Maternal and Child Health Commons^™

The Ability And Safety Of Community-Based Health Workers To Safely Initiate Lifesaving Therapies For Pre-Eclampsia In Ogun State, Nigeria: An Analysis Of 260 Community Treatments With Mgso4 And/Or Methyldopa, Akinmade A. Adepoju, Marianne Vidler, Adebayo A. Akadri, Ebun Jaiyesimi, Chimaobi C. Nwankpa, Oluwafayokemi O. Odubena, Sumedha Sharma, Larry Li, Domena Tu, Zulfiqar Ahmed Bhutta

Woman and Child Health

Objectives: To evaluate community-based health workers' ability to identify cases of hypertension in pregnancy, safely deliver methyldopa and magnesium sulphate and make referrals when appropriate.
Study design: This was part of Nigeria Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomized controlled trial (NCT01911494). Community-based Health Workers (CHW) recruited pregnant women from five Local Government Areas (clusters) and used mobile health aid for clinical assessment of pre-eclampsia.
Main outcome measures: The primary outcome was the number of adverse events that occurred after the administration of magnesium sulphate and/or methyldopa to pregnant women by CHWs.
Findings: Of 8790 women receiving mobile …

Operational Experiences Associated With The Implementation Of Near Point-Of-Care Early Infant Diagnosis Of Hiv In Myanmar: A Qualitative Study, Win Lei Yee, Hla Htay, Yasmin Mohamed, Claire E. Nightingale, Htay Htay Tin, Win Thein, Latt Latt Kyaw, Win Win Yee, Moe Myat Aye, Stanley Luchters

Population Health, East Africa

Background: Timely diagnosis and early initiation of life-saving antiretroviral therapy are critical factors in preventing mortality among HIV-infected infants. However, resource-limited settings experience numerous challenges associated with centralised laboratory-based testing, including low rates of testing, complex sample referral pathways and unacceptably long turnaround times for results. Point-of-care (POC) HIV testing for HIVexposed infants can enable same-day communication of results and early treatment initiation for HIV-infected infants. However, complex operational issues and service integration can limit utility and must be well understood prior to implementation. We explored and documented the challenges and enabling factors in implementing the POC Xpert® HIV-1 …

Blood Pressure Thresholds In Pregnancy For Identifying Maternal And Infant Risk: A Secondary Analysis Of Community-Level Interventions For Pre-Eclampsia (Clip) Trial Data, Jeffrey N. Bone, Laura A. Magee, Joel Singer, Hannah Nathan, Rahat Qureshi, Charfudin Sacoor, Esperança Sevene, Andrew Shennan, Mrutyunjaya B. Bellad, Zulfiqar Ahmed Bhutta

Centre of Excellence in Women and Child Health

Background: 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.
Methods: 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 …

Frequency Of Primiparous Mother Initiated Breastfeeding Earlier After Birth And Factors Associated With It In Sindh, Pakistan: A Secondary Analysis, Asma A. Bham, Sucheta Sharma, Akash Sardool, Umer F. Mujahid, Amrat Ayaz, Komal Valliani, Nawaal Maredia

Community Health Sciences

Background: Initiation of breastfeeding within one hour after delivery plays a vital role in a newborns life by not only increasing their survival rate but also reducing many life-threatening diseases in the newborn. The aim of the study was to determine frequency of early initiation of breastfeeding among primiparous mothers in a rural district of Thatta, Pakistan.
Methods: This study was conducted using survey data extracted from a cross-sectional study conducted in 2019 on prevalence of exclusive breastfeeding and factors associated with it among women in Thatta. The outcome was early initiation of breastfeeding. To determine factors associated with it, …

Probabilistic Measures Of Hiv-1 Transmission In Different Hiv-1 Key Population Groups Of Larkana, Pakistan, Syed Rizwan-Ul-Hasa, Abiha Abdullah, Shakil Arshad Siddiqui, Shakil Ahmed, Sharaf Ali Shah, Fatima Mir, Syed Hani Abidi

