1 |1 | WHO Pregnancy Registry: pilot findings ART in Pregnancy, Breastfeeding and Beyond PEPFAR...
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Transcript of 1 |1 | WHO Pregnancy Registry: pilot findings ART in Pregnancy, Breastfeeding and Beyond PEPFAR...
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WHO Pregnancy Registry: pilot findings
WHO Pregnancy Registry: pilot findings
ART in Pregnancy, Breastfeeding and Beyond PEPFAR MeetingJohannesburg, South Africa, June 18-20, 2012
F. Renaud-Thery, WHO/HIVMelba Gomez, WHO/TDRV. Mangiaterra, WHO/RHR
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Table of contentTable of content
I. Standardized tools available
II. Intermediary results and lessons learnt
III. Contribution to birth defect surveillance for efavirenz use in option B+
IV. Rationale for work up-stream in ARV toxicity monitoring
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I. Standardized tools availableI. Standardized tools available
Data collection forms (Case Report Forms – CRFs)
Guidance documents for the CRFs
SOPs
Training manuals for trainers and trainees
Surface examination video
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Data Collection FormsData Collection Forms
Form 1:Assessment, drug and medical history at ANC clinic
Form 2: Follow-up assessment during pregnancy (similar to Form 1)
Form 3: Assessment at birth
Form 4: Confirmatory assessment by specialist
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Form 3: Assessment at birthForm 3: Assessment at birth
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WHO Surface examination video – WHO Pregnancy RegistryWHO Surface examination video – WHO Pregnancy Registry
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II. Intermediary results and lessons learntII. Intermediary results and lessons learnt
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Intermediary results - May 2012 (1)Intermediary results - May 2012 (1)
Total enrolled= 1659; 7200 to be enrolled in 6 countries
Overall HIV positivity 6.4% (Kenya 8%, Uganda 15%)
ARV exposure 5%
Total outcomes known (baby examined at facility OR miscarriage/stillbirth at home)= 1372
Total yet to deliver= 0
Total miscarriages= 23
Total stillbirths= 12
Total neonatal deaths= 16
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Intermediary results, May 2012 (2)Intermediary results, May 2012 (2)
Total babies born with minor birth defects = 23
Total babies born with major birth defects= 16
Total babies born with birth defects who died after birth= 2
Number of neural tube defects= 3
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Lessons learntLessons learnt
Train all staff at the centre, in all aspects. This is good for the mother and baby and improves surveillance outcomes.
Provide continuous supervision
Check forms regularly
Support nurses. They will be worried about time spent in examining the babies taking time from patient care. May mean task shifting
Identify a local neonatologist. Some neonates will need clinical / surgical attention, and advice of a specialist may be crucial.
Home births/pregnancy monitoring: Involve community health workers to support with retention
12 | Woman presenting at ANC clinic
All or randomly selected women
Enrollment & Initial ANC Assessment
ANC VISIT 1
ANC Visit 2 – ANC Visit X
Follow-up ANC Assessment/s
Labour/Delivery
Neonatal and MaternalAssessment at Birth
Confirmatory Assessment of Congenital Anomalies detected at birth
Database
Confirmatory Assessment after
Birth Review by Global BD Panel
Review by Global BD Panel
ANC and Labor ward staff
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III. WHO contribution to birth defect surveillance for efavirenz use in option B+ in PEPFAR supported
countries
III. WHO contribution to birth defect surveillance for efavirenz use in option B+ in PEPFAR supported
countriesCollaborate in harmonization of case reporting forms
(CRFs), manual, surface examination video, standard training package
Collaborate in review of country plans
Work with PEPFAR, governments, ethical review committees, reproductive health and HIV national programmes and other stakeholders
Participate in technical guidance and assistance visits
International Birth Defects Panel to classify birth defects
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IV. Rational for upstream work in ARV toxicity monitoring
IV. Rational for upstream work in ARV toxicity monitoring
Targeted populations: pregnant women, infants/children
PMTCT B+ – Potential risk of teratogenicity with EFV in pregnancy– Renal and bone toxicity of TDF in utero
Beyond option B+: – Hypersensitivity and hepatotoxicity with NVP in pregnant women – CNS toxicity with EFV
Breastfeeding– Bone development in child (TDF)
Mix of approaches: birth defect surveillance, pregnancy registry, targeted spontaneous reporting
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Acknowledgments Acknowledgments
Kenya (Webuye and Bungoma) - Dr Edwin Were
Tanzania (Dar es Salaam, Muheza) - Dr William Kisinza
Ghana (Dodowa and Accra) - Dr Christine Clerk
Uganda (Iganga and Kampala) - Dr Josaphat Byamugisha
Burkina Faso ( Bobo Dioulasso) – Dr Halidou Tinto
Brazil (Porto Alegre, Rondonia) - Dr Lavinia Schuler-Faccini
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Contacts Contacts
Françoise Renaud-Théry, WHO/HIV, Toxicity Monitoring for ARVs, [email protected]
Melba Gomes, WHO/TDR, Special Programme for Research and Training in Tropical Diseases, [email protected]
Viviana Mangiaterra, WHO/RHR, Research Capacity, Policy and Programme Strengthening, [email protected]