Iron-deficiency anemia is a known risk factor for several adverse perinatal outcomes, but data on its impact on specific maternal morbidities is less robust. Further, information on associations ...between anemia in early pregnancy and subsequent outcomes are understudied.
The study population was derived from the Community Level Interventions for Pre-eclampsia (CLIP) trial in Karnataka State, India (NCT01911494). Included were women who were enrolled in either trial arm, delivered by trial end date, and had a baseline measure of hemoglobin (Hb). Anemia was classified by WHO standards into four groups: none (Hb ≥ 11 g/dL), mild (10.0 g/dL ≤ Hb < 11.0 g/dL), moderate (7.0 g/dL ≤ Hb < 10.0 g/dL) and severe (Hb < 7.0 g/dL). Targeted maximum likelihood estimation was used to estimate confounder-adjusted associations between anemia and a composite (and its components) of adverse maternal outcomes, including pregnancy hypertension. E-values were calculated to assess robustness to unmeasured confounding.
Of 11,370 women included, 10,066 (88.5%) had anemia, that was mild (3690, 32.5%), moderate (6023, 53.0%), or severe (68, 0.6%). Almost all women (> 99%) reported taking iron supplements during pregnancy. Blood transfusions was more often administered to those with anemia that was mild (risk ratio RR 2.16, 95% confidence interval CI 1.31-3.56), moderate (RR 2.37, 95% CI 1.56-3.59), and severe (RR 5.70, 95% CI 3.00-10.85). No significant association was evident between anemia severity and haemorrhage (antepartum or postpartum) or sepsis, but there was a U-shaped association between anemia severity and pregnancy hypertension and pre-eclampsia specifically, with the lowest risk seen among those with mild or moderate anemia.
In Karnataka State, India, current management strategies for mild-moderate anemia in early pregnancy are associated with similar rates of adverse maternal or perinatal outcomes, and a lower risk of pregnancy hypertension and preeclampsia, compared with no anemia in early pregnancy. Future research should focus on risk mitigation for women with severe anemia, and the potential effect of iron supplementation for women with normal Hb in early pregnancy.
Blood pressure measurement is a marker of antenatal care quality. In well resourced settings, lower blood pressure cutoffs for hypertension are associated with adverse pregnancy outcomes. We aimed to ...study the associations between blood pressure thresholds and adverse outcomes and the diagnostic test properties of these blood pressure cutoffs in low-resource settings.
We did a secondary analysis of data from 22 intervention clusters in the Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised trials (NCT01911494) in India (n=6), Mozambique (n=6), and Pakistan (n=10). We included pregnant women aged 15–49 years (12–49 years in Mozambique), identified in their community by trained community health workers, who had data on blood pressure measurements and outcomes. The trial was unmasked. Maximum blood pressure was categorised as: normal blood pressure (systolic blood pressure sBP <120 mm Hg and diastolic blood pressure dBP <80 mm Hg), elevated blood pressure (sBP 120–129 mm Hg and dBP <80 mm Hg), stage 1 hypertension (sBP 130–139 mm Hg or dBP 80–89 mm Hg, or both), non-severe stage 2 hypertension (sBP 140–159 mm Hg or dBP 90–109 mm Hg, or both), or severe stage 2 hypertension (sBP ≥160 mm Hg or dBP ≥110 mm Hg, or both). We classified women according to the maximum blood pressure category reached across all visits for the primary analyses. The primary outcome was a maternal, fetal, or neonatal mortality or morbidity composite. We estimated dose-response relationships between blood pressure category and adverse outcomes, as well as diagnostic test properties.
Between Nov 1, 2014, and Feb 28, 2017, 21 069 women (6067 in India, 4163 in Mozambique, and 10 839 in Pakistan) contributed 103 679 blood pressure measurements across the three CLIP trials. Only women with non-severe or severe stage 2 hypertension, as discrete diagnostic categories, experienced more adverse outcomes than women with normal blood pressure (risk ratios 1·29–5·88). Using blood pressure categories as diagnostic thresholds (women with blood pressure within the category or any higher category vs those with blood pressure in any lower category), dose-response relationships were observed between increasing thresholds and adverse outcomes, but likelihood ratios were informative only for severe stage 2 hypertension and maternal CNS events (likelihood ratio 6·36 95% CI 3·65–11·07) and perinatal death (5·07 3·64–7·07), particularly stillbirth (8·53 5·63–12·92).