Medical College Documents

Objective: To estimate the probability of human immunodeficiency virus (HIV)-1 transmission from different key HIV population groups using probabilistic modelling.
Methods: This study was conducted in December 2020. A probabilistic model was used to estimate the probability of HIV-1 transmission from different key HIV population groups in Larkana. Our model was run on three probabilistic assumptions: 1) each replication gave two conceivable results: 'true' or 'false'; 2) the chance of giving a 'true' result is the same for each replication; and 3) the replications are independent - 'true' in one will not impact the likelihood of 'true' in another.
Results: …

Effectiveness Of Typhoid Conjugate Vaccine Against Culture-Confirmed Salmonella Enterica Serotype Typhi In An Extensively Drug-Resistant Outbreak Setting Of Hyderabad, Pakistan: A Cohort Study, Mohammad Tahir Yousafzai, Sultan Karim, Sonia Qureshi, Abdul Momin Kazi, Hina Memon, Amber Junejo, Zohra Khawaja, Najeeb Ur Rehman, Muhammad Sajid Ansari, Rafey Ali, Heera Mani Lohana, Farah Naz Qamar

Department of Paediatrics and Child Health

Background: Salmonella enterica serotype Typhi (S Typhi) is a major public health problem in low-income and middle-income countries. We aimed to investigate the effectiveness and impact of the typhoid conjugate vaccine Typbar-TCV against S Typhi among children in an outbreak setting of extensively drug-resistant (XDR) S Typhi in Pakistan.
Methods: This cohort study was done from Feb 21, 2018, to Dec 31, 2019. A census survey of all households located in the Qasimabad and Latifabad subdistricts of Hyderabad, Pakistan, was done at baseline, and 174 005 households were registered in the census. The Typbar-TCV immunisation campaign was initiated at temporary …

Predicting The Environmental Suitability For Onchocerciasis In Africa As An Aid To Elimination Planning, Elizabeth A. Cromwell, Joshua C P. Osborne, Thomas R. Unnasch, Maria-Gloria Basáñez, Katherine M. Gass, Kira A. Barbre, Elex Hill, Kimberly B. Johnson, Katie M. Donkers, Zulfiqar Ahmed Bhutta

Centre of Excellence in Women and Child Health

Recent evidence suggests that, in some foci, elimination of onchocerciasis from Africa may be feasible with mass drug administration (MDA) of ivermectin. To achieve continental elimination of transmission, mapping surveys will need to be conducted across all implementation units (IUs) for which endemicity status is currently unknown. Using boosted regression tree models with optimised hyperparameter selection, we estimated environmental suitability for onchocerciasis at the 5 × 5-km resolution across Africa. In order to classify IUs that include locations that are environmentally suitable, we used receiver operating characteristic (ROC) analysis to identify an optimal threshold for suitability concordant with locations where …

Risk Of Infection And Transmission Of Sars-Cov-2 Among Children And Adolescents In Households, Communities And Educational Settings: A Systematic Review And Meta-Analysis, Omar Irfan, Jiang Li, Kun Tang, Zhicheng Wang, Zulfiqar Ahmed Bhutta

Woman and Child Health

Background: There is uncertainty with respect to SARS-CoV-2 transmission in children (0-19 years) with controversy on effectiveness of school-closures in controlling the pandemic. It is of equal importance to evaluate the risk of transmission in children who are often asymptomatic or mildly symptomatic carriers that may incidentally transmit SARS-CoV-2 in different settings. We conducted this review to assess transmission and risks for SARS-CoV-2 in children (by age-groups or grades) in community and educational-settings compared to adults.
Methods: Data for the review were retrieved from PubMed, EMBASE, Cochrane Library, WHO COVID-19 Database, China National Knowledge Infrastructure (CNKI) Database, WanFang Database, Latin …

Role Of Community Engagement In Maternal Health In Rural Pakistan: Findings From The Clip Randomized Trial, Zahra Hoodbhoy, Sana Sadiq Sheikh, Rahat Qureshi, Javed Memon, Farrukh Raza, Mai-Lei Woo Kinshella, Jeffrey N. Bone, Marianne Vidler, Sumedha Sharma, Zulfiqar Ahmed Bhutta

