Gestational Sulfadoxine-pyrimethamine and Azithromycin Treatment to Prevent Preterm Birth

This study has been completed.
Sponsor:
Collaborators:
Academy of Finland
Foundation for Paediatric Research, Finland
Information provided by (Responsible Party):
Per Ashorn, University of Tampere
ClinicalTrials.gov Identifier:
NCT00131235
First received: August 16, 2005
Last updated: January 21, 2014
Last verified: January 2014

August 16, 2005
January 21, 2014
December 2003
May 2007   (final data collection date for primary outcome measure)
  • Proportion of preterm births [ Time Frame: once, after delivery ] [ Designated as safety issue: No ]
  • Number of serious and any adverse events [ Time Frame: Cumulative during pregnancy and neonatal period ] [ Designated as safety issue: Yes ]
  • Proportion of preterm births
  • Number of serious and any adverse events
Complete list of historical versions of study NCT00131235 on ClinicalTrials.gov Archive Site
  • Percentage of low birth weight babies [ Time Frame: Once, after delivery ] [ Designated as safety issue: No ]
  • Mean birth weight [ Time Frame: Once, after delivery ] [ Designated as safety issue: No ]
  • Mean duration of gestation [ Time Frame: Once, after delivery ] [ Designated as safety issue: No ]
  • Percentage of low chest circumference at birth [ Time Frame: Once, after delivery ] [ Designated as safety issue: No ]
  • Percentage of low chest or head circumference at birth [ Time Frame: Once, after delivery ] [ Designated as safety issue: No ]
  • Incidence of moderate underweight during infancy [ Time Frame: Cumulative during infancy ] [ Designated as safety issue: No ]
  • Perinatal, neonatal and infant mortality [ Time Frame: Cumulative during infancy ] [ Designated as safety issue: No ]
  • Mean maternal blood haemoglobin concentration at each antenatal visit and at 1, 3, and 6 months after delivery [ Time Frame: Several antenatal and postnatal visits ] [ Designated as safety issue: No ]
  • Percentage of women with mild, moderate or severe anaemia at every antenatal visit and at 1, 3, and 6 months after delivery [ Time Frame: Several antenatal and postnatal visits ] [ Designated as safety issue: No ]
  • Percentage of women with peripheral blood malaria parasitaemia and mean parasite density at enrolment, at 32 gestational weeks and at delivery [ Time Frame: at enrolment, at 32 weeks, and at delivery ] [ Designated as safety issue: No ]
  • Percentage of women with cord blood and placental malaria parasitaemia at delivery [ Time Frame: At delivery ] [ Designated as safety issue: No ]
  • Maternal weight gain during pregnancy [ Time Frame: Once after pregancy ] [ Designated as safety issue: No ]
  • Mean number of maternal illness days during pregnancy [ Time Frame: Cumulative during pregnancy ] [ Designated as safety issue: No ]
  • Prevalence of maternal chlamydia trachomatis, neisseria gonorrhoea, and vaginal trichomoniasis infection at 4 weeks after delivery [ Time Frame: At 4 weeks after delivery ] [ Designated as safety issue: No ]
  • Percentage of low birth weight babies
  • Mean birth weight
  • Mean duration of gestation
  • Percentage of low chest circumference at birth
  • Percentage of low chest or head circumference at birth
  • Incidence of moderate underweight during infancy
  • Perinatal, neonatal and infant mortality
  • Mean maternal blood haemoglobin concentration at each antenatal visit and at 1, 3, and 6 months after delivery
  • Percentage of women with mild, moderate or severe anaemia at every antenatal visit and at 1, 3, and 6 months after delivery
  • Percentage of women with peripheral blood malaria parasitaemia and mean parasite density at enrolment, at 32 gestational weeks and at delivery
  • Percentage of women with cord blood and placental malaria parasitaemia at delivery
  • Maternal weight gain during pregnancy
  • Mean number of maternal illness days during pregnancy
  • Prevalence of maternal chlamydia trachomatis, neisseria gonorrhoea, and vaginal trichomoniasis infection at 4 weeks after delivery
Not Provided
Not Provided
 
Gestational Sulfadoxine-pyrimethamine and Azithromycin Treatment to Prevent Preterm Birth
Lungwena Antenatal Intervention Study. A Single-centre Intervention Trial in Rural Malawi, Testing Maternal and Infant Health Effects of Presumptive Intermittent Treatment of Pregnant Women With Sulfadoxine-pyrimethamine and Azithromycin

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.

