Malaria Pregnancy and Childbirth
Conditions
Interventions
IPTp
Sponsors
Liverpool School of Tropical Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Viable singleton pregnancy 2. Gestational age 16 to 28 weeks (inclusive) by LMP (if available) or fundal height 3. No history of IPTp use during this pregnancy 4. Willing to participate and complete the study schedule 5. Has provided written informed consent 6. Resident of study area and intending to stay in the area for the duration of the follow-up 7. Willing to deliver in the labour ward of the study clinic or hospital
Exclusion criteria
Exclusion criteria: 1. HIV positive or unknown HIV status 2. Multiple gestations 3. High risk pregnancy resulting in referral to tertiary delivery facilities according to local guidelines, these include: a. Age under 16 or over 40 b. Five or more previous pregnancies c. Pre-existing illness likely to cause complication of pregnancy (hypertension, diabetes, asthma, epilepsy, renal disease, fistula repair, leg or spine deformity) d. Two or more previous miscarriages or induced abortions e. Previous caesarian section delivery, vacuum extraction or symphysiotomy f. History of pregnancy or birth complications (pre-eclampsia or post-partum haemorrhage) 4. Severe anaemia requiring blood transfusion (Hb ¿ 7.0 g/dL) at enrolment 5. Known allergy or previous adverse reaction to any of the study drugs 6. Unable to give informed consent (for example due to mental disability) 7. Previous inclusion in the same study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. In women in their first or second pregnancy (G1-2): Small for gestational age, LBW or preterm birth;2. Multigravidae (G3+): Malaria infection at term and delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| Placental malaria (any species);Maternal malaria infection (peripheral blood) ;Peripheral malaria infection;Birth Weight;Gestational age;Small for gestational age;Maternal haemoglobin and anaemia;Miscarriage;Stillbirth;Composite endpoint of primary endpoint plus fetal loss;Infant Death;Malaria infection of the newborn;Foetal haemoglobin and anaemia;Incidence of documented clinical malaria episodes;Presence of any evidence of malaria infection at term;Incidence of other illness episodes;Incidence and prevalence of clinical malaria in infants;Prevalence of symptomatic infant anaemia;Incidence of other illness episodes in infants;SAFETY: severe cutaneous skin reaction in mothers;SAFETY: other serious adverse events;SAFETY: Congenital malformation;SAFETY: Neonatal jaundice;SAFETY: Lab test results;Tolerability outcomes;Immunology outcome | — |
Countries
Malawi
Contacts
Public ContactLinda Kalilani
Community Health, College of Medicine, Blantyre
Outcome results
None listed