Department of Paediatrics and Child Health

Background: Community-based strategies to promote maternal health can help raise awareness of pregnancy danger signs and preparations for emergencies. The objective of this study was to assess change in birth preparedness and complication readiness (BPCR) and pregnant women's knowledge about pre-eclampsia as part of community engagement (CE) activities in rural Pakistan during the Community Level Interventions for Pre-eclampsia (CLIP) Trial.
Methods: The CLIP Trial was a cluster randomized controlled trial that aimed to reduce maternal and perinatal morbidity and mortality using CE strategies alongside mobile health-supported care by community health care providers. CE activities engaged pregnant women at their homes …

Using Amanhi-Act Cohorts For External Validation Of Iowa New-Born Metabolic Profiles Based Models For Postnatal Gestational Age Estimation, Sunil Sazawal, Kelli K. Ryckman, Harshita Mittal, Muhammad Imran Nisar, Usma Mehmood, Amina Barkat, Farah Khalid, Muhammad Ilyas, Ambreen Nizar, Fyezah Jehan

Department of Paediatrics and Child Health

Background: Globally, 15 million infants are born preterm and another 23.2 million infants are born small for gestational age (SGA). Determining burden of preterm and SGA births, is essential for effective planning, modification of health policies and targeting interventions for reducing these outcomes for which accurate estimation of gestational age (GA) is crucial. Early pregnancy ultrasound measurements, last menstrual period and post-natal neonatal examinations have proven to be not feasible or inaccurate. Proposed algorithms for GA estimation in western populations, based on routine new-born screening, though promising, lack validation in developing country settings. We evaluated the hypothesis that models developed …

Longitudinal Association Between Parental-To-Child-Maltreatment And Self-Reported Generalized Anxiety Disorder Symptoms In Pakistani Adolescents, Maryam Pyar Ali Lakhdir, Ghazal Peerwani, Salman Muhammad Soomar, Apsara Ali, Salima Farooq, Naureen Akber Ali, Asif Khaliq, Muhammad Masood Kadir, Syed Iqbal Azam

Community Health Sciences

Background: Parent-to-child maltreatment is considered one of the risk factors for Generalized Anxiety Disorder (GAD) symptoms, but this hypothesis has not been adequately tested in Pakistani settings.
Aim: This study aimed to examine the association between parent-to-child maltreatment and the risk of developing GAD symptoms among adolescents.
Methods: The association of none to rare, occasionally, and frequently parent-to-child maltreatment with the incidence of GAD symptoms was investigated in a sample of 800 adolescents aged 11-17 years who were followed for two years. Parent-to-child maltreatment was assessed using ICAST-C (International child abuse screening tool). GAD Symptoms were determined by SCARED (Screen …

Management Of Maternal Depression: Qualitative Exploration Of Perceptions Of Healthcare Professionals From A Public Tertiary Care Hospital, Karachi, Pakistan, Makkiya Jawed, Nousheen Pradhan, Rozina Mistry, Amirah Nazir, Sualeha Shekhani, Tazeen Saeed Ali

Community Health Sciences

The lack of implementation and routine screening of management techniques at tertiary care hospitals leads to an increased burden of maternal depression. The consequences are borne emotionally, physically, and mentally by the mother, the child, the overall family, and society. Hence, it is vital to contextualize this mental disorder to design and implement effective healthcare interventions. The study is aimed to assess the knowledge and practices of healthcare professionals, in a tertiary care setting, who deal with depressive symptoms amongst mothers. It gauges whether a psychological screening criterion is being implemented by the clinical staff during prenatal and postnatal visits …

Contextual Challenges In The Implementation Of The Alliance For Maternal And Newborn Health Improvement, Prospective Cohort Study, An Experience From Rural Pakistan, Yaqub Wasan, Shabina Ariff, Amjad Hussain, Sheraz Ahmed, Mansoor A. Abro, Imran Ahmed, Atif Habib, Sajid Bashir Soofi

