Gestational Sulfadoxine-pyrimethamine and Azithromycin Treatment to Prevent Preterm Birth

StatusActive, Not Recruiting
PhasePhase 3
Started

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Record History

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  1. Study completion date: Dec 31, 2025 to Dec 31, 2027v13
  2. Re-verified, no change to tracked fieldsv12
  3. Study completion date: Jun 2022 to Dec 31, 2025v11
  4. Study completion date: Jun 2020 to Jun 2022v10
  5. Primary endpoints revised (2)v9 Show 6 more changesShow less
    • Trial status: Completed to Active, Not Recruiting
    • Primary completion date: May 2007 to Jun 2007
    • Study completion date: Mar 2012 to Jun 2020
    • Secondary endpoints: 14 to 32
    • Study description expanded, about 79 words
    • Publications: 11 to 12
Show 7 earlier versionsHide 7 earlier versions
  1. Publications: 8 to 11v8
  2. Study completion date changed from estimate of Apr 2011 to Mar 2012
    • Trial status: Active, Not Recruiting to Completed
    • Publications: 5 to 8
    v7
  3. Primary completion date: May 2007
    • Study completion date: Apr 2007 to Apr 2011
    • Secondary endpoints: details revised at 14 of 14 entries
    • Study arms: 0 to 3
    v6
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v5
  5. Study completion date: Feb 2007 to Apr 2007
    • Study description expanded, about 7 words
    v4
  6. Re-verified, no change to tracked fieldsv3
  7. Interventions: Sulfadoxine-pyrimethamine at 4-week intervals (Drug), Sulfadoxine-pyrimethamine every 4-w + azithromycin twice (Drug)… to Sulfadoxine-pyrimethamine at 4-week intervals (Drug), Sulfadoxine-pyrimethamine every 4 weeks + azithromycin twice (Drug)…
    • Eligibility criteria expanded, about 1 word
    • Study title shortened, about 3 words
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to examine whether treatment of pregnant Malawian women with repeated doses of sulfadoxine-pyrimethamine and azithromycin antibiotics will prevent preterm deliveries and result in other health benefits both for the mother and the foetus/newborn.
Trial Details
NCT Number NCT00131235
Lead Sponsor Tampere University
Collaborators: Academy of Finland, Foundation for Paediatric Research, Finland
Conditions
(from sponsor)		 Malaria, Sexually Transmitted Diseases, Preterm Birth, Pregnancy
Related terms Malaria, Premature Birth, Sexually Transmitted Diseases
Enrollment 1,320 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov