An effectiveness-implementation hybrid type 1 trial assessing the impact of group versus individual antenatal care on maternal and infant outcomes in Malawi.

BACKGROUND: Sub-Saharan Africa has the world's highest rates of maternal and perinatal mortality and accounts for two-thirds of new HIV infections and 25% of preterm births. Antenatal care, as the entry point into the health system for many women, offers an opportunity to provide life-saving monitoring, health promotion, and health system linkages. Change is urgently needed, because potential benefits of antenatal care are not realized when pregnant women experience long wait times and short visits with inconsistent provisioning of essential services and minimal health promotion, especially for HIV prevention. This study answers WHO's call for the rigorous study of group antenatal care as a transformative model that provides a positive pregnancy experience and improves outcomes. METHODS: Using a hybrid type 1 effectiveness-implementation design, we test the effectiveness of group antenatal care by comparing it to individual care across 6 clinics in Blantyre District, Malawi. Our first aim is to evaluate the effectiveness of group antenatal care through 6 months postpartum. We hypothesize that women in group care and their infants will have less morbidity and mortality and more positive HIV prevention outcomes. We will test hypotheses using multi-level hierarchical models using data from repeated surveys (four time points) and health records. Guided by the consolidated framework for implementation research, our second aim is to identify contextual factors related to clinic-level degree of implementation success. Analyses use within and across-case matrices. DISCUSSION: This high-impact study addresses three global health priorities, including maternal and infant mortality, HIV prevention, and improved quality of antenatal care. Results will provide rigorous evidence documenting the effectiveness and scalability of group antenatal care. If results are negative, governments will avoid spending on less effective care. If our study shows positive health impacts in Malawi, the results will provide strong evidence and valuable lessons learned for widespread scale-up in other low-resource settings. Positive maternal, neonatal, and HIV-related outcomes will save lives, impact the quality of antenatal care, and influence health policy as governments make decisions about whether to adopt this innovative healthcare model. TRIAL REGISTRATION: ClinicalTrials.gov registration number NCT03673709. Registered on September 17, 2018.

Reasons Why Pregnant Women Participate in Ultrasound Research Involving Transvaginal Scans.

OBJECTIVES: The aim of this study was to explore the motivations of pregnant women in participating in an ultrasound study and the acceptability of vaginal ultrasound examinations. METHODS: A prospective sample of 270 women were asked one question: "Can you tell me what motivated you to participate in the study?" The data were then analyzed through a qualitative thematic analysis with an inductive approach. In addition to the thematic analysis, quantification of the data was performed to enhance the qualitative result. RESULTS: Through the thematic analysis, 5 themes emerged from the responses of the participants: altruism, research, personal experience, personal benefit, and finding out. All responses were relatively short, and some responses included more than one theme. CONCLUSIONS: Vaginal ultrasound examinations were acceptable to the participants, and pregnant women had many motivations to participate. Regardless of race, ethnicity, or insurance status, the women in our study were altruistic and curious about our research.

Randomized controlled pilot of a group antenatal care model and the sociodemographic factors associated with pregnancy-related empowerment in sub-Saharan Africa.

BACKGROUND: The links between empowerment and a number of health-related outcomes in sub-Saharan Africa have been documented, but empowerment related to pregnancy is under-investigated. Antenatal care (ANC) is the entry point into the healthcare system for most women, so it is important to understand how ANC affects aspects of women's sense of control over their pregnancy. We compare pregnancy-related empowerment for women randomly assigned to the standard of care versus CenteringPregnancy-based group ANC (intervention) in two sub-Saharan countries, Malawi and Tanzania. METHODS: Pregnant women in Malawi (n = 112) and Tanzania (n = 110) were recruited into a pilot study and randomized to individual ANC or group ANC. Retention at late pregnancy was 81% in Malawi and 95% in Tanzania. In both countries, individual ANC, termed focused antenatal care (FANC), is the standard of care. FANC recommends four ANC visits plus a 6-week post-birth visit and is implemented following the country's standard of care. In group ANC, each contact included self- and midwife-assessments in group space and 90 minutes of interactive health promotion. The number of contacts was the same for both study conditions. We measured pregnancy-related empowerment in late pregnancy using the Pregnancy-Related Empowerment Scale (PRES). Independent samples t-tests and multiple linear regressions were employed to assess whether group ANC led to higher PRES scores than individual ANC and to investigate other sociodemographic factors related to pregnancy-related empowerment. RESULTS: In Malawi, women in group ANC had higher PRES scores than those in individual ANC. Type of care was a significant predictor of PRES and explained 67% of the variation. This was not so in Tanzania; PRES scores were similar for both types of care. Predictive models including sociodemographic variables showed religion as a potential moderator of treatment effect in Tanzania. Muslim women in group ANC had a higher mean PRES score than those in individual ANC; a difference not observed among Christian women. CONCLUSIONS: Group ANC empowers pregnant women in some contexts. More research is needed to identify the ways that models of ANC can affect pregnancy-related empowerment in addition to perinatal outcomes globally.