Centre of Excellence in Women and Child Health

Introduction: Improving maternal and newborn survival needs robust data on patterns of morbidity and mortality from well-characterized cohorts. It is equally important for researchers to document and understand the contextual challenges of data collection and how they are addressed.
Methods: This was a prospective cohort study implemented from December 2012 to August 2014 in Matiari, Pakistan. A total of 11,315 pregnancies were enrolled. Participants were approached at home for sequential data collection through the standard pretested structured questionnaires. Some indicators were sourced through health facility records. Information on field challenges gathered through field diaries and minutes of meetings with field …

A Qualitative Endline Evaluation Study Of Male Engagement In Promoting Reproductive, Maternal, Newborn, And Child Health Services In Rural Kenya, Adelaide Lusambili, Stefania Wisofschi, Constance Shumba, Peter Muriuki, Jerim Obure, Michaela Mantel, Lindsay Mossman, Rachel Pell, Lucy Nyaga, Anthony Ngugi, James Orwa, Stanley Luchters, Kennedy Mulama, Terrance J. Wade, Marleen Temmerman

Population Health, East Africa

Background: Globally, male involvement in reproductive, maternal, newborn, and child health (RMNCH) is associated with increased benefits for women, their children, and their communities. Between 2016 and 2020, the Aga Khan University implemented the Access to Quality of Care through Extending and Strengthening Health Systems (AQCESS), project funded by the Government of Canada and Aga Khan Foundation Canada (AKFC). A key component of the project was to encourage greater male engagement in RMNCH in rural Kisii and Kilifi, two predominantly patriarchal communities in Kenya, through a wide range of interventions. Toward the end of the project, we conducted a …

Translation And Validation Of Training Needs Analysis Questionnaire Among Reproductive, Maternal And Newborn Health Workers In Tanzania, Tumbwene Mwansisya, Columba Mbekenga, Kahabi Isangula, Loveluck Mwasha, Eunice Pallangyo, Grace Edwards, James Orwa, Michaela Mantel, Micheal Mugerwa, Leonard Subi, Secilia Mrema, David Siso, Edna Selestine, Marleen Temmerman

School of Nursing & Midwifery, East Africa

Background: Continuous professional development (CPD) has been reported to enhance healthcare workers’ knowledge and skills, improve retention and recruitment, improve the quality of patient care, and reduce patient mortality. Therefore, validated training needs assessment tools are important to facilitate the design of effective CPD programs.

Methods: A cross-sectional survey was conducted using self-administered questionnaires. Participants were healthcare workers in reproductive, maternal, and neonatal health (RMNH) from seven hospitals, 12 health centers, and 17 dispensaries in eight districts of Mwanza Region, Tanzania. The training needs analysis (TNA) tool that was used for data collection was adapted and translated into …

Direct Maternal Morbidity And The Risk Of Pregnancy-Related Deaths, Stillbirths, And Neonatal Deaths In South Asia And Sub-Saharan Africa: A Population-Based Prospective Cohort Study In 8 Countries, Imran Ahmed, Shabina Ariff, Zulfiqar Ahmed Bhutta, Muhammad Ilyas, Fyezah Jehan, Usma Mehmood, Karim Muhammad, Muhammad Imran Nisar, Sajid Bashir Soofi, Yaqub Wasan, Anita K. M. Zaidi

Woman and Child Health

Background: Maternal morbidity occurs several times more frequently than mortality, yet data on morbidity burden and its effect on maternal, foetal, and newborn outcomes are limited in low- and middle-income countries. We aimed to generate prospective, reliable population-based data on the burden of major direct maternal morbidities in the antenatal, intrapartum, and postnatal periods and its association with maternal, foetal, and neonatal death in South Asia and sub-Saharan Africa.
Methods and findings: This is a prospective cohort study, conducted in 9 research sites in 8 countries of South Asia and sub-Saharan Africa. We conducted population-based surveillance of women of reproductive …

Evaluation Of The Feasibility Of The Fast-M Maternal Sepsis Intervention In Pakistan: A Protocol, Sheikh Irfan Ahmed, Raheel Sikandar, Rubina Barolia, Bakhtawar M H. Khowaja, Kashif Ali Memon, James Cheshire, Catherine Dunlop, Arri Coomarasamy, Lumaan Sheikh, David Lissauer

