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WHO Pregnancy Registry: pilot findings

ART in Pregnancy, Breastfeeding and Beyond PEPFAR Meeting Johannesburg, South Africa, June 18-20, 2012. F. Renaud-Thery, WHO/HIV Melba Gomez, WHO/TDR V. Mangiaterra, WHO/RHR. WHO Pregnancy Registry: pilot findings. Table of content. Standardized tools available

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WHO Pregnancy Registry: pilot findings

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  1. ART in Pregnancy, Breastfeeding and Beyond PEPFAR Meeting Johannesburg, South Africa, June 18-20, 2012 F. Renaud-Thery, WHO/HIV Melba Gomez, WHO/TDR V. Mangiaterra, WHO/RHR WHO Pregnancy Registry: pilot findings

  2. Table of content • Standardized tools available • Intermediary results and lessons learnt • Contribution to birth defect surveillance for efavirenz use in option B+ • Rationale for work up-stream in ARV toxicity monitoring

  3. I. 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

  4. Data 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

  5. Form 3: Assessment at birth

  6. WHO Surface examination video – WHO Pregnancy Registry

  7. II. Intermediary results and lessons learnt

  8. 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

  9. 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

  10. Lessons 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

  11. Review by Global BD Panel Confirmatory Assessment after Birth Confirmatory Assessment of Congenital Anomalies detected at birth Labour/Delivery Neonatal and Maternal Assessment at Birth ANC Visit 2 – ANC Visit X Database Follow-up ANC Assessment/s ANC VISIT 1 ANC and Labor ward staff Enrollment & Initial ANC Assessment All or randomly selected women Woman presenting at ANC clinic

  12. III. WHO contribution to birth defect surveillance for efavirenz use in option B+ in PEPFAR supported countries • Collaborate 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

  13. 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

  14. 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

  15. Contacts • Françoise Renaud-Théry, WHO/HIV, Toxicity Monitoring for ARVs, theryf@who.int • Melba Gomes, WHO/TDR, Special Programme for Research and Training in Tropical Diseases, gomesm@who.int • Viviana Mangiaterra, WHO/RHR, Research Capacity, Policy and Programme Strengthening, mangiaterrav@who.int

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