Experiential Training Workshops for Group Antenatal Care in Malawi.

The positive effects of the CenteringPregnancy group antenatal care (ANC) model on perinatal outcomes in the United States has led to its adaptation and implementation in many low- and middle-income countries. Facilitative discussions are a core component of this group ANC model. Facilitator training lays a critical foundation for delivery of this paradigm-shifting model as practitioners learn to adapt their approach to health education from didactive to facilitative. However, there is little rigorous research focused on best practices for training group health care facilitators and none that is guided by a theoretical framework. Kolb's experiential learning theory offers a theoretical framework to guide the development of training workshops that allow trainees to experience, reflect on, and practice the facilitation skills needed to deliver this evidence-based intervention. This article describes an experiential learning-based training workshop that was implemented as part of an ongoing effectiveness-implementation trial of a Centering-based group ANC model in Blantyre District, Malawi. We provide a blueprint for conducting group ANC facilitator trainings that, in addition to imparting knowledge, effectively builds confidence and buy-in to this paradigm-changing approach to ANC delivery. This blueprint can be adapted for use in designing and implementing group health care across settings in the United States and globally.

Impaired Lactation: Review of Delayed Lactogenesis and Insufficient Lactation.

It is estimated that as many as 1 in 20 women worldwide are unable to successfully breastfeed or provide adequate nutrition for their infants through their breast milk alone. Compromised nutrition in the early stages of life places the infant at risk for insufficient growth as well as serious and potentially disabling or life-threatening complications. This review summarizes risk factors associated with impaired lactation that may result in either delayed lactogenesis or insufficient lactation. The risk factors for insufficient lactation are categorized into preglandular, glandular, and postglandular causes. Impaired lactation can occur despite maternal motivation, knowledge, support, and appropriate breastfeeding technique. Although there is no clear way to predict who will experience impaired lactation, knowledge about the risk factors can enable health care professionals to better identify at-risk mother-infant dyads. Early intervention may help prevent infant complications associated with inadequate nutritional intake.

Building a Global Evidence Base to Guide Policy and Implementation for Group Antenatal Care in Low- and Middle-Income Countries: Key Principles and Research Framework Recommendations from the Global Group Antenatal Care Collaborative.

Evidence from high-income countries suggests that group antenatal care, an alternative service delivery model, may be an effective strategy for improving both the provision and experience of care. Until recently, published research about group antenatal care did not represent findings from low- and middle-income countries, which have health priorities, system challenges, and opportunities that are different than those in high-income countries. Because high-quality evidence is limited, the World Health Organization recommends group antenatal care be implemented only in the context of rigorous research. In 2016 the Global Group Antenatal Care Collaborative was formed as a platform for group antenatal care researchers working in low- and middle-income countries to share experiences and shape future research to accelerate development of a robust global evidence base reflecting implementation and outcomes specific to low- and middle-income countries. This article presents a brief history of the Collaborative's work to date, proposes a common definition and key principles for group antenatal care, and recommends an evaluation and reporting framework for group antenatal care research.

Reducing Barriers That Hinder Obstetric Providers From Addressing Perinatal Depression: A Provider Education Module.

