Anaemia, Malaria in Pregnancy, Sexually Transmitted Infections
Conditions
Keywords
Plasmodium falciparum, Plasmodium vivax, azithromycin, sulphadoxine pyrimethamine, low birth weight, haemoglobin, Chlamydia trachomatis, Neisseria gonorrhoeae, Treponema pallidum
Brief summary
The purpose of this study is to determine whether repeated courses of sulphadoxine-pyrimethamine (SP) in combination with azithromycin given at Antenatal Clinic, leads to lower rates of low birth weight deliveries (\<2.5 kg) among Papua New Guinean women, than the current standard treatment of SP and chloroquine.
Interventions
DRUGchloroquine, sulphadoxine pyrimethamine, LLIN
\> 50Kg: chloroquine base 150 mg 4 tablets daily for 3 days, plus sulphadoxine pyrimethamine 1500/75 mg single dose. \< 50 Kg: chloroquine base 150 mg 3 tablets daily for 3 days, plus sulphadoxine pyrimethamine 1500/75 mg single dose. Given at enrolment, 14-26 weeks gestation, by mouth.
DRUGazithromycin, sulphadoxine pyrimethamine, LLIN
sulphadoxine pyrimethamine (1500 mg/75 mg as single dose) plus azithromycin (1 g twice daily for 2 days). Given three times by mouth at monthly intervals, commencing at between 14 and 26 weeks gestation.
Sponsors
Papua New Guinea Institute of Medical Research
The University of Western Australia
Walter and Eliza Hall Institute of Medical Research
University of Barcelona
University of Melbourne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* pregnant * 14-26 weeks'gestation * permanent resident of study area * exclusive use of study health facilities for primary health care * Age is between 16 and 49 years
Exclusion criteria
* Known chronic illness, e.g. TB, diabetes, renal failure * Severe anaemia requiring hospitalisation (Hb \< 6 g/dl accompanied by symptoms requiring urgent treatment) * permanent disability, that prevents or impedes study participation and/or comprehension * Known multiple pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of women delivering low birth weight babies, <2500 g | At delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean maternal hemoglobin concentration at delivery, and proportion of women anaemic (Hb < 11 g/dl). | At delivery | — |
| Prevalence (at enrolment, second treatment, and delivery) and consequences (maternal haemoglobin, birth weight and placental pathology) of P. vivax infection in pregnancy | up to 26 weeks | From enrolment at 14-26 weeks gestation, until delivery |
| Incidence of symptomatic malaria during pregnancy | Up to 26 weeks | From enrolment at 14-26 weeks until delivery |
| Proportion of women carrying azithromycin-sensitive sexually transmitted infections at second treatment visit (28-34 weeks). | 28-34 week gestation study visit | — |
| Incidence of Adverse Events, including severe adverse events (SAEs), and AEs possibly or probably associated with study medications | 14-26 weeks | From enrolment at 14-26 weeks gestation until delivery |
| Prevalence of P falciparum at delivery in peripheral, placental and cord blood films and on placental histology | at delivery | — |
| Prevalence and antibiotic sensitivity patterns of S. pneumoniae in nasopharyngeal swabs collected at delivery | at delivery | — |
| Maternal, perinatal and infant mortality rates | Mothers; up to 32 weeks, from enrolment at 14-26 weeks gestation, until delivery. Pernatal: 16 weeks, from 28 weeks gestation to 4 weeks of age. Infant: from live birth to 1 year of age | maternal mortality is during pregnancy and until 6 weeks post partum. Perinatal mortality is from 28 weeks gestation until 6 weeks postpartum. Infant mortality is from irth to 12 months of age |
| Impact of IPTp on development of immunity to malaria in pregnancy | at delivery | — |
| Characteristics of parasites infecting pregnant women | Up to 26 weeks, from 14-26 weeks gestation until delivery | — |
| Prevalence of drug resistance markers in parasites infecting women in late pregnancy, particularly in the P falciparum and P vivax dihydrofolate reductase and dihydropteroate synthase enzymes, associated with SP resistance | at delivery | — |
Countries
Papua New Guinea
Outcome results
None listed