In low-resource settings, neither elevated blood pressure nor stage 1 hypertension were associated with maternal, fetal, or neonatal mortality or morbidity adverse composite outcomes. Only the threshold for severe stage 2 hypertension met diagnostic test performance standards. Current diagnostic thresholds for hypertension in pregnancy should be retained.
University of British Columbia, the Bill & Melinda Gates Foundation.
Background:
PIERS on the Move (POM) is a mobile health application developed to support community health workers identification and management of women at risk of adverse outcomes from pre-eclampsia. ...The objective of this study was to evaluate the impact of using POM in Pakistan on Lady Health Workers' (LHWs) knowledge and self-efficacy related to caring for women with pre-eclampsia, and their perception of usefulness of the tool.
Methodology:
An evaluation was designed for health care workers involved in the Community-Level Intervention for Pre-eclampsia (CLIP) cluster randomized trial from 2014 to 2016 in Sindh Province, Pakistan (NCT01911494). A semi-structured focus group guide was developed based on the Technology Acceptance Model (TAM), which theorizes that an individual's behavioral intention to use a system is determined by perceived usefulness and ease of use. Preliminary qualitative analysis was undertaken by the Pakistan and Canadian teams to create a coding framework for full qualitative analysis, which was completed using NVivo12.
Results:
Three key informant interviews were conducted with two Lady Health Supervisors and one Senior Medical Officer. Sixty-two LHWs were included in three focus group discussions. LHWs found the POM app easy to use and useful for their work as a helpful repository for maternal health information and guiding counseling and management of pre-eclampsia. LHWs reported increased knowledge and confidence in their work. Availability of clinical homecare, including postpartum, was felt to positively impact healthcare provided to pregnant and postpartum women. Potential community level impacts included strengthening relationships between health care providers and communities and between LHWs and the health system. LHWs shared reports of earlier care-seeking and increased awareness of maternal health issues by community members.
Conclusions:
LHWs carry a large burden of responsibility for community health in rural Pakistan and appreciated the investment in their skills and capacity during the CLIP trial with the POM app. Investing in communications technology for community health workers through improved referrals and follow up may strengthen cohesiveness of the health system overall.
Intensive care unit (ICU) outcome prediction models, such as Acute Physiology And Chronic Health Evaluation (APACHE), were designed in general critical care populations and their use in obstetric ...populations is contentious. The aim of the CIPHER (Collaborative Integrated Pregnancy High-dependency Estimate of Risk) study was to develop and internally validate a multivariable prognostic model calibrated specifically for pregnant or recently delivered women admitted for critical care.
A retrospective observational cohort was created for this study from 13 tertiary facilities across five high-income and six low- or middle-income countries. Women admitted to an ICU for more than 24 h during pregnancy or less than 6 weeks post-partum from 2000 to 2012 were included in the cohort. A composite primary outcome was defined as maternal death or need for organ support for more than 7 days or acute life-saving intervention. Model development involved selection of candidate predictor variables based on prior evidence of effect, availability across study sites, and use of LASSO (Least Absolute Shrinkage and Selection Operator) model building after multiple imputation using chained equations to address missing data for variable selection. The final model was estimated using multivariable logistic regression. Internal validation was completed using bootstrapping to correct for optimism in model performance measures of discrimination and calibration.
Overall, 127 out of 769 (16.5%) women experienced an adverse outcome. Predictors included in the final CIPHER model were maternal age, surgery in the preceding 24 h, systolic blood pressure, Glasgow Coma Scale score, serum sodium, serum potassium, activated partial thromboplastin time, arterial blood gas (ABG) pH, serum creatinine, and serum bilirubin. After internal validation, the model maintained excellent discrimination (area under the curve of the receiver operating characteristic (AUROC) 0.82, 95% confidence interval (CI) 0.81 to 0.84) and good calibration (slope of 0.92, 95% CI 0.91 to 0.92 and intercept of -0.11, 95% CI -0.13 to -0.08).
The CIPHER model has the potential to be a pragmatic risk prediction tool. CIPHER can identify critically ill pregnant women at highest risk for adverse outcomes, inform counseling of patients about risk, and facilitate bench-marking of outcomes between centers by adjusting for baseline risk.
