Intermittent Preventive Treatment With Azithromycin-containing Regimens in Pregnant Women in Papua New Guinea
Phase 3
Completed
- Conditions
- Malaria in PregnancySexually Transmitted InfectionsAnaemia
- Interventions
- Drug: chloroquine, sulphadoxine pyrimethamine, LLINDrug: azithromycin, sulphadoxine pyrimethamine, LLIN
- Registration Number
- NCT01136850
- Lead Sponsor
- University of Melbourne
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 2793
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SP, chloroquine treatment; bed net chloroquine, sulphadoxine pyrimethamine, LLIN Treatment course of sulphadoxine pyrimethamine and chloroquine on enrolment. Long lasting insecticide treated bed net 3 x SP plus azithromycin; bed nets azithromycin, sulphadoxine pyrimethamine, LLIN Three x monthly courses of azithromycin and sulphadoxine pyrimethamine plus long lasting insecticide treated bed net.
- Primary Outcome Measures
Name Time Method Proportion of women delivering low birth weight babies, <2500 g At delivery
- Secondary Outcome Measures
Name Time Method Prevalence of P falciparum at delivery in peripheral, placental and cord blood films and on placental histology at delivery 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 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 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
Trial Locations
- Locations (1)
Papua New Guinea Institute of Medical Research
🇵🇬Madang, Madang Province, Papua New Guinea