Department of Obstetrics & Gynaecology

Background: Maternal sepsis is a life-threatening condition, defined by organ dysfunction caused by infection during pregnancy, childbirth, and the postpartum period. It is estimated to account for between one-tenth and half (4.7% to 13.7%) of all maternal deaths globally. An international stakeholder group, including the World Health Organization, developed a maternal sepsis management bundle called "FAST-M" for resource-limited settings through a synthesis of evidence and international consensus. The FAST-M treatment bundle consists of five components: Fluids, Antibiotics, Source identification and control, assessment of the need to Transport or Transfer to a higher level of care and ongoing Monitoring (of the …

Uterine Artery Embolization Combined With Methotrexate For Broad Ligament Ectopic Pregnancy In A 30-Year Old Primigravida, Khurram Khaliq Bhinder, Azza Sarfraz, Zouina Sarfraz, Shaista Riaz, Samreen Aslam, Zouina Ameena

Department of Paediatrics and Child Health

We present the case of 30-year old primigravida female at 11 weeks' gestation who was diagnosed to have ectopic pregnancy on obstetric ultrasound. An MRI pelvis was ordered to assess invasion into the posterior myometrium which confirmed a single right-sided broad ligament-extra uterine pelvic ectopic pregnancy with extrinsic mass effect on the right lower uterine segment without frank myometrial invasion. On an urgent basis, a uterine artery embolization (UAE) was performed by targeting the right femoral artery. Selective catheterization was performed of both uterine arteries and the right side showed a major feeder of the gestational sac. Supplied dose of …

Comparative Analysis Of Pediatric Covid-19 Infection In Southeast Asia, South Asia, Japan, And China, Judith Ju Ming Wong, Qalab Abbas, Soo Lin Chua, Ririe Fachrina Malisie, Kah Min Pon, Tomohiro Katsuta, Hongxing Dang, Pei Chuen Lee, Muralidharan Jayashree, Quratulain Maha

Department of Paediatrics and Child Health

There is a scarcity of data regarding coronavirus disease 2019 (COVID-19) infection in children from southeast and south Asia. This study aims to identify risk factors for severe COVID-19 disease among children in the region. This is an observational study of children with COVID-19 infection in hospitals contributing data to the Pediatric Acute and Critical Care COVID-19 Registry of Asia. Laboratory-confirmed COVID-19 cases were included in this registry. The primary outcome was severity of COVID-19 infection as defined by the World Health Organization (WHO) (mild, moderate, severe, or critical). Epidemiology, clinical and laboratory features, and outcomes of children with COVID-19 …

Maternal Sociodemographic Factors And Antenatal Stress, Maheshwari Andhavarapu, James Orwa, Marleen Temmerman, Wangira Musana

Obstetrics and Gynaecology, East Africa

Antenatal stress has been associated with adverse birth outcomes such as fetal growth restriction, low birth weight, and preterm birth. Understanding key determinants of stress in a vulnerable pregnant population has the potential of informing development of targeted cost-effective interventions to mitigate against these adverse birth outcomes. We conducted a secondary analysis of data from 150 pregnant women attending antenatal care services at a rural referral hospital in Kenya. The participants completed a sociodemographic and clinical questionnaire, the Cohen’s Perceived Stress Scale (PSS) and gave a hair sample for cortisol and cortisone analysis. The association between selected sociodemographic predictors (age, …

Evaluating Motor Performance With The Bruininks-Oseretsky Test Of Motor Proficiency In Impoverished Pakistani Children, Zehra Habib Hasan, Fariha Shaheen, Arjumand Rizvi, Jelena Obradovic, Aisha Khan Yousafzai