BACKGROUND: Perinatal depression affects approximately one in seven women and is one of the most common complications that occurs during pregnancy and the postpartum period. Untreated depression can have devastating consequences for the mother and her children. Despite the high prevalence and negative effects, pregnant and postpartum women face barriers to establishing adequate care and thus many go untreated. Many obstetric providers lack the understanding and confidence needed to manage and treat women who screen positive. OBJECTIVE: The purpose of this quality improvement project was to create and deliver an education program to obstetric providers on depression screening, assessment, and treatment. The objective was to increase knowledge and confidence levels needed to affect recognition and management of perinatal depression. METHODS: A PowerPoint presentation was utilized to educate providers on assessment and management of perinatal depression. A pre- and post-test design was used to evaluate the impact on knowledge and confidence levels. RESULTS: Mean scores on knowledge and confidence levels were increased following the PowerPoint presentation. CONCLUSION: This intervention appeared to have a positive impact on depression knowledge and confidence levels in obstetric providers. IMPLICATIONS FOR NURSING: This project is anticipated to promote early identification and intervention for perinatal depression.

Meconium aspiration syndrome: Incidence and outcomes using discharge data.

BACKGROUND: Meconium aspiration syndrome (MAS) is a leading cause of morbidity and mortality among term, otherwise healthy newborns, yet population studies are rare. Definitions, outcomes and International Classification of Diseases (ICD) codes are heterogenous, complicating estimates of incidence, outcomes and risks. AIMS: To measure population incidence, risks and outcomes of MAS by ICD codes. STUDY DESIGN: Retrospective population study. SUBJECTS: Kids Inpatient Database (KID) 2012, a nationally representative weighted sample of newborn discharges in the United States. OUTCOME MEASURES: Incidence, demographic distribution, and comorbidity associated with MAS. RESULTS: In 2012 there were 9295 weighted discharges diagnosed MAS with symptoms (2.49/1000) and 4304 cases without symptoms (1.15/1000). Newborns with symptoms had nearly twice the length of stay (LOS) (6.68 vs 3.65 days, p 0.001) and nearly 3 times the total charges ($44,473 versus $15,461, p < 0.001) as those without symptoms. Incidence of death was over four times higher (7.7/1000 vs 1.7/1000, p < 0.001), persistent pulmonary hypertension 3 times higher (57.6/1000 vs 15.8/1000, p < 0.001), and hypoxic ischemic encephalopathy 5 times higher (6.2/1000 vs 1.2/1000, p < 0.001) among MAS cases with respiratory symptoms than MAS cases without respiratory symptoms. Odds ratio of MAS with symptoms was 1.54 (95% CI 1.39-1.73) for black newborns compared to whites. CONCLUSIONS: Discharge data are useful for providing population estimates of MAS incidence. Prior studies have used consolidated ICD codes for MAS (with and without respiratory symptoms), yet these represent very different disease severities. Combining MAS diagnoses with and without respiratory symptoms misrepresents incidence and disease severity, complicating comparisons of outcomes and prevention strategies.

Implementation challenges and outcomes of a randomized controlled pilot study of a group prenatal care model in Malawi and Tanzania.

OBJECTIVE: To identify implementation challenges associated with conducting a randomized controlled trial (RCT) of group prenatal care (PNC) and report outcomes of the pilot. METHODS: A multi-site randomized pilot was conducted in Malawi and Tanzania between July 31, 2014, and June 30, 2015. Women aged at least 16 years with a pregnancy of 20-24 weeks were randomly assigned using sealed envelopes (1:1) to individual or group PNC. Structured interviews were conducted at baseline, in the third trimester and 6-8 weeks after delivery. The primary outcomes were attendance at four PNC visits and attendance at the 6-week postnatal visit. RESULTS: The pilot showed that an RCT with individual randomization can be conducted in these two low-resource settings. Significantly more women in group PNC than in individual PNC completed at least four PNC visits (96/102 [94.1%] vs 53/91 [58.2%]) and attended the postnatal visit (76/102 [74.5%] vs 45/90 [50.0%]; both P<0.001). CONCLUSION: Group PNC was feasible and associated with an increase in healthcare utilization and improved outcomes in Malawi and Tanzania. Lessons learned should be considered when designing large RCTs to determine efficacy. ClinicalTrials.gov: NCT02999334.

The Effect of a Clinical Practice Guideline for Acute Pelvic Pain on Length of Stay in the Emergency Department.

