1,200 pregnant women (600 HIV+ mothers and 600 HIV-controls) in their third trimester were enrolled from January 2016 to June 2019. Participants are being followed as mother-baby pairs at birth, within 10 days of life 6, 10, 14 24, 48, 72 and 96 weeks of age. At each visit clinical examinations are being used to assess health and the impact of environmental factors. In addition, questionnaires are administered and bio-samples for laboratory tests. The design of the study is non-interventional cohort but participants are being offered advice regarding health and hygiene.

maternal urine, stool, plasma, milk, cord blood, amniotic fluid, placenta, infant serum/plasma, dried blood spots and stool

HIV Infections

Immune Activation

Cormobidities

The University of Zimbabwe College of Health Science (UZ-CHS) BIRTH COHORT Study

HIV Exposure, Disease Acquisition and Progression Among Children: Role of Maternal Immunogenetics, Viral Genetic Diversity, HAART Exposure, Co-morbidities and Psycho-Social Status: (UZ-CHS Birth Cohort)

Comparison of morbidity of HEU vs. HUU infants, defined as impaired growth, immune- and neuro-development and/ or frequent clinically relevant infections

To determine any association of maternal HIV infection, HAART exposure.

To determine any association with maternal HIV and HAART exposure.

To determine any association of HAART exposure in utero and during breast feeding with pregnancy outcome, infant (HUU, HEU, HEI) growth and immune- and neuro-development.

To determine vertical transmission rates for HIV at birth and within the first 2 years of life and assess risk factors for transmission

HIV incidence rate among mother sero-negative at enrollment

To determine the association between maternal baseline and delivery HAART levels in different compartments and the relation of those to infant HIV transmission, mortality and morbidity.

To determine the association between antenatal immune dysregulation and infant death, growth and immune responses to vaccines.

To determine HIV drug resistance profiles in mother and infants unresponsive to HAART

To determine how CMV DNA is influenced by HIV infection, HAART use and as single infection or combined infections in HIV+ and HIV- women and determine the impact on pregnancy outcome and infant cmv vertical transmission

To determine how HBV infection infections in HIV+ and HIV- women and determine the impact on pregnancy outcome, infant vertical transmission

To determine HCV infections proportion in HIV positives and negatives and HIV+ and HIV- women and determine the impact on pregnancy outcome, infant incidence of congenital cmv infection

To determine syphilis infections proportion in HIV positives and negatives and the impact on pregnancy outcome, infant incidence of congenital syphilis infection

To determine the prevalence of helminthes infection using 18s sequencing and correlate with infant development of atopic dermatitis.

To determine the prevalence of maternal under and overnutrition using BMI and MUAC impact on pregnancy outcomes, infant mortality and morbidity.

To assess abnormalities in HIV + and HIV- including lipid profiles, bone, haematological (anemia) and hepatic toxicities associated with exposure to HAART among mothers and infants.

To determine infant non-infectious comorbidities (e.g. anaemia, atopic dermatitis, congenital infections and other conditions) and their impact on mortality and morbidity.

To assess delayed neuro-cognitive development using the Denver II tool in HUU, HEU and HEI infants and correlated with socio economic status and infectious diseases.

To determine humoural immune responses to EPI vaccines including antibody levels against measles, tetanus, diphtheria, pertussis, polio and rotavirus) in HUU, HEU and HEI infants.

To determine immune activation and systemic inflammatory biomarkers in HUU, HEU and HEI infants

To determine biomarkers for endothelial dysfunction including microbial translocation in HUU, HEU and HEI infants and association with household hygiene at delivery, 6, 48 and 96 weeks of age.

To determine antenatal reference ranges for MUAC, haemoglobin from FBC analyses, and biochemistry (kidney function, liver function tests, bone, lipid profiles) in mothers with a favourable outcome of pregnancy

To determine maternal- infant microbiota16S sequencing in pregnancy and relate it to infant immune development and atopy (anti-inflammatory (IL-4, -5, -13) and regulatory cytokines (IL-10, TGF-β) at delivery, 6 weeks 48 and 96 weeks of age.

Bacterial full genome metagenomics shotgun sequencing to identify the microbiota metabolic potential (i.e. bacterial genes present will be done) and mass spectrometry will be performed for analysis of small intestinal content (metabolome).

Wide range of nutritional profiles and HAART levels spectrometry will be performed for analysis of at least 700 metabolites including amino acids and lipids will be performed in plasma, breast milk and stool samples

To characterize pathogen genetic diversity including HIV, HBV, HCV, CMV subtypes, prevalent in our study population at time of infection

To determine host genetic markers for infectious disease susceptibility including human leukocyte antigen (HLA) and killer immunoglobulin like receptor (KIR) gene variants and their association with infection rates of HIV and co-infections in mothers and their infants.

Only anonymous data will be stored at local sites and transferred between sites for collaborative research efforts. All original data will be stored locally at the UZ-CHS for at least 10 years on suitable electronic devices. Data transfer with collaborating partners will be encrypted. using EGAcryptor. With our European partners we will follow the current European General Data Protection Regulation effective May 25, 2018.

Kerina Duri

Associate Professor

University of Zimbabwe

University Hospital Inselspital, Berne

University of Hamburg

University of Oxford

Wellcome Trust

University of Yaounde

University of Cape Town

Midlands State University, Zimbabwe

National Institute of Health Research, Zimbabwe

A 16 week acupuncture pretreatment followed by letrozole(LE). Acupuncture treatment will start on day 3-5 after a spontaneous period or after a withdrawal bleeding following progestin. All subjects will be requested to use contraception during the 16 week acupuncture pretreatment. They will receive acupuncture treatment three times a week. Each treatment session lasts for 30 minutes and can be separated by an interval of 1-3 days, with a maximum of 48 treatment sessions during 16 weeks. After 16 weeks of acupuncture treatment, LE will start on day 2-3 after a spontaneous period or after a withdrawal bleeding after progestin administration. The subjects will be instructed to have intercourse on a regular basis during the cycles.

