High rates of adverse pregnancy outcomes globally raise the need to understand risk factors and develop preventative interventions. The Pregnancy Outcomes in the Era of Universal Antiretroviral ...Treatment in Sub-Saharan Africa (POISE Study) was a prospective, observational cohort study conducted from 2016 to 2017 in Blantyre, Malawi. We examine the associations between indicators of nutritional status, specifically mid-thigh circumference (MTC) and body-mass index (BMI), and adverse pregnancy outcomes, low birth weight (LBW), preterm birth (PTB), and small-for-gestational age (SGA), in a cohort of HIV-infected and HIV-uninfected women.
Sociodemographic, clinical, laboratory, and maternal height, weight and MTC data were collected immediately before or after delivery at the Queen Elizabeth Central Hospital (QEHC) and 4 affiliated health centers in Blantyre, Malawi. LBW was defined as birth weight < 2.5 kg; PTB as gestational age < 37 weeks using Ballard score; and SGA as birth weight < 10th percentile for gestational age. Descriptive, stratified, and multivariable logistic regression were conducted using R.
Data from 1298 women were analyzed: 614 HIV-infected and 684 HIV-uninfected. MTC was inversely associated with LBW (adjusted odds ratio aOR = 0.95, p = 0.03) and PTB (aOR 0.92, p < 0.001), after controlling for HIV status, age, socioeconomic status and hemoglobin. The association between MTC and SGA was (aOR 0.99, p = 0.53). Similarly, higher BMI was significantly associated with lower odds of PTB (aOR 0.90, p < 0.001), LBW (aOR 0.93, p = 0.05), and SGA (aOR 0.95, p = 0.04).
We observed an inverse relationship between MTC and adverse pregnancy outcomes in Malawi irrespective of HIV infection. MTC performs comparably to BMI; the ease of measuring MTC could make it a practical tool in resource-constrained settings for identification of women at risk of adverse pregnancy outcomes.
HIV counseling and testing for couples is an important component of HIV prevention strategies, particularly in Sub Saharan Africa. The purpose of this pilot study is to estimate the uptake of couple ...HIV counseling and testing (CHCT) and couple family planning (CFP) services in a single home visit in peri-urban Malawi and to assess related factors.
This study involved offering CHCT and CFP services to couples in their homes; 180 couples were sampled from households in a peri-urban area of Blantyre. Baseline data were collected from both partners and follow-up data were collected one week later. A pair of male and female counselors approached each partner separately about HIV testing and counseling and contraceptive services and then, if both consented, CHCT and CFP services (pills, condoms and referrals for other methods) were given. Bivariate and multivariate logistic regression analyses were done to examine the relationship between individual partner characteristics and acceptance of the services. Selected behaviors reported pre- and post-intervention, particularly couple reports on contraceptive use and condom use at last sex, were also tested for differences.
89% of couples accepted at least one of the services (58% CHCT-only, 29% CHCT + CFP, 2% CFP-only). Among women, prior testing experience (p < 0.05), parity (p < 0.01), and emotional closeness to partner (p < 0.01) had significant bivariate associations with acceptance of at least one service. Reported condom use at last sex increased from 6% to 25% among couples receiving any intervention. First-ever HIV testing was delivered to 25 women and 69 men, resulting, respectively, in 4 and 11 newly detected infections.
Home-based CHCT and CFP were very successful in this pilot study with high proportions of previously untested husbands and wives accepting CHCT and there were virtually no negative outcomes within one week. This study supports the need for further research and testing of home- and couple-based approaches to expand access to HCT and contraceptive services to prevent the undesired consequences of sexually transmitted infection and unintended pregnancy via unprotected sex.
