Dataset Information

Group versus individual antenatal and first year postpartum care: Study protocol for a multi-country cluster randomized controlled trial in Kenya and Nigeria.

ABSTRACT: Background: Antenatal care (ANC) in many low- and middle-income countries is under-utilized and of sub-optimal quality. Group ANC (G-ANC) is an intervention designed to improve the experience and provision of ANC for groups of women (cohorts) at similar stages of pregnancy. Methods: A two-arm, two-phase, cluster randomized controlled trial (cRCT) (non-blinded) is being conducted in Kenya and Nigeria. Public health facilities were matched and randomized to either standard individual ANC (control) or G-ANC (intervention) prior to enrollment. Participants include pregnant women attending first ANC at gestational age <24 weeks, health care providers, and sub-national health managers. Enrollment ended in June 2017 for both countries. In the intervention arm, pregnant women are assigned to cohorts at first ANC visit and receive subsequent care together during five meetings facilitated by a health care provider (Phase 1). After birth, the same cohorts meet four times over 12 months with their babies (Phase 2). Data collection was performed through surveys, clinical data extraction, focus group discussions, and in-depth interviews. Phase 1 data collection ended in January 2018 and Phase 2 concludes in November 2018. Intention-to-treat analysis will be used to evaluate primary outcomes for Phases 1 and 2: health facility delivery and use of a modern method of family planning at 12 months postpartum, respectively. Data analysis and reporting of results will be consistent with norms for cRCTs. General estimating equation models that account for clustering will be employed for primary outcome analyzes. Results: Overall 1,075 and 1,013 pregnant women were enrolled in Nigeria and Kenya, respectively. Final study results will be available in February 2019. Conclusions: This is the first cRCT on G-ANC in Africa. It is among the first to examine the effects of continuing group care through the first year postpartum. Registration: Pan African Clinical Trials Registry PACTR201706002254227 May 02, 2017.

SUBMITTER: Kabue MM

PROVIDER: S-EPMC6350506 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Group versus individual antenatal and first year postpartum care: Study protocol for a multi-country cluster randomized controlled trial in Kenya and Nigeria.

Kabue Mark M MM Grenier Lindsay L Suhowatsky Stephanie S Oyetunji Jaiyeola J Ugwa Emmanuel E Onguti Brenda B Omanga Eunice E Gichangi Anthony A Wambua Jonesmus J Waka Charles C Enne Joseph J Don-Aki Jennyfer J Ali Mairo M Buba Maryam M Ang'aha Jenipher J Iya Daniel D Washika Elizabeth E Mohan Diwakar D Smith Jeffrey M JM

Gates open research 20180101

<b>Background:</b> Antenatal care (ANC) in many low- and middle-income countries is under-utilized and of sub-optimal quality. Group ANC (G-ANC) is an intervention designed to improve the experience and provision of ANC for groups of women (cohorts) at similar stages of pregnancy. <b>Methods:</b> A two-arm, two-phase, cluster randomized controlled trial (cRCT) (non-blinded) is being conducted in Kenya and Nigeria. Public health facilities were matched and randomized to either standard individual ...[more]

PMID: 30706056

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Project description:BACKGROUND:Low quality and frequency of antenatal care (ANC) are associated with lower uptake of facility-based deliveries-a key intervention to reduce maternal and neonatal mortality. We implemented group ANC (G-ANC), an alternative service delivery model, in Kenya and Nigeria, to assess its impact on quality and attendance at ANC and uptake of facility-based delivery. METHODS:From October 2016‒January 2018, we conducted a facility-based, pragmatic, cluster-randomized controlled trial with 20 clusters per country. We recruited women <24 weeks gestation during their first ANC visit and enrolled women at intervention facilities who agreed to attend G-ANC in lieu of routine individual ANC. The G-ANC model consisted of five monthly 2-hour meetings with clinical assessments alongside structured gestationally specific group discussions and activities. Quality of care was defined as receipt of eight specific ANC interventions. Data were obtained through facility records and self-report during a home-based postpartum survey. Analysis was by intention to treat. FINDINGS:All women who completed follow up are included in the analysis (Nigeria: 1018/1075 enrolled women [94.7%], Kenya: 826/1013 [81.5%]). In Nigeria women in the intervention arm were more likely to have a facility-based delivery compared to those in the control arm (Nigeria: 76.7% [391/510] versus 54.1% [275/508]; aOR 2.30, CI 1.51-3.49). In both countries women in the intervention arm were more likely than those in the control arm to receive quality ANC (Nigeria: aOR 5.8, CI 1.98-17.21, p<0.001; Kenya: aOR 5.08, CI 2.31-11.16, p<0.001) and to attend at least four ANC visits (Nigeria: aOR 13.30, CI 7.69-22.99, p<0.001; Kenya: aOR 7.12, CI 3.91-12.97, p<0.001). CONCLUSIONS:G-ANC was associated with higher facility-based delivery rates in Nigeria, where those rates associated with individual ANC were low. In both Kenya and Nigeria it was associated with a higher proportion of women receiving quality ANC and higher frequency of ANC visits.