BackgroundThe Community-Level Interventions for Pre-eclampsia (CLIP) trials (NCT01911494) in India, Pakistan and Mozambique (February 2014–2017) involved community engagement and task sharing with ...community health workers for triage and initial treatment of pregnancy hypertension. Maternal and perinatal mortality was less frequent among women who received ≥8 CLIP contacts. The aim of this analysis was to assess the incremental costs and cost-effectiveness of the CLIP intervention overall in comparison to standard of care, and by PIERS (Pre-eclampsia Integrated Estimate of RiSk) On the Move (POM) mobile health application visit frequency.MethodsIncluded were all women enrolled in the three CLIP trials who had delivered with known outcomes by trial end. According to the number of POM-guided home contacts received (0, 1–3, 4–7, ≥8), costs were collected from annual budgets and spending receipts, with inclusion of family opportunity costs in Pakistan. A decision tree model was built to determine the cost-effectiveness of the intervention (vs usual care), based on the primary clinical endpoint of years of life lost (YLL) for mothers and infants. A probabilistic sensitivity analysis was used to assess uncertainty in the cost and clinical outcomes.ResultsThe incremental per pregnancy cost of the intervention was US$12.66 (India), US$11.51 (Pakistan) and US$13.26 (Mozambique). As implemented, the intervention was not cost-effective due largely to minimal differences in YLL between arms. However, among women who received ≥8 CLIP contacts (four in Pakistan), the probability of health system and family (Pakistan) cost-effectiveness was ≥80% (all countries).ConclusionThe intervention was likely to be cost-effective for women receiving ≥8 contacts in Mozambique and India, and ≥4 in Pakistan, supporting WHO guidance on antenatal contact frequency.Trial registration numberNCT01911494.
Abstract Objective To assess the incremental value of blood oxygen saturation (SpO2 ) as a predictor in the miniPIERS model, a risk prediction model for adverse outcomes among women with a diagnosis ...of hypertensive disorder of pregnancy (HDP) in low-resourced settings. Methods Using data from a prospective cohort including 852 women admitted to hospital for a HDP, the association between SpO2 and adverse maternal outcome was assessed using logistic regression. The miniPIERS model was recalibrated and extended to include SpO2 . The incremental value of adding SpO2 to the model was measured using a net reclassification index (NRI), sensitivity, specificity, positive and negative predictive values, and likelihood ratios. Results SpO2 of < 93% was associated with a 30-fold increase in risk (95% CI 14 to 68) of adverse maternal outcome compared to women with SpO2 > 97%. After recalibration and extension, the miniPIERS model including SpO2 (vs. not including SpO2 ) had improved sensitivity (32.8% vs. 49.6%) at the cost of minimally decreased specificity (91.5% vs. 96.2%) with a NRI of 0.122. Conclusion SpO2 is a significant independent predictor of risk in women with a HDP. Adding SpO2 to the miniPIERS model improved the model’s ability to correctly identify high-risk patients who would benefit most from interventions.
Hypertensive disorders are the second highest direct obstetric cause of maternal death after haemorrhage, accounting for 14% of maternal deaths globally. Pregnancy hypertension contributes to ...maternal deaths, particularly in low- and middle-income countries, due to a scarcity of doctors providing evidence-based emergency obstetric care. Task-sharing some obstetric responsibilities may help to reduce the mortality rates. This study was conducted to assess acceptability by the community and other healthcare providers, for task-sharing by community health workers (CHW) in the identification and initial care in hypertensive disorders in pregnancy.
This study was conducted in two districts of Karnataka state in south India. A total of 14 focus group discussions were convened with various community representatives: women of reproductive age (N = 6), male decision-makers (N = 2), female decision-makers (N = 3), and community leaders (N = 3). One-to-one interviews were held with medical officers (N = 2), private healthcare OBGYN specialists (N = 2), senior health administrators (N = 2), Taluka (county) health officers (N = 2), and obstetricians (N = 4). All data collection was facilitated by local researchers familiar with the setting and language. Data were subsequently transcribed, translated and analysed thematically using NVivo 10 software.
There was strong community support for home visits by CHW to measure the blood pressure of pregnant women; however, respondents were concerned about their knowledge, training and effectiveness. The treatment with oral antihypertensive agents and magnesium sulphate in emergencies was accepted by community representatives but medical practitioners and health administrators had reservations, and insisted on emergency transport to a higher facility. The most important barriers for task-sharing were concerns regarding insufficient training, limited availability of medications, the questionable validity of blood pressure devices, and the ability of CHW to correctly diagnose and intervene in cases of hypertensive disorders of pregnancy.