Female‐initiated HIV prevention methods, such as oral pre‐exposure prophylaxis (PrEP) and the vaginal ring, may be important risk reduction strategies for breastfeeding women. Given their novelty, ...information about the sociocultural context and how it influences perceptions of and support for their use during breastfeeding is lacking. To address this gap, we conducted 23 focus group discussions separately with pregnant and breastfeeding women, male partners and grandmothers (N = 196) and 36 in‐depth interviews with key informants in Malawi, South Africa, Uganda and Zimbabwe. We analysed the data using a framework analysis method. Overall, breastfeeding was the norm, and participants described the transference of health (e.g., nutrition) and disease (e.g., HIV) to children through breast milk. Participants considered the early breastfeeding period as one of high HIV transmission risk for women. They explained that male partners tend to seek outside sexual partners during this period because women need time to recover from delivery, women focus their attention on the child, and some men are disgusted by breast milk. Participants highlighted concerns about the drugs in oral PrEP transferring to the child through breast milk, but fewer worried about the effects of the vaginal ring because the drug is localized. Women, grandmothers and key informants were supportive of women using these HIV prevention methods during breastfeeding, while male partners had mixed opinions. These findings can be used to tailor messages for promoting the use of PrEP or the vaginal ring during breastfeeding in sub‐Saharan Africa.
Reducing preterm birth and stillbirth and improving outcomes for babies born too soon is essential to reduce under-5 mortality globally. In the context of a rapidly evolving evidence base and ...problems with extrapolating efficacy data from high- to low-income settings, an assessment of the evidence for maternal and newborn interventions specific to low- and middle-income countries (LMICs) is required.
A systematic review of the literature was done. We included all studies performed in LMICs since the Every Newborn Action Plan, between 2013 - 2018, which reported on interventions where the outcome assessed was reduction in preterm birth or stillbirth incidence and/or a reduction in preterm infant neonatal mortality. Evidence was categorised according to maternal or neonatal intervention groups and a narrative synthesis conducted.
179 studies (147 primary evidence studies and 32 systematic reviews) were identified in 82 LMICs. 81 studies reported on maternal interventions and 98 reported on neonatal interventions. Interventions in pregnant mothers which resulted in significant reductions in preterm birth and stillbirth were (i) multiple micronutrient supplementation and (ii) enhanced quality of antenatal care. Routine antenatal ultrasound in LMICs increased identification of fetal antenatal conditions but did not reduce stillbirth or preterm birth due to the absence of services to manage these diagnoses. Interventions in pre-term neonates which improved their survival included (i) feeding support including probiotics and (ii) thermal regulation. Improved provision of neonatal resuscitation did not improve pre-term mortality rates, highlighting the importance of post-resuscitation care. Community mobilisation, for example through community education packages, was found to be an effective way of delivering interventions.
Evidence supports the implementation of several low-cost interventions with the potential to deliver reductions in preterm birth and stillbirth and improve outcomes for preterm babies in LMICs. These, however, must be complemented by overall health systems strengthening to be effective. Quality improvement methodology and learning health systems approaches can provide important means of understanding and tackling implementation challenges within local contexts. Further pragmatic efficacy trials of interventions in LMICs are essential, particularly for interventions not previously tested in these contexts.
To investigate a method of using patient-held records to collect contraception data in Malawi, that could be used to explore contraceptive discontinuation and method switching.
In 2012, all 7393 ...women aged 15 to 49 years living in the area covered by the Karonga demographic surveillance site were offered a family planning card, which was attached to the woman's health passport - a patient-held medical record. Health-care providers were trained to use the cards to record details of contraception given to women. During the study, providers underwent refresher training sessions and received motivational text messages to improve data completeness. After one year, the family planning cards were collected for analysis.
Of the 7393 eligible women, 6861 (92.8%) received a family planning card and 4678 (63.3%) returned it after one year. Details of 87.3% (2725/3122) of contacts between health-care providers and the women had been recorded by health-care providers on either family planning cards or health passports. Lower-level health-care providers were more diligent at recording data on the family planning cards than higher-level providers.
The use of family planning cards was an effective way of recording details of contraception provided by family planning providers. The involvement of health-care providers was key to the success of this approach. Data collected in this way should prove helpful in producing accurate estimates of method switching and the continuity of contraceptive use by women.
