The effect of worm infections during pregnancy on immunisations and infections in infants

The impact of helminths on the response to immunisation and on the incidence of infection and disease in childhood in Uganda

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN32849447

Enrollment

2500

Registered

2005-07-22

Start date

2003-04-01

Completion date

Unknown

Last updated

2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helminthiasis Infections and Infestations Helminthiasis

Interventions

1. Randomised, double-blind, placebo controlled trial of albendazole versus placebo and praziquantel versus placebo during pregnancy (all mothers treated with both six weeks after delivery) 2. Randomi

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Pregnant women (aged 14 to 47 years) in the second or third trimester 2. Resident in the study area 3. Planning to deliver at Entebbe Hospital 4. Willing to know Human Immunodeficiency Virus (HIV) status

Exclusion criteria

Exclusion criteria: 1. Anaemia (more than or equal to 8 g/dl), bloody diarrhoea 2. Clinical evidence of severe liver disease 3. History of adverse reaction to anthelminthics 4. Already enrolled in previous pregnancy 5. Abnormal pregnancy (e.g. bleeding)

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure(s): 1. Immune responses in infants: 1.1. To selected childhood vaccines 1.2. To selected infectious diseases 1.3. To selected helminths 2. Incidence of childhood diseases 3. Primary outcomes at age nine years 3.1. Reported wheeze in last 12 months 3.2. SPT positivity to any allergen 3.3. Allergen-specific IgE to any allergen Previous primary outcome measure(s): 1. Immune responses in infants: 1.1. To selected childhood vaccines 1.2. To selected infectious diseases 1.3. To selected helminths 2. Incidence of childhood diseases	—

Measure

Time frame

Current primary outcome measure(s): 1. Immune responses in infants: 1.1. To selected childhood vaccines 1.2. To selected infectious diseases 1.3. To selected helminths 2. Incidence of childhood diseases 3. Primary outcomes at age nine years 3.1. Reported wheeze in last 12 months 3.2. SPT positivity to any allergen 3.3. Allergen-specific IgE to any allergen Previous primary outcome measure(s): 1. Immune responses in infants: 1.1. To selected childhood vaccines 1.2. To selected infectious diseases 1.3. To selected helminths 2. Incidence of childhood diseases

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Secondary

Measure	Time frame
Current secondary outcome measure(s): 1. Measures of: 1.1. Anaemia 1.2. Growth 1.3. Development 2. Incidence of allergic disease events 3. Secondary outcomes at age nine years 3.1. Reported eczema in last 12 months 3.2. Visible flexural eczema 3.3. Forced expiratory volume in one second (FEV1) Previous secondary outcome measure(s): 1. Measures of: 1.1. Anaemia 1.2. Growth 1.3. Development 2. Incidence of allergic disease events	—

Measure

Time frame

Current secondary outcome measure(s): 1. Measures of: 1.1. Anaemia 1.2. Growth 1.3. Development 2. Incidence of allergic disease events 3. Secondary outcomes at age nine years 3.1. Reported eczema in last 12 months 3.2. Visible flexural eczema 3.3. Forced expiratory volume in one second (FEV1) Previous secondary outcome measure(s): 1. Measures of: 1.1. Anaemia 1.2. Growth 1.3. Development 2. Incidence of allergic disease events

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Countries

Uganda

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 28, 2026