The study tool was developed in four phases (Fig. 1), and the activity was coordinated centrally by ICMR and C3/WRAI.
The first phase was the formative phase when the project team reviewed existing published literature including articles in peer-reviewed journals and available reports to collect evidence of RMC and its methodology from global and Indian literature. This helped to identify study tools used by researchers to measure RMC in facility births. A Technical Advisory Group (TAG) was constituted by ICMR in January 2017 consisting of subject experts, maternal health programme managers, women’s health groups, womens’ rights representatives and clinicians at the national and regional level, chaired by an external academic expert. The TAG agreed to validate, in an Indian setting, the internationally accepted classification used by the USAID flagship program - Maternal Child Health Integrated Program (MCHIP). This classification is derived from the landscape analysis by Bowser and Hill of D&A in facility-based childbirths in which they captured what is currently known on the subject, through literature review, structured group discussion, and in-depth interviews [5]. The authors identified seven different domains of D&A viz. physical abuse, non-consented care, non-confidential care, non-dignified care, discrimination, abandonment of care, and detention in facilities [5]. These domains are useful in identifying the gaps in RMC and deriving solutions. The tool developed by MCHIP measures compliance of RMC under these seven domains and is based on the observation of two women at a time by one observer throughout labor and delivery [13]. The MCHIP tool has seven performance standards, and each standard has respective verification criteria ranging from minimum one to a maximum of nine criteria. The criteria relate to the common observations of violations in RMC reported in the literature and correspond to the minimum level of care that should be offered to birthing women to provide the corresponding RMC standard.
In the second phase, a two-day National Stakeholders’ Workshop on RMC was jointly conducted by ICMR and C3/WRAI on April 20–21, 2017 at New Delhi to engage with various stakeholders to understand their views and their preparedness for RMC, and review and adapt the MCHIP study tool to Indian settings. A heterogeneous group of 85 participants with experience in providing maternity healthcare services attended the workshop. There was representation from the Federation of Obstetric and Gynecological Societies of India (FOGSI), the Trained Nurses’ Association of India (TNAI), WHO, USAID, the Ministry of Health and Family Welfare (MOHFW), Government of India, and obstetricians, nurses, medical social workers, woman’s health advocates and lay members from society, besides social science researchers from ICMR. The experts presented the available global and Indian evidence on RMC with facility heads sharing their experience and efforts on implementing RMC standards in their facilities.
At the beginning of the RMCI initiative, the understanding of RMC was very nascent in India, especially among practitioners. Not all the participants who attended the national stakeholders’ workshop - which was possibly the first workshop on the subject at the national level – were aware of RMC. Availability of any RMC standards and indicators were not considered important, and their dearth was not regarded as a violation of a woman’s right to respectful maternity care, indicating normalization of the violations. To mitigate this resistance, the facilitators adopted clinical scenarios, case studies, and role-plays to help develop sensitivities for RMC among the participants.
Thereafter, during the national stakeholders’ workshop, participants were divided into groups to review and adapt the MCHIP tool to the Indian context. During the group activity, the participants validated the applicability of all the seven domains to the Indian context and provided feedback on the verification criteria of the study tool under the seven domains The results of the workshop were collated and a tentative tool comprising of standards and adapted verification criteria was prepared.
Next, a draft manual was prepared, to be used by observers in the selected facilities, to record the RMC gaps and the related information during labor and delivery. The manual comprised of the revised tool with RMC standards and their respective verification criteria; a cover page to capture information on the infrastructure, the client load, the period of observations; and a comment section to identify the context of the identified D&A at the facilities.
In phase three, feedback on the tool was taken from twenty tertiary care public health facilities from across India. The process was undertaken in the following three steps:
Identification of study sites (Step 1): This activity was initiated through the ICMR’s Human Reproduction Research Centers (HRRCs) located in the Departments of Obstetrics & Gynecology of the respective medical college hospitals. The Principle Investigator (PI) communicated with thirty HRRCs for their willingness to participate in the RMC study. The interested departments were advised to obtain ethical approval from their local Institutional Ethics Committees. Twenty facilities with representation from different regions of India - North, South, East, and West - consented to participate in the study and submitted the ethics approval (Fig. 2).
Training of officers (Step 2): Each of the twenty sites identified one or two nodal officers who would coordinate the research study activities to be conducted in their facility. The identified nodal officers were medical doctors with experience in maternity care. These officers were working as Research Officers or faculty members in the Department of Obstetrics and Gynecology in their respective facilities.
