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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, 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