LE alone. LE will be started on day 3-5 after a spontaneous period or a withdrawal bleeding following progestin. The subjects will be instructed to have intercourse on a regular basis during the cycles.

Polycystic Ovary Syndrome

Acupuncture treatment will start on day 3-5 after a spontaneous period or after a withdrawal bleeding following progestin. They will receive acupuncture treatment three times a week. Each treatment session lasts for 30 minutes and can be separated by an interval of 1-3 days, with a maximum of 48 treatment sessions during 16 weeks.

Pre-treatment acupuncture

Starting from 2.5mg daily from day 3-5 for 5 days after a spontaneous period or after a withdrawal bleeding following progestin, one time per day.Participants are treated for up to 4 cycles.

Letrozole

The First Affiliated Hospital of Guangzhou Medical University

The Clinical Trial of Acupuncture Pre-treatment on PCOS

Effect of Acupuncture Pre-treatment Combined With Letrozole on Live Birth in Infertile Women With Polycystic Ovary Syndrome

Loss of an intrauterine pregnancy before 20 completed weeks of gestation

Glucose and insulin concentrations, C-peptide, HbA1c, cholesterol, triglycerides, HDL-C and LDL-C

Weight, BMI, waist-to-hip circumference, FG and acne lesion counts

SF-36, ChiQOL, sleeping questionnaires, PCOS-QOL, Zung SAS, Zung SDS questionnaires and the quantization table of TCM syndromes about PCOS.

Hongxia Ma

Professor

The University of Hong Kong

The ESTEEM dietary pattern is similar to that in a Mediterranean diet associated with reduced risk of pre-eclampsia.
The intervention will include structured meal plans and grocery lists, recipes for healthy diet and appropriate choices at restaurants

The control group will be provided the usual antenatal dietary advice. This includes advice on healthy and physical activity in women with normal weight and obesity and overweight. Folic acid and vit D supplementation are provided as per national recommendations. Participants will provide outcome data at point of delivery and food frequency questionnaire at baseline and 36 weeks or delivery depending on which is sooner.

Non-randomised cohort of women with no metabolic risk factors will be followed up to delivery to collect outcome data

Pre-eclampsia

Obesity

Raised Lipids

High Blood Pressure

Insulin Resistance

Gestational Diabetes

Small for Gestational Age

Stillbirth

The key components of the diet are:
High intake of vegetables, nuts, non-refined grains, legumes and fruits;Moderate to high consumption of fish;Small to moderate intake of poultry and dairy products such as yoghurt and cheese;Low consumption of red meat and processed meat and avoidance of sugary drinks, fast food and high fat food;High fibre;Intake of nuts including walnuts and almonds that are rich sources of monounsaturated and polyunsaturated fatty acids (30 g/day);Olive oil to cook and dress salads as the main source of fat (0.5 l/week)
The intervention will include structured meal plans and grocery lists, recipes for healthy diet and appropriate choices at restaurants

Targeted ESTEEM diet

Non-randomised cohort

Barts Health NHS Trust

ESTEEM - Effect of Simple, Targeted Diet in Pregnant Women With Metabolic Risk Factors on Pregnancy Outcomes

Effect of Simple, Targeted Diet in Pregnant Women With Metabolic Risk Factors on Pregnancy Outcomes (ESTEEM): A Randomised Trial

Diagnosis of pre-eclampsia defined as:
new onset hypertension after 20 weeks gestation defined as systolic BP ≥ 140 mm Hg or diastolic BP ≥ 90 mmHg, in at least two readings AND New onset proteinuria defined as spot urine Protein/creatinine ratio (PCR) test greater than 30mg/mmol or >24 hour urine 300mg/24 hours or 2+ or more on standard urinary dipstick tests after 20 weeks gestation
superimposed pre-eclampsia in women with chronic hypertension or chronic proteinuria
women with eclamptic seizures with no hypertension or proteinuria
Diagnosis of gestational diabetes defined as:
fasting venous glucose of 5·1 mmol/L or higher or
2 h venous glucose of 8·5 mmol/L or higher or
combination of these

Queen Mary University of London

Intrahepatic Cholestasis of Pregnancy

Gestational Diabetes Mellitus

Guy's & St Thomas' NHS Foundation Trust

Imperial College Healthcare NHS Trust Hammersmith

The Metabolic Profile in Intrahepatic Cholestasis of Pregnancy and Diabetes Mellitus

A Longitudinal Study of Alterations in Metabolic Markers and Gut Hormones in Pregnant and Non-pregnant Patients With Intrahepatic Cholestasis of Pregnancy, Gestational Diabetes Mellitus and Normal Pregnant and Non-pregnant Controls

Any results and findings will be disseminated in research publications.

stillbirth/triglyceride

The University of Zimbabwe College of Health Science (UZ-CHS) BIRTH COHORT Study

The Clinical Trial of Acupuncture Pre-treatment on PCOS

ESTEEM - Effect of Simple, Targeted Diet in Pregnant Women With Metabolic Risk Factors on Pregnancy Outcomes

The Metabolic Profile in Intrahepatic Cholestasis of Pregnancy and Diabetes Mellitus

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