Project description:BackgroundGroup antenatal care (G-ANC) is a promising model for improving quality of maternal care and outcomes in low- and middle-income countries (LMICs) but little has been published examining the mechanisms by which it may contribute to those improvements. Substantial interplay can be expected between pregnant women and providers' respective experiences of care, but most studies report findings separately. This study explores the experience and effects of G-ANC on both women and providers to inform an integrated theory of change for G-ANC in LMICs.MethodsThis paper reports on multiple secondary outcomes from a pragmatic cluster randomized controlled trial of group antenatal care in Kenya and Nigeria conducted from October 2016-November 2018 including 20 clusters per country. We collected qualitative data from providers and women providing or receiving group antenatal care via focus group discussions (19 with women; 4 with providers) and semi-structured interviews (42 with women; 4 with providers). Quantitative data were collected via surveys administered to 1) providers in the intervention arm at enrollment and after facilitating 4 cohorts and 2) women in both study arms at enrollment; 3-6 weeks postpartum; and 1 year postpartum. Through an iterative approach with framework analysis, we explored the interactions of voiced experience and perceived effects of care and placed them relationally within a theory of change. Selected variables from baseline and final surveys were analyzed to examine applicability of the theory to all study participants.ResultsFindings support seven inter-related themes. Three themes relate to the shared experience of care of women and providers: forming supportive relationships and open communication; becoming empowered partners in learning and care; and providing and receiving meaningful clinical services and information. Four themes relate to effects of that experience, which are not universally shared: self-reinforcing cycles of more and better care; linked improvements in health knowledge, confidence, and healthy behaviors; improved communication, support, and care beyond G-ANC meetings; and motivation to continue providing G-ANC. Together these themes map to a theory of change which centers the shared experience of care for women and providers among multiple pathways to improved outcomes.DiscussionThe reported experience and effects of G-ANC on women and providers are consistent with other studies in LMICs. This study is novel because it uses the themes to present a theory of change for G-ANC in low-resource settings. It is useful for G-ANC implementation to inform model development, test adaptations, and continue exploring mechanisms of action in future research.

Project description:We tested the hypotheses that mothers of infants who exclusively breastfed would differ in the trajectories of postpartum BMI changes than mothers of infants who exclusively formula fed, but such benefits would differ based on the maternal BMI status prepregnancy (primary hypothesis) and that psychological eating behavior traits would have independent effects on postpartum BMI changes (secondary hypothesis). To these aims, linear mixed-effects models analyzed measured anthropometric data collected monthly from 0.5 month (baseline) to 1 year postpartum from two groups of mothers distinct in infant feeding modality (Lactating vs. Non-lactating). While infant feeding modality group and prepregnancy BMI status had independent effects on postpartum BMI changes, the benefits of lactation on BMI changes differed based on prepregnancy BMI. When compared to lactating women, initial rates of BMI loss were significantly slower in the non-lactating women who were with Prepregnancy Healthy Weight (β = 0.63 percent BMI change, 95% CI: 0.19, 1.06) and with Prepregnancy Overweight (β = 2.10 percent BMI change, 95% CI: 1.16, 3.03); the difference was only a trend for those in the Prepregnancy Obesity group (β = 0.60 percent BMI change, 95% CI: -0.03, 1.23). For those with Prepregnancy Overweight, a greater percentage of non-lactating mothers (47%) gained ≥ 3 BMI units by 1 year postpartum than did lactating mothers (9%; p < 0.04). Psychological eating behavior traits of higher dietary restraint, higher disinhibition, and lower susceptibility to hunger were associated with greater BMI loss. In conclusion, while there are myriad advantages to lactation, including greater initial rates of postpartum weight loss regardless of prepregnancy BMI, mothers who were with overweight prior to the pregnancy experienced substantially greater loss if they breastfed their infants. Individual differences in psychological eating behavior traits hold promise as modifiable targets for postpartum weight management.

