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1 |1 | WHO Pregnancy Registry: pilot findings ART in Pregnancy, Breastfeeding and Beyond PEPFAR Meeting Johannesburg, South Africa, June 18-20, 2012 F.

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Presentation on theme: "1 |1 | WHO Pregnancy Registry: pilot findings ART in Pregnancy, Breastfeeding and Beyond PEPFAR Meeting Johannesburg, South Africa, June 18-20, 2012 F."— Presentation transcript:

1 1 |1 | 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

2 2 |2 | Table 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

3 3 |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 4 |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 5 |5 | Form 3: Assessment at birth

6 6 |6 | WHO Surface examination video – WHO Pregnancy Registry

7 7 |7 |

8 8 |8 | II. Intermediary results and lessons learnt

9 9 |9 | 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

10 10 | 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

11 11 | 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

12 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 Maternal Assessment at Birth Confirmatory Assessment of Congenital Anomalies detected at birth Database Confirmatory Assessment after Birth Review by Global BD Panel ANC and Labor ward staff

13 13 | 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

14 14 | 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

15 15 | 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) - D r Josaphat Byamugisha Burkina Faso ( Bobo Dioulasso) – Dr Halidou Tinto Brazil (Porto Alegre, Rondonia) - Dr Lavinia Schuler-Faccini

16 16 | Contacts Françoise Renaud-Théry, WHO/HIV, Toxicity Monitoring for ARVs, Melba Gomes, WHO/TDR, Special Programme for Research and Training in Tropical Diseases, Viviana Mangiaterra, WHO/RHR, Research Capacity, Policy and Programme Strengthening,


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