This study was approved by the Stanford University Institutional Review Board.
Study activities took place at the Instituto Guatemalteco de Seguridad Social (IGSS) Pamplona hospital in Guatemala City, Guatemala. Data collection was overseen by Stanford University and IGSS hospital faculty.
IGSS Pamplona is a large, tertiary academic hospital that manages approximately 8000 to 9000 deliveries per year. It is considered a high-risk hospital that receives referrals from neighboring hospitals for complicated pregnancies. IGSS Pamplona does not have an Adult Intensive Care Unit (ICU), however, and sends postpartum ICU patients to an affiliated, nearby sister site. IGSS Pamplona has PPH management protocols in place that are based on World Health Organization (WHO) and national guidelines.
The Global Outreach-Mobile Obstetrics and Medical Simulation (GO MOMS) program is a SBT program developed at Stanford University to provide a standardized obstetrical and gynecological training tool for faculty and resident learners within teaching hospitals in low-resource settings . Topics covered in GO MOMS include B-Lynch, uterine balloon tamponade (UBT), management of pre-eclampsia/eclampsia, shoulder dystocia, placement of foley catheters for cervical ripening, and maternal cardiac arrest. A needs assessment was carried out prior to the first GO MOMS course in Guatemala. This revealed that PPH was a leading cause of morbidity, thus GO MOMS directed a large component of the SBT to addressing PPH management. Through SBT, GO MOMS teaches the techniques of B-Lynch suture and uterine balloon tamponade (UBT), recommended for the treatment of PPH by the WHO and others [15, 16]. For UBT, two techniques were taught using different devices: 1) Bakri balloons and 2) condom-catheter uterine balloon tamponades. Both devices were demonstrated given that access to Bakri balloons is limited in many places and condom-catheter UBTs may be more accessible but require additional steps for assembly.
The intervention group consisted of Guatemalan OB/GYN residents and/or attending physicians who had participated in the GO MOMS simulation program at least once prior to 2019 (and who were participating in GO MOMS training again in 2019) (n = 24). The comparison group consisted of Guatemalan OB/GYN residents or attending physicians who had not yet participated in the GO MOMS simulation program (and who were participating in the program for the first time in 2019) (n = 15). The 2019 GO MOMS simulation program was held at a large conference, and individuals could opt in or out of participating in our study after completion of the GO MOMS simulation training session.
Study information was provided to all participants. They were informed that we were conducting a study to help improve simulation training programs and evaluate experiences of participants. Verbal consent was obtained for all participants for both the multiple-choice knowledge survey and qualitative components of the study.
Multiple-choice knowledge survey
A multiple-choice knowledge survey was designed to gather demographic information, practice patterns, prior training, knowledge, and experience with B-Lynch, UBT, and medical abortion (for the management of spontaneous abortion). The data on medical abortion will be published separately.
For the multiple-choice knowledge survey, we utilized convenience sampling by allowing all residents and attending physicians participating in the GO MOMS program in 2019 (some of who had also participated in the GO MOMS program prior to 2019) to participate in the study. Study participants completed the multiple-choice questionnaires via REDCap in September 2019. The Stanford REDCap platform (http://redcap.stanford.edu) is developed and operated by the Stanford Medicine Research IT team. Participants completed the RedCap survey using a laptop computer, iPad, smartphone, or via pen and paper. Study participants who completed the REDCap surveys could “opt-in” to also participate in qualitative interviews.
A qualitative interview guide was designed to gather information concering challenges, positive experiences, and attitudes of providers around B-Lynch and UBT. The qualitative interview guide included question prompts and interviewer scripts.
A purposeful sampling strategy was utilized for the qualitative interviews. Our goal was not to generalize to a population with statistical confidence, but to select an information-rich population. This was deemed appropriate for our study as we sought to understand perspectives and in-depth points of view around provider experiences with implementation of B-Lynch and UBT for PPH beyond the multiple-choice knowledge survey alone . We selected OB/GYN residents or attending physicians who had participated in GO MOMS training in the past (at least once prior to 2019) to gain more information about their experiences incorporating knowledge gained from GO MOMS into clinical practice.
All qualitative interviews were conducted using the qualitative interview guide via an interpreter fluent in Spanish with the support of a research assistant who speaks English. Interviews were audiotaped, translated into English, and transcribed by study personnel.
Multiple-choice knowledge survey and qualitative interview
For both the multiple-choice knowledge survey and the qualitative interview guide, all questions were written in English and validated via peer review by U.S. board-certified OB/GYNs for accuracy. The questionnaires were translated into Spanish and reviewed by IGSS faculty. A back translation was performed to ensure that the questions asked in Spanish represented the same content and meaning as those in English.
For the multiple-choice knowledge surveys, Fisher’s exact test was utilized with p < 0.05 considered statistically significant. Analyses were performed using SAS Enterprise Guide 7.1 (SAS Institute Inc., Cary, NC).
For the qualitative interviews, grounded theory methodology, as described by Charmaz , was utilized for data analysis. This method of qualitative analysis is constructivist, as it generates concepts and theories from data. Two independent investigators carried out the qualitative analysis by conducting line-by-line coding of interview transcripts. Preliminary themes were then developed by grouping similarly coded phrases. Emergent concepts were then derived by grouping preliminary themes into categories. One investigator was fluent in Spanish and English to ensure that any lack of clarity surrounding the translated content could be addressed. Investigators who participated in coding had prior experience in qualitative methods and conducting OB/GYN-related research.