Task-sharing to community-based health workers has potential to facilitate early diagnosis of the hypertensive disorders of pregnancy and assist in the provision of emergency care. We identified some facilitators and barriers for successful task-sharing of emergency obstetric care aimed at reducing mortality and morbidity due to hypertensive disorders of pregnancy.
Pre-eclampsia and eclampsia are major causes of maternal morbidity and mortality. Magnesium sulphate is accepted as the anticonvulsant of choice in these conditions and is present on the WHO ...essential medicines list and the Indian National List of Essential Medicines, 2015. Despite this, magnesium sulphate is not widely used in India for pre-eclampsia and eclampsia. In addition to other factors, lack of availability may be a reason for sub-optimal usage. This study was undertaken to assess the availability and use of magnesium sulphate at public and private health care facilities in two districts of North Karnataka, India.
A facility assessment survey was undertaken as part of the Community Level Interventions for Pre-eclampsia (CLIP) Feasibility Study which was undertaken prior to the CLIP Trials (NCT01911494). This study was undertaken in 12 areas of Belagavi and Bagalkote districts of North Karnataka, India and included a survey of 88 facilities. Data were collected in all facilities by interviewing the health care providers and analysed using Excel.
Of the 88 facilities, 28 were public, and 60 were private. In the public facilities, magnesium sulphate was available in six out of 10 Primary Health Centres (60%), in all eight taluka (sub-district) hospitals (100%), five of eight community health centres (63%) and both district hospitals (100%). Fifty-five of 60 private facilities (92%) reported availability of magnesium sulphate. Stock outs were reported in six facilities in the preceding six months - five public and one private. Twenty-five percent weight/volume and 50% weight/volume concentration formulations were available variably across the public and private facilities. Sixty-eight facilities (77%) used the drug for severe pre-eclampsia and 12 facilities (13.6%) did not use the drug even for eclampsia. Varied dosing schedules were reported from facility to facility.
Poor availability of magnesium sulphate was identified in many facilities, and stock outs in some. Individual differences in usage were identified. Ensuring a reliable supply of magnesium sulphate, standard formulations and recommendations of dosage schedules and training may help improve use; and decrease morbidity and mortality due to pre-eclampsia/ eclampsia.
The CLIP trial was registered with ClinicalTrials.gov ( NCT01911494 ).
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).
Maternal mortality ratio is 276 per 100,000 live births in Pakistan. Eclampsia is responsible for one in every ten maternal deaths despite the fact that management of this disease is inexpensive and ...has been available for decades. Many studies have shown that health care providers in low and middle-income countries have limited training to manage patients with eclampsia. Hence, we aimed to explore the knowledge of different cadres of health care providers regarding aetiology, diagnosis and treatment of pre-eclampsia and eclampsia and current management practices.
We conducted a mixed method study in the districts of Hyderabad and Matiari in Sindh province, Pakistan. Focus group discussions and interviews were conducted with community health care providers, which included Lady Health Workers and their supervisors; traditional birth attendants and facility care providers. In total seven focus groups and 26 interviews were conducted. NVivo 10 was used for analysis and emerging themes and sub-themes were drawn.
All participants were providing care for pregnant women for more than a decade except one traditional birth attendant and two doctors. The most common cause of pre-eclampsia mentioned by community health care providers was stress of daily life: the burden of care giving, physical workload, short birth spacing and financial constraints. All health care provider groups except traditional birth attendants correctly identified the signs, symptoms, and complications of pre-eclampsia and eclampsia and were referring such women to tertiary health facilities. Only doctors were aware that magnesium sulphate is recommended for eclampsia management and prevention; however, they expressed fears regarding its use at first and secondary level health facilities.
This study found several gaps in knowledge regarding aetiology, diagnosis and treatment of pre-eclampsia among health care providers in Sindh. Findings suggest that lesser knowledge regarding management of pre-eclampsia is due to lack of refresher trainings and written guidelines for management of pre-eclampsia and presentation of fewer pre-eclamptic patients at first and secondary level health care facilities. We suggest to include management of pre-eclampsia in regular trainings of health care providers and to provide management protocols at all health facilities.
NCT01911494.
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