Status:
COMPLETED
Intermittent Preventive Treatment With Azithromycin-containing Regimens in Pregnant Women in Papua New Guinea
Lead Sponsor:
University of Melbourne
Collaborating Sponsors:
Papua New Guinea Institute of Medical Research
The University of Western Australia
Conditions:
Malaria in Pregnancy
Sexually Transmitted Infections
Eligibility:
FEMALE
16-49 years
Phase:
PHASE3
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 weig...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
2793 Patients enrolled
Trial Details
Trial ID
NCT01136850
Start Date
November 1 2009
End Date
January 1 2013
Last Update
April 23 2013
Active Locations (1)
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1
Papua New Guinea Institute of Medical Research
Madang, Madang Province, Papua New Guinea