Department of Paediatrics and Child Health

Objective: To evaluate the sensitivity of the modified Brief Form of Bruininks Oseretsky Test in identifying motor differences secondary to malnutrition and poverty.
Methods: This longitudinal cohort study was conducted at Nowshero Feroze, Sindh from 2013 to 2014 and comprised data drawn from children who participated in a randomised controlled trial, that assessed responsive stimulation and nutrition interventions in the first two years of life. Outcome measures included motor development assessed using Brief Form of Bruininks Oseretsky Test, child anthropometry and household economic and demographic information. Data was analysed using SPSS 15 and STATA 12.
Results: Of the 1058 children, …

Impact Of Local Terminology On The Design Of A Community-Based Diagnostic And Management Algorithm For Postpartum Sepsis: Findings Of Formative Research, Shabina Ariff, Fatima Mir, Wafa Aftab, Farrukh Raza, Shujaat Zaidi, Sheraz Memon, Amnesty Lefevre, Linda A. Bartlett, Peter Winch, Sajid Bashir Soofi, Zulfiqar Ahmed Bhutta

Department of Paediatrics and Child Health

Background: Postpartum sepsis is one of the leading causes of maternal mortality and morbidity in developing countries. This formative research elicits local terms used for postpartum illnesses and symptoms of postpartum sepsis with the aim of improving postpartum diagnosis and management in Pakistan.
Methods: We conducted 34 in-depth interviews with recently delivered women (RDW), traditional birth attendants (TBAs), healthcare providers and family members of RDW from rural Sindh to explore local Sindhi terms used to describe postpartum sepsis and related symptoms. During interviews, all participants were asked to orally free list common symptoms of postpartum illnesses; those who were aware …

Improved First Trimester Maternal Iodine Status With Preconception Supplementation: The Women First Trial, Amy E. Young, Jennifer F. Kemp, Charis Uhlson, Jamie L. Westcott, Sumera Aziz Ali, Sarah Saleem, Ana Garcès, Lester Figueroa, Manjunath S. Somannavar, Shivaprasad S. Goudar

Community Health Sciences

Maternal iodine (I) status is critical in embryonic and foetal development. We examined the effect of preconception iodine supplementation on maternal iodine status and on birth outcomes. Non-pregnant women in Guatemala, India and Pakistan (n ~ 100 per arm per site) were randomized ≥ 3 months prior to conception to one of three intervention arms: a multimicronutrient-fortified lipid-based nutrient supplement containing 250-μg I per day started immediately after randomization (Arm 1), the same supplement started at ~12 weeks gestation (Arm 2) and no intervention supplement (Arm 3). Urinary I (μg/L) to creatinine (mg/dl) ratios (I/Cr) were determined at 12 weeks …

Cost Estimation Alongside A Multi-Regional, Multi-Country Randomized Trial Of Antenatal Ultrasound In Five Low-And-Middle-Income Countries, B W. Bresnahan, E Vodicka, J B. Babigumira, Ashar Muhammad Malik, F Yego, A Lokangaka, B M. Chitah, Z Bauer, H Chavez, Sarah Saleem

Community Health Sciences

Background: Improving maternal health has been a primary goal of international health agencies for many years, with the aim of reducing maternal and child deaths and improving access to antenatal care (ANC) services, particularly in low-and-middle-income countries (LMICs). Health interventions with these aims have received more attention from a clinical effectiveness perspective than for cost impact and economic efficiency.
Methods: We collected data on resource use and costs as part of a large, multi-country study assessing the use of routine antenatal screening ultrasound (US) with the aim of considering the implications for economic efficiency. We assessed typical antenatal outpatient and …

Predictors Of Iron Consumption For At Least 90 Days During Pregnancy: Findings From National Demographic Health Survey, Pakistan (2017-2018), Sumera Aziz Ali, Savera Aziz Ali, Shama Razzaq, Nayab Khowaja, Sarah Gutkind, Fazal Ur Rehman, Nadir Suhail

Section of Internal Medicine

Background: Iron supplementation is considered an imperative strategy for anemia prevention and control during pregnancy in Pakistan. Although there is some evidence on the predictors of iron deficiency anemia among Pakistani women, there is a very limited understanding of factors associated with iron consumption among Pakistani pregnant women. Thus, this study aimed to investigate the predictors of iron consumption for at least ≥90 days during pregnancy in Pakistan.
Methods: We analyzed dataset from the nationally representative Pakistan Demographic Health Survey 2017-2018. The primary outcome of the current study was the consumption of iron supplementation for ≥90 days during the pregnancy …