The nodal officers of the selected sites were trained at New Delhi at a two-day training held at ICMR, to apprise them with the concept of RMC through didactic lectures and case discussions. During this training, the importance of RMC was highlighted, and the study methodology and study tools were discussed in detail and role-plays helped explore differing points of view of care. On the second day of the training, on-site observations were arranged in the labor room of the local medical college hospitals. This was done to give the participants hands-on experience in correctly employing the study tool to observe and record the types and frequency of violations of RMC standards. To ensure uniformity in assessing and recording gaps in RMC in the observed facility, the participants were sent to labor rooms in small batches along with one facilitator for thirty minutes each. Once the visit was completed, the participants returned to the training venue to discuss and deliberate on their findings, resolve queries, and address gaps.
The nodal officers were instructed on multiple aspects that were to be followed during observations in their respective sites. They were suggested to find a place to sit with a clear line of view, avoid intervening in the existing practices, avoid asking questions or explanations, or revealing their tasks or study tools to the staff being observed upon. In addition, some specific guidelines were made to avoid drawing the attention of staff in the labor room that may alter the behavior of the staff. It was specified that actual observations should be started only after the labor room staff is accustomed to the presence of the researchers. For this, they were advised to visit the labor room at odd hours and sit in the labor room premises for at least one hour without taking down any notes. Also, before each observation, the researchers were advised to sit inside the premises for at least 15 minutes before the actual time of starting the observation. The observers were instructed that the first step was to fill in the patient load data, after which actual observations could begin. The observers were also told that the majority of the observations should be noted down during the hour of observation, after which they should move to a separate room and complete filling in the study tool including the context of the observations. However, it was also clarified that if some violation was observed to be ongoing, it was necessary to capture it in the study tool in the labor room itself. The observations were to be later typed and a soft copy sent to the PI. Verbatim quotes recorded in the local language were to be translated into English. To maintain confidentiality, each facility was provided with a unique facility code.
Pilot testing of the study tool (Step 3): After the nodal officers were trained, they were asked to pilot test the study tool in their facilities, and send back three filled-in tools to the central coordinating team. To ensure adequate quality and completeness of data recorded, queries, when generated, were resolved with the sites through email, phone calls, or skype.
In the fourth and last phase, after considering the inputs received from the sites during piloting, the central coordinating team revised and finalized the study tool and the accompanying instruction manual for the observers. A code list for comments and cadre of health care provider observed was prepared and added to the instruction manual. The pilot-test findings led to changes in the wording of the tool to avoid double negatives and an additional place to record the remarks of the observer that would help in understanding the context of the behavior. A detailed instruction sheet was also prepared to be shared with the study sites.
After consultations with participating facilities, it was decided that the RMC violations would be noted separately for three different stages of the birthing process or labor i.e. pre-delivery, during delivery, and post-delivery. Thus, three separate forms were made for the 1st stage, 2nd /3rd stage, and 4th stage observations.
Each participating site identified the labor room complex, an area in which women are admitted for normal vaginal deliveries. Women in different stages of labor (i.e. pre-delivery, during delivery and post-delivery) are present in this complex. In most high-income countries, women stay on the same bed/birthing suite from the time of admission during labor and until they are discharged after delivery. However, in most public health care setups in India, as in some other countries, women change beds and rooms during their hospitalization for delivery in different stages of labor. Thus, typically each woman is assigned four different beds - first bed before delivery when she is in labor pain, second bed during delivery, third after delivery, and fourth in the ward till she is discharged for home. In the pre-delivery room, most women are in active labor, but no deliveries take place in this room. This is the period when a woman is kept under observation in the labor room premises. The delivery room is the room where most women have their delivery and a baby corner/resuscitation room is attached. The post-delivery room is the room where women with their newborns are shifted to remain under observation (for 2–4 hours) until shifted to the post-natal ward. Under the RMCI initiative, the observing officers were asked to use the revised study tool and visit all the rooms of the labor room complex, take note of the patient load, and then be present in the assigned room for recording observations.
Another meeting with TAG was held in August 2017, during which the TAG members reviewed the tool and approved it. The members were satisfied with the process of tool development and opined that the tool appears robust, and it will inform about the typology of disrespectful and abusive behaviors in the labor rooms settings of public health facilities in India.
The final study tool was employed in the observation study to document the typology of D&A in labor rooms, and to identify challenges, barriers, and facilitators in implementing RMC standards in the tertiary health care facilities of India.