Length of stay (LOS) is a key measure of emergency department (ED) efficiency and a marker of overcrowding. The use of clinical practice guidelines (CPGs) has been shown to decrease the time spent in the ED. The objective of this study was to determine whether the utilization of a CPG for evaluation of acute pelvic pain in the ED would reduce patient LOS. This before-and-after study was conducted at a large urban Level II ED over the course of 2 years. A retrospective review of 134 electronic patient records: 67 charts prior to protocol implementation; 67 after implementation of a CPG for the evaluation of acute pelvic pain. Length of stay was based on the time from triage to discharge. The before-and-after protocol groups were compared using an independent-samples t test. Length of stay was actually increased in the protocol group (n = 67, M = 5:16, SD = 4:14 [hr:min]; p = 0.092). The use of diagnostic imaging was associated with longer LOS, varying with the specific imaging performed. Because of financial restructuring, the radiology unit reduced the availability of in-house sonography to 9:00 a.m.-5:00 p.m., Monday through Friday, which also possibly affected the LOS. Of significance was the willingness of the health care providers to utilize the CPG (86%). Time of day, availability of in-house ultrasound, and individual provider judgment influence ED LOS and subsequent imaging performed. Future research is necessary to determine how these and other factors can be incorporated into a model for predicting LOS, reducing provider disparities, and ensuring patient safety.

Group prenatal care and preterm birth weight: results from a matched cohort study at public clinics.

OBJECTIVE: To examine the impact of group versus individual prenatal care on birth weight and gestational age. METHODS: This prospective, matched cohort study included pregnant women (N = 458) entering prenatal care at 24 or less weeks' gestation; one half received group prenatal care with women of the same gestational age. Women were matched by clinic, age, race, parity, and infant birth date. Women were predominantly black and Hispanic of low socioeconomic status, served by one of three public clinics in Atlanta, Georgia or New Haven, Connecticut. RESULTS: Birth weight was greater for infants of women in group versus individual prenatal care (P < .01). Among those born preterm, infants of group patients were significantly larger than infants of individual-care patients (mean, 2398 versus 1990 g, P < .05). Although not statistically significant, infants of group patients were less likely than those of individual-care patients to be low birth weight (less than 2500 g; 16 versus 23 infants); very low birth weight (less than 1500 g; three versus six infants); early preterm (less than 33 weeks; two versus seven infants); or to experience neonatal loss (none versus three infants). There were no differences in number of prenatal visits or other risk characteristics (patient age, race, prior preterm birth). CONCLUSIONS: Group prenatal care results in higher birth weight, especially for infants delivered preterm. Group prenatal care provides a structural innovation, permitting more time for provider-patient interaction and therefore the opportunity to address clinical as well as psychological, social, and behavioral factors to promote healthy pregnancy. Results have implications for design of sustainable prenatal services that might contribute to reduction of racial disparities in adverse perinatal outcomes.

Centering pregnancy: a model for pregnant adolescents.

Recent exploration of the experiences of pregnant and parenting adolescents has uncovered the need to address the unique developmental, social, and cultural aspects of adolescent pregnancy. Many adolescents, especially those from urban areas, live in communities with limited opportunities, poverty, violence, and a lack of support. Programs that help young women discover their inner strength, create environments for empowerment, and build community may help adolescents to achieve goals and parent successfully. Centering Pregnancy is a model of group prenatal care that provides for the assessment, education, and support of pregnant women and may be particularly useful in adolescent populations. The model is described and the ways adolescents may benefit from Centering Pregnancy's unique design is discussed.

Adolescent emergency contraception: attitudes and practices of certified nurse-midwives.

Teenage pregnancy has reached epidemic proportions in the United States with I million pregnancies and more than 500,000 live births occurring each year among women under the age of 20. The safety and efficacy of postcoital administration of oral contraceptives, commonly called "emergency contraception" (EC), have been well documented. However, EC is dramatically underused in the United States. Because low use of EC may be attributable, in part, to both lack of knowledge, as well as misinformation on the part of health care providers, further research in this area is warranted. Because midwives play a significant role in the provision of reproductive health care to adolescents, their attitudes about the use of EC among teens may impact the availability of emergency contraception options to these clients. This article presents results of a survey of certified nurse-midwives with respect to their attitudes, practices, and policies related to EC and provides recommendations specific to this provider population.

Redesigning prenatal care through CenteringPregnancy.

CenteringPregnancy is a model of group prenatal care that provides more than 20 hours of contact time between the childbearing care provider and a cohort of pregnant women with similar due dates. During this time, each woman has the opportunity to build community with other pregnant women, learn self-care skills, get assurance about the progression of her pregnancy, and gain knowledge about pregnancy, birth, and parenting. Ten essential elements have been defined, which contribute to the success of this model of prenatal care delivery. These elements correspond with the Institute of Medicine's 2001 challenge to improve the quality of health care in the United States. Foundational perspectives provide potential explanations for the model's growing influence and success. Implications for clinical practice and further research to link it with perinatal health outcomes are suggested.

