Focus of Surgical Care of Ugandan Children

Hospital-based Birth Defects Surveillance in Kampala,

Uganda

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Linda Barlow-Mosha, MD MPHOn behalf of the BD Surveillance Team

Makerere University- Johns Hopkins University Research Collaboration Kampala-Uganda

28 Sep 2015Metropole Hotel

Protocol TeamMUJHUPhilippa Musoke, MBChB, Ph.D. – Principal investigatorLinda Barlow-Mosha, M.D., MPH Mulago HospitalJosephat Byamugisha, MBChB, MMed (OBS &GYN) PhD, Head of Department

Christine Biryabarema, MBChB, MMed, Senior consultant Obstetrician & Gyanecologist

Evelyn Nabunya, MBChB, MMed, Clinical Head, Dept. of Obstetrics and Gynaecology

Jolly Nankunda, MBChB, MMed, Mulago Hospital, Uganda CDCDhelia Williamson, Ph.D.

Diana Valencia, Ph.D | 2

Background

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• Globally 7.9 million children born with birth defects (BD) annually• 3.3 million die annually from birth defects• Limited data on the prevalence of birth defects in sub-Saharan

Africa• Purpose of this study:

• To establish a hospital-based birth defect surveillance system• To conduct a nested case-control study to describe maternal risk

factors associated with birth defects

Background• In Uganda, HIV prevalence is 8% among pregnant women• Initially EFV was not indicated for use in the first trimester

– An increase risk of neural tube defects (NTD) was reported in animal studies and a few human case reports

• Preferred Antiretroviral regimen – EFV/TDF/XTC (Option B+)– In 2012, panel of experts reviewed evidence of safety for EFV in early pregnancy – Based on Antiretroviral Program Registry from developed countries and passively

reported by physicians as well as a few studies – No increase risk of BD compared to other antiretrovirals – Need for more evidence of safety in developing countries with large numbers of

women on EFV | 4

Why Uganda?

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• Limited data on prevalence of birth defects in Uganda– Data that are available come from small studies* and March of Dimes

Global Report on BD 2006– Prevalence ranges from 20 to 60 per 1000 live births*

• 124,000 (7%)** of pregnant women in ANC are HIV positive• 70% of HIV+ mothers received ARVs (including Option B+)**• In preparation facilities identified with large number of deliveries• Available resources – number of deliveries, staffing, hospital

records/documentation, data collection, and patient flow*Simpkiss,1961; Ndibazza,2011; Ochieng,2011; **; HMIS,2013

Study Design

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• Establish Hospital-based surveillance system– 4 participating hospitals in Kampala (48,000 births/ year)

• Mulago, Mengo, Nsambya and Rubaga Hospitals

• Represents 75% of births occurring in hospitals within Kampala

• Case-control study to determine if maternal use of ART (Option B+ regimen) or cotrimoxazole (concomitant medication) during early pregnancy is associated with higher risk of BD– Prospective enrollment: 1 case: 3 controls, matched by birth hospital– Duration 4 years (total of approximately 192,000 births)

Design

• Selected 10 major external birth defects – NTD (Spina bifida with and without hydrocephalus, encephalocoele,

anencephaly)– Abdominal wall defects (Gastroschisis, Omphalocele)– Anotia/ Anopthalmia– Cleft lip/ and palate– Hypospadius– Talipes Equinovarus/ other Limb deficiencies

• Active case ascertainment

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Neural Tube Defects

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Abdominal wall defects

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Eye Defects - Anopthalmia

Cryptophthalmos Coloboma

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Ear Defects - Anotia/Microtia

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Cleft Lip and Palate

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Talipes Equinovarus

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Limb DeficienciesComplete or partial absence of distal structures of a limb in a transverse plane at the point where the deficiency begins, with proximal structures being essentially intact

Source: CDC-Beijing Medical University collaborative project

Congenital complete absence of upper limbs/Amelia of upper limb (Q71.0)

Congenital complete absence of lower limb/Amelia of lower limb (Q72.0)

Congenital absence of both forearm and hand

(Q71.2)

Limb deficiencies | 4

Project Significance

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• First birth defects surveillance program in Uganda• Provides current data on baseline prevalence of birth defects in

Uganda • Identify potential risks associated with HIV treatment

– Population reassurance and potential better ART adherence/compliance

• Evaluate effects of other medications on occurrence of adverse birth outcomes (i.e., malaria, TB, and other new HIV drugs)

• Utilize findings to guide prevention, service provision, inform further studies, and expand surveillance to include other disorders present at birth

Lessons Learned so far…..

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• Need to ensure sustainability beyond funding time frame• Secure MOH’s interest in birth defects surveillance for the

country– Involve in training/ stakeholder’s meetings/ birth defects awareness

campaign

• Key elements - Piloting/Continuous improvement/ Patience

Lessons Learned

• Greatest challenges and how they were addressed – Examination of large number of deliveries in busy hospitals

• Hired surveillance midwives

– Access to medical records/documentation• Use of electronic data collection and real time quality control of data

– Provision of referral services for affected children• Create referral list for service provider• Establish a link to pediatric surgeon to provide services for

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Update of Birth Defects Surveillance

• Piloting in Upper and Lower Mulago initiated in August 2015• Surveillance launched in Upper Mulago 20 August 2015• Lower Mulago to be launched in October 2015• Planned Stakeholder Meeting early 2016• Hospitals will receive quarterly updates on progress/ activties

of the surveillance• Present preliminary data from 2 months of piloting and

surveillance activities | 18

Update on Birth Defects Piloting/Surveillance

Type of Neural tube defects Number

Spina bifida with hydrocephalus 4Spina bifida without hydrocephalus 1Encephalocoele 2Anencephaly 4Total 11

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Update on Birth Defects Piloting/SurveillanceOther Types of Birth Defects Number

Gastroschisis 2Eye & Ear defects 3Limb reduction defects 2Talipes Equinovarus 8Knee joint malformations 3Orofacial clefts 1Hypospadias 2Conjoined twins 1Amniotic band sequences 1Total 23

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Mwebale Nnyo

Thank you