The estimated annual global burden of miscarriage is 33 million out of 210 million pregnancies. Many women undergoing miscarriage have surgery to remove pregnancy tissues, resulting in miscarriage ...surgery being one of the most common operations performed in hospitals in low-income countries. Infection is a serious consequence and can result in serious illness and death. In low-income settings, the infection rate following miscarriage surgery has been reported to be high. Good quality evidence on the use of prophylactic antibiotics for surgical miscarriage management is not available. Given that miscarriage surgery is common, and infective complications are frequent and serious, prophylactic antibiotics may offer a simple and affordable intervention to improve outcomes.
Eligible patients will be approached once the diagnosis of miscarriage has been made according to local practice. Once informed consent has been given, participants will be randomly allocated using a secure internet facility (1:1 ratio) to a single dose of oral doxycycline (400 mg) and metronidazole (400 mg) or placebo. Allocation will be concealed to both the patient and the healthcare providers. A total of 3400 women will be randomised, 1700 in each arm. The medication will be given approximately 2 hours before surgery, which will be provided according to local practice. The primary outcome is pelvic infection 2 weeks after surgery. Women will be invited to the hospital for a clinical assessment at 2 weeks. Secondary outcomes include overall antibiotic use, individual components of the primary outcome, death, hospital admission, unplanned consultations, blood transfusion, vomiting, diarrhoea, adverse events, anaphylaxis and allergy, duration of clinical symptoms, and days before return to usual activities. An economic evaluation will be performed to determine if prophylactic antibiotics are cost-effective.
This trial will assess whether a single dose of doxycycline (400 mg) and metronidazole (400 mg) taken orally 2 hours before miscarriage surgery can reduce the incidence of pelvic infection in women up to 2 weeks after miscarriage surgery.
Registered with the ISRCTN (international standard randomised controlled trial number) registry: ISRCTN 97143849 . (Registered on April 17, 2013).
Frequency of sex, contraceptive use and HIV infection are key determinants of fertility. Use of an effective family planning (EFP) method (injectable, oral, intra-uterine contraceptive device (IUCD), ...or Norplant) potentially eliminates women's concerns of unintended pregnancy. We report the association between EFP and frequency of sex among HIV-infected and HIV-uninfected non-pregnant African women.
Prospective fertility intentions study nested within a phase 3 randomized double-masked placebo-controlled trial (2003-2005) to treat genital tract infections in HIV-infected and HIV-uninfected non-pregnant women. Enrollment of study participants was stratified by HIV infection status. Data on demographics, family planning and sexual history were obtained at baseline and at 3, 6, 9 and 12 months. Chi square and Wilcoxon Rank-Sum tests were used to compare categorical and continuous variables, respectively. Generalized Estimating Equations method was used to estimate relative risk (RR) of frequent sex (≥ 2 acts/week) among users of different EFP methods (injectable, oral, implant or intra-uterine contraceptive device).
After adjusting for age, current health status, and fertility intentions, EFP use was significantly associated with frequent sex among HIV-infected women (RR 1.32; 95% Confidence Interval CI 1.14-1.52); this association was not statistically significant among HIV-uninfected women (RR 1.10; 95% CI 0.96-1.24). Fertility intentions among HIV-infected, and education among HIV-uninfected womenwere independent predictors of sex frequency.
These data suggest that the association between EFP use and frequency of sex among women varies by HIV infection status. Service-delivery of diverse EFP methods should be integrated within HIV counseling, testing and treatment facilities.
Registration number NCT00140764 under the clinicaltrials.gov, first Posted: September 1, 2005, last Update Posted: August 10, 2011.
Intracellular tenofovir diphosphate (TFV-DP) concentration in dried blood spots (DBSs) is used to monitor cumulative pre-exposure prophylaxis (PrEP) adherence. We evaluated TFV-DP in DBSs following ...daily oral PrEP (emtricitabine 200 mg/tenofovir diphosphate 300 mg) among pregnant and postpartum adolescent girls and young women (AGYW).
Directly observed PrEP was administered for 12 weeks in a pregnancy (14-24 weeks' gestation, n = 20) and postpartum (6-12 weeks postpartum, n = 20) group of AGYW aged 16-24 years in sub-Saharan Africa. Weekly DBS TFV-DP was measured by validated liquid chromatography-tandem mass spectrometry assay. Week 12 TFV-DP distributions were compared between groups with Wilcoxon test. Population pharmacokinetic models were fit to estimate steady-state concentrations and create benchmarks for adherence categories. Baseline correlates of TFV-DP were evaluated.