CenteringPregnancy-Africa: a pilot of group antenatal care to address Millennium Development Goals.

BACKGROUND: severe health worker shortages and resource limitations negatively affect quality of antenatal care (ANC) throughout sub-Saharan Africa. Group ANC, specifically CenteringPregnancy (CP), may offer an innovative approach to enable midwives to offer higher quality ANC. OBJECTIVE: our overarching goal was to prepare to conduct a clinical trial of CenteringPregnancy-Africa (CP-Africa) in Malawi and Tanzania. In Phase 1, our goal was to determine the acceptability of CP as a model for ANC in both countries. In Phase 2, our objective was to develop CP-Africa session content consistent with the Essential Elements of CP model and with national standards in both Malawi and Tanzania. In Phase 3, our objective was to pilot CP-Africa in Malawi to determine whether sessions could be conducted with fidelity to the Centering process. SETTING: Phases 1 and 2 took place in Malawi and Tanzania. Phase 3, the piloting of two sessions of CP-Africa, occurred at two sites in Malawi: a district hospital and a small clinic. DESIGN: we used an Action Research approach to promote partnerships among university researchers, the Centering Healthcare Institute, health care administrators, health professionals and women attending ANC to develop CP-Africa session content and pilot this model of group ANC. PARTICIPANTS: for Phases 1 and 2, members of the Ministries of Health, health professionals and pregnant women in Malawi and Tanzania were introduced to and interviewed about CP. In Phase 2, we finalised CP-Africa content and trained 13 health professionals in the Centering Healthcare model. In Phase 3, we conducted a small pilot with 24 pregnant women (12 at each site). MEASUREMENTS AND FINDINGS: participants enthusiastically embraced CP-Africa as an acceptable model of ANC health care delivery. The CP-Africa content met both CP and national standards. The pilot established that the CP model could be implemented with process fidelity to the 13 Essential Elements. Several implementation challenges and strategies to address these challenges were identified. KEY CONCLUSIONS: preliminary data suggest that CP-Africa is feasible in resource-constrained, low-literacy, high-HIV settings in sub-Saharan Africa. By improving the quality of ANC delivery, midwives have an opportunity to make a contribution towards Millennium Development Goals (MDG) targeting improvements in child, maternal and HIV-related health outcomes (MDGs 4, 5 and 6). A clinical trial is needed to establish efficacy. IMPLICATIONS FOR PRACTICE: CP-Africa also has the potential to reduce job-related stress and enhance job satisfaction for midwives in low income countries. If CP can be transferred with fidelity to process in sub-Saharan Africa and retain similar results to those reported in clinical trials, it has the potential to benefit pregnant women and their infants and could make a positive contribution to MGDs 4, 5 and 6.

Perinatal grief in Latino parents.

Extensive research exists that describes the meaning of perinatal loss to some parents, but the experience of loss from the perspective of Latino parents is not clearly understood. Additionally, current perinatal bereavement practices used often to facilitate memory making for parents (such as viewing or holding the baby, taking photographs, or collecting mementos) are based on research done primarily with non-Latino families. Are these common practices appropriate for this population? Because there is a paucity of research on this topic, this article describes what has been written over the past 30 years on the topic of grief and perinatal loss in Latino culture.

Introduction of CenteringPregnancy in a public health clinic.

CenteringPregnancy is a promising group visit prenatal care innovation that provides substantial health promotion content. Elements unique to group care include peer support and self-management training and activities. CenteringPregnancy was introduced at a large public health clinic serving predominantly low-income African American pregnant women. All prenatal care at this clinic was provided by certified nurse-midwives, and all providers were trained in the CenteringPregnancy model. One hundred and ten women received prenatal care in CenteringPregnancy groups. Focus groups of pregnant women, providers, and health center staff reported that the program benefited women despite implementation challenges such as scheduling changes. Compared to women in individual care, women in CenteringPregnancy had significantly more prenatal visits, increased weight gain, increased breast feeding rates, and higher overall satisfaction. This pilot project demonstrated that CenteringPregnancy can be implemented in a busy public health clinic serving predominantly low-income pregnant women and is associated with positive health outcomes.