Randomised Trials At The Level Of The Individual, Jay J H. Park, Nathan Ford, Denis Xavier, Per Ashorn, Rebecca F. Grais, Zulfiqar Ahmed Bhutta, Herman Goossens, Kristian Thorlund, Maria Eugenia Socias, Edward J. Mills

Centre of Excellence in Women and Child Health

In global health research, short-term, small-scale clinical trials with fixed, two-arm trial designs that generally do not allow for major changes throughout the trial are the most common study design. Building on the introductory paper of this Series, this paper discusses data-driven approaches to clinical trial research across several adaptive trial designs, as well as the master protocol framework that can help to harmonise clinical trial research efforts in global health research. We provide a general framework for more efficient trial research, and we discuss the importance of considering different study designs in the planning stage with statistical simulations. We …

Economic And Cost-Effectiveness Analysis Of The Community-Level Interventions For Pre-Eclampsia (Clip) Trials In India, Pakistan And Mozambique, Jeffrey N. Bone, Asif R. Khowaja, Marianne Vidler, Beth A. Payne, Mrutyunjaya B. Bellad, Shivaprasad S. Goudar, Ashalata A. Mallapur, Khatia Munguambe, Rahat Qureshi, Zulfiqar Ahmed Bhutta

Woman and Child Health

Background: The 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.
Methods: Included were all women enrolled in the three …

A Clinical Audit Of Management Of Third And Fourth Degree Perineal Tears, Saida Abrar, Raheela Mohsin Rizvi, Urooj Kashif

Department of Obstetrics & Gynaecology

Objective: To perform a clinical audit of the practices related to the management of third and fourth degree perineal tears.
Methods: The retrorspective study was conducted in 2019 at the Aga Khan University Hospital, Karachi, and comprised medical records from January 2008 to December 2018 of women having singleton term vaginal delivery and sustaining obstetric anal sphincter injuries. The change in practices regarding tear management was compared with a previous audit done at the same institution in 2008. Data was analysed using SPSS 20.
Results: Of the 25,370 deliveries, 142(0.56%) sustained obstetric anal sphincter injuries. There was a significant increase …

Urgently Seeking Efficiency And Sustainability Of Clinical Trials In Global Health, Jay J H. Park, Rebecca F. Grais, Monica Taljaard, Etheldreda Nakimuli-Mpungu, Fyezah Jehan, Jean B. Nachega, Nathan Ford, Denis Xavier, Andre P. Kengne, Zulfiqar Ahmed Bhutta

Department of Paediatrics and Child Health

This paper shows the scale of global health research and the context in which we frame the subsequent papers in the Series. In this Series paper, we provide a historical perspective on clinical trial research by revisiting the 1948 streptomycin trial for pulmonary tuberculosis, which was the first documented randomised clinical trial in the English language, and we discuss its close connection with global health. We describe the current state of clinical trial research globally by providing an overview of clinical trials that have been registered in the WHO International Clinical Trial Registry since 2010. We discuss challenges with current …

How Covid-19 Has Fundamentally Changed Clinical Research In Global Health, Jay J H. Park, Robin Mogg, Gerald E. Smith, Etheldreda Nakimuli-Mpungu, Fyezah Jehan, Craig R. Rayner, Jeanine Condo, Eric H. Decloedt, Jean B. Nachega, Gilmar Reis, Edward J. Mills

Department of Paediatrics and Child Health

COVID-19 has had negative repercussions on the entire global population. Despite there being a common goal that should have unified resources and efforts, there have been an overwhelmingly large number of clinical trials that have been registered that are of questionable methodological quality. As the final paper of this Series, we discuss how the medical research community has responded to COVID-19. We recognise the incredible pressure that this pandemic has put on researchers, regulators, and policy makers, all of whom were doing their best to move quickly but safely in a time of tremendous uncertainty. However, the research community's response …