Median age was 20 (IQR, 19-22) years. Of 3360 doses, 3352 (>99%) were directly observed. TFV-DP median (IQR) half-life was 10 (7-12) days in pregnancy and 17 (14-21) days postpartum, with steady state achieved by 5 and 8 weeks, respectively. Observed median (IQR) steady-state TFV-DP was 965 fmol/punch (691-1166) in pregnancy versus 1406 fmol/punch (1053-1859) postpartum (P = .006). Modeled median steady-state TFV-DP was 881 fmol/punch (667-1105) in pregnancy versus 1438 fmol/punch (1178-1919) postpartum. In pooled analysis, baseline creatinine clearance was associated with observed TFV-DP concentrations.
TFV-DP in African AGYW was approximately one-third lower in pregnancy than postpartum. These Population-specific benchmarks can be used to guide PrEP adherence support in pregnant/postpartum African women.
NCT03386578.
Mental health is a significant contributor to global burden of disease and the consequences of perinatal psychiatric morbidity can be substantial. We aimed to obtain global estimates of puerperal ...psychosis prevalence based on population-based samples and to understand how postpartum psychosis is assessed and captured among included studies.
In June 2014, we searched PubMed, CiNAHL, EMBASE, PsycINFO, Sociological Collections, and Global Index Medicus for publications since the year 1990. Criteria for inclusion in the systematic review were: use of primary data relevant to pre-defined mental health conditions, specified dates of data collection, limited to data from 1990 onwards, sample size >200 and a clear description of methodology. Data were extracted from published peer reviewed articles.
The search yielded 24,273 publications, of which six studies met the criteria. Five studies reported incidence of puerperal psychosis (ranging from 0.89 to 2.6 in 1000 women) and one reported prevalence of psychosis (5 in 1000). Due to the heterogeneity of methodologies used across studies in definitions and assessments used to identify cases, data was not pooled to calculate a global estimate of risk.
This review confirms the relatively low rate of puerperal psychosis; yet given the potential for serious consequences, this morbidity is significant from a global public health perspective. Further attention to consistent detection of puerperal psychosis can help provide appropriate treatment to prevent harmful consequences for both mother and baby.
Malawi faces a severe shortage of health workers, a factor that has contributed greatly to high maternal mortality in the country. Most clinical care is performed by mid-level providers (MLPs). While ...utilization of these cadres in providing health care is a solution to the current shortages, demotivating factors within the Malawian health system are pushing them into private, non-governmental, and other non-health related positions. This study aims to highlight these demotivating factors by exploring the critical aspects that influence MLPs' intention to leave their jobs.
This descriptive qualitative study formed part of the larger Health Systems Strengthening for Equity (HSSE) study. Data presented in this paper were collected in Malawi using the Critical Incident Analysis tool. Participants were asked to narrate an incident that had happened during the past three months which had made them seriously consider leaving their job. Data were subjected to thematic analysis using NVivo 8 software.
Of the 84 respondents who participated in a Critical Incident Analysis interview, 58 respondents (69%) indicated they had experienced a demotivating incident in the previous three months that had made them seriously consider leaving their job. The most commonly cited critical factors were being treated unfairly or with disrespect, lack of recognition of their efforts, delays and inconsistencies in salary payments, lack of transparent processes and criteria for upgrading or promotion, and death of patients.
Staff motivation and an enabling environment are crucial factors for retaining MLPs in the Malawian health system. This study revealed key 'tipping points' that drive staff to seriously consider leaving their jobs. Many of the factors underlying these critical incidents can be addressed by improved management practices and the introduction of fair and transparent policies. Managers need to be trained and equipped with effective managerial skills and staff should have access to equal opportunities for upgrading and promotion. There is need for continuous effort to mobilize the resources needed to fill gaps in basic equipment, supplies, and medicine, as these are critical in creating an enabling environment for MLPs.