Project description:BackgroundPostpartum haemorrhage (PPH) is the leading cause of global maternal deaths, accounting for 30-50% of maternal deaths in sub-Saharan Africa. Most PPH-related deaths are preventable with timely detection and initiation of care, which may be facilitated by using a clinical care bundle. We explore influences on current PPH detection and management and on the future implementation of a new PPH bundle (E-MOTIVE) in low-resource, high-burden settings.MethodsSemi-structured qualitative interviews based on the Theoretical Domains Framework were conducted with 45 healthcare providers across nine hospitals in Nigeria, Kenya and South Africa, to identify barriers and enablers to current PPH detection and management and future implementation of a new PPH care bundle. Data were analysed using thematic and framework analysis. The Behaviour Change Wheel was used to identify potential interventions to address identified barriers and enablers.ResultsInfluences on current PPH detection and management fell under 12 domains: Environmental Context and Resources (drug and staff shortages), Skills (limited in-service training), Knowledge (variable understanding of the recommended practice), Behaviour Regulation (limited quality improvement culture), Beliefs about Consequences (drawbacks from inaccurate detection), Emotion (stress from the unpredictability of PPH), Social Influence (teamwork), Memory, Attention and Decision-making (limited guideline use), Social/Professional Role and Identity (role clarity), Beliefs about Capabilities (confidence in managing PPH), Reinforcement (disciplinary procedures) and Goals (PPH as a priority). Influences on bundle uptake included: Beliefs about Consequences (perceived benefits of new blood loss measurement tool), Environmental Context and Resources (high cost of drugs and new tools), Memory, Attention and Decision-making (concerns about whether bundle fits current practice), Knowledge (not understanding 'bundled' approach), Social Influence (acceptance by women and staff) and Intention (limited acceptance of 'bundled' approach over existing practice). These influences were consistent across countries. Proposed interventions included: Education, Training, Modelling (core and new skills), Enablement (monitoring uptake), Persuasion (leadership role) and Environmental Restructuring (PPH emergency trolley/kit).ConclusionsA wide range of individual, socio-cultural and environmental barriers and enablers to improving PPH detection and management exist in these settings. We identified a range of interventions that could improve PPH care and the implementation of new care bundles in this context.Trial registrationClinicalTrials.gov : NCT04341662.

Project description:BackgroundMaternal weight variables are important predictors of postpartum depression (PPD). While preliminary evidence points to an association between pre-pregnancy obesity and PPD, the role of excessive gestational weight gain (GWG) on PPD is less studied. In this secondary cohort analysis of the German 'healthy living in pregnancy' (GeliS) trial, we aimed to investigate associations between weight-related variables and PPD and to assess the influence of GWG on the risk for PPD.MethodsWe included women with normal weight, overweight, and obesity (BMI 18.5-40.0 kg/m2). Symptoms of PPD were assessed 6-8 weeks postpartum using the Edinburgh Postnatal Depression Scale. Pre-pregnancy BMI was self-reported. During the course of pregnancy, weight was measured at gynaecological practices within regular check-ups. GWG was defined as the difference between the last measured weight before delivery and the first measured weight at the time of recruitment (≤ 12th week of gestation). Excessive GWG was classified according to the Institute of Medicine. Multiple logistic regression analyses were used to estimate the odds of PPD in relation to pre-pregnancy BMI, GWG, and excessive GWG adjusting for important confounders.ResultsOf the total 1583 participants, 45.6% (n = 722) showed excessive GWG and 7.9% (n = 138) experienced PPD. Pre-pregnancy BMI (per 5-unit increase; OR = 1.23, 95% CI 1.08-1.41, p = 0.002) and pre-pregnancy overweight or obesity were significantly positively associated with the odds of developing PPD, particularly among women with an antenatal history of anxiety or depressive symptoms (overweight: OR = 1.93, 95% CI = 1.15-3.22, p = 0.01; obesity: OR = 2.11, 95% CI = 1.13-3.96, p = 0.02). Sociodemographic or lifestyle factors did not additively influence the odds of having PPD. In fully adjusted models, there was no significant evidence that GWG or the occurrence of excessive GWG increased the odds of experiencing PPD (excessive vs. non-excessive: OR = 3.48, 95% CI 0.35-34.94; GWG per 1 kg increase: OR = 1.16, 95% CI 0.94-1.44).ConclusionPre-pregnancy overweight or obesity is associated with PPD independent of concurrent risk factors. History of anxiety or depressive symptoms suggests a stress-induced link between pre-pregnancy weight and PPD.Trial registrationNCT01958307 , ClinicalTrials.gov, retrospectively registered on 9 October 2013.

Dataset Information

Group versus individual antenatal and first year postpartum care: Study protocol for a multi-country cluster randomized controlled trial in Kenya and Nigeria.

Publications

Group versus individual antenatal and first year postpartum care: Study protocol for a multi-country cluster randomized controlled trial in Kenya and Nigeria.

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