimating the overall QOL in the first 21 days postpartum, vaginal births were associated with significantly more QALDs than cesarean sections.

The differences and trends in the postpartum QOL of Indian women, which were measured using the EQ-5D-5L in this pilot study, reflect plausible outcomes that are consistent with the findings of prior studies of postpartum QOL, conducted in other settings and/or using other QOL instruments [4‐6]. Anxiety or depression was the EQ-5D dimension that was least affected by problems in our study. A recent systematic review and meta-analysis of postpartum depression in India, which included mostly studies that have used depression specific instruments, suggests a prevalence of postpartum depression of 22% (95% CI: 19%, 25%) overall and of 17% (95% CI: 14%, 21%) in rural areas [29]. In our study of the first postpartum month, 17% of women after vaginal birth and 26% after cesarean section reported slight to severe problems with anxiety or depression at the time of the first interview. By the end of our one-month pilot study, 97% of all women interviewed reported no problems with anxiety or depression. A decrease in the prevalence of possible depression within the first weeks postpartum is also suggested by the most comparable study, in terms of state and timing, of postpartum depression in the systematic review and meta-analysis. Using the Edinburgh Postnatal Depression Scale (EPDS), a prevalence of depression of 11%, 7% and 3% was found on postpartum days 1 and 6 and postpartum week 6, respectively, among randomly selected postpartum women in the Government Medical College in Gujarat [30], the state in which we recruited 74% of the women in our pilot study.

The fact that mostly slight if any problems with anxiety or depression were reported in our pilot study raises the question if the EQ-5D descriptive system is sensitive enough to detect changes in postpartum problems with anxiety or depression relevant to the QOL of Indian women. A systematic review of the EQ-5D responsiveness classified the overall responsiveness of the instrument to anxiety and depression disorders as small to large [31]. Future research might therefore need to study the existence and relevance of a possible lack of sensitivity in the anxiety or depression dimension when using the EQ-5D for postpartum QOL assessment in rural Indian women. Stigma expressing postpartum anxiety or stress, particularly when interviewed at home rather than in a hospital environment, could be a possible limitation to assessing problems with anxiety or depression in India [29]. Besides, difficulties to differentiate between postpartum blues and postpartum depression in the early postpartum period [29] might confound early postpartum period responses to questions about anxiety or depression. On the other hand, some researchers argue that postpartum stress in India can be low due strong extended family support during seminal moments in life like childbirth [32].

To our knowledge, this study was the first to assess postpartum QOL using the EQ-5D in a low resource setting. As a pilot study, this study has several limitations. Only part the EQ-5D questionnaire (the descriptive system) was assessed, and no validation whether the EQ-5D descriptive system measured postpartum QOL in Indian women accurately and consistently was performed. We can therefore not exclude that the descriptive system of the generic EQ-5D instrument failed to measure or inadequately measured health-related problems of Indian women in the postpartum period (see [33]). Further, due to the unavailability of an EQ-5D population norm, which would reflect the preferences over health states of the general public for India, a United Kingdom value set was used as an approximation to obtain QOL weights from the gathered problem levels. Finally, the pilot study’s sample, sample size and time horizon were pragmatic choices. Districts, health facilities and women were selected such that they could be reached well by research assistants. Applying a convenient sampling procedure resulted in a sample in which, for instance, the majority of women gave birth in a private health facility and all women with a cesarean section were primipara. While we adjusted for selected baseline differences in a multivariate analysis, there may be other confounders and lack of variation or statistical power in the data that influenced the results. The study was restricted to 4 weeks for logistical reasons even though the immediate postpartum period is commonly defined as up to 6 weeks after birth. However, 87% of all women in the study reported no problems in all five EQ-5D domains during the last interview. Therefore, impairments to QOL in the immediate postpartum period that can be measured with the EQ-5D-5L descriptive system appear to have been measured to a large extent in this pilot study. Changes in later postpartum QOL, beyond the immediate postpartum period, have not been studied.