Maternal anaemia, preterm deliveries and low birth weight are common in Sub-Saharan Africa and contribute significantly to the ill-health of pregnant women and infants. The present study is based on the assumption that these adverse outcomes can be prevented by improved antimicrobial management of malaria and sexually transmitted infections (STI) among pregnant women. To test the hypothesis, a randomised clinical trial following Good Clinical Practice (GCP) is being carried out in Malawi, South-Eastern Africa.

A total of 1320 consenting women who present at a rural antenatal clinic after 14 but before 26 completed gestation weeks will be enrolled. One third of the women will receive antenatal care according to national recommendations, including regular visits to health centre, screening for pregnancy complications, haematinic and vitamin A supplementation and two doses of presumptive malaria treatment with sulfadoxine-pyrimethamine. Another third will receive otherwise the same care, but sulfadoxine-pyrimethamine treatment is given at monthly intervals. The final third receives standard antenatal care, sulfadoxine-pyrimethamine treatment at monthly intervals and two doses of presumptive STI treatment with azithromycin. Women are monitored throughout pregnancy and delivery and newborn growth will be followed up for five years.

The primary outcome measure is proportion of preterm births in the three study groups. Secondary maternal outcomes include anaemia and malaria parasitaemia during pregnancy, at delivery and at 1, 3, and 6 months after delivery, gestational weight gain and morbidity and STI prevalence after delivery. Secondary child outcomes consist of proportion of babies with low birth weight, mean birth weight, growth in infancy and childhood, incidence of malnutrition in infancy and childhood, and mortality. Additionally, information is collected on the development of malaria-specific humoral immunity in pregnancy and participant experiences from the study. Participant safety is systematically monitored throughout the intervention.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Malaria
  • Sexually Transmitted Diseases
  • Preterm Birth
  • Pregnancy
  • Drug: Sulfadoxine-pyrimethamine treatment twice during pregnancy

    Sulfadoxine-pyrimethamine, 3 tablets (each containing 500mg of sulfadoxine and 25mg of pyrimethamine), taken once at antenatal care enrolment (14.0-25.9 gestation weeks) and another time between 28.0 and 33.9 gestation weeks.

    2 placebo tablets for azithromycin taken at the same time points.

  • Drug: Sulfadoxine-pyrimethamine at 4-week intervals

    Sulfadoxine-pyrimethamine, 3 tablets (each containing 500mg of sulfadoxine and 25mg of pyrimethamine), taken once at antenatal care enrolment (14.0-25.9 gestation weeks) and then at 4 week intervals until 37.0 gestation weeks.

    2 placebo tablets for azithromycin taken once at antenatal care enrolment (14.0-25.9 gestation weeks) and another time between 28.0 and 33.9 gestation weeks.

  • Drug: Sulfadoxine-pyrimethamine every 4 weeks + azithromycin twice

    Sulfadoxine-pyrimethamine, 3 tablets (each containing 500mg of sulfadoxine and 25mg of pyrimethamine), taken once at antenatal care enrolment (14.0-25.9 gestation weeks) and then at 4 week intervals until 37.0 gestation weeks.

    2 azithromycin tablets (each 500 mg) taken once at antenatal care enrolment (14.0-25.9 gestation weeks) and another time between 28.0 and 33.9 gestation weeks.

  • Placebo Comparator: Control
    Standard antenatal care as described in intervention
    Intervention: Drug: Sulfadoxine-pyrimethamine treatment twice during pregnancy
  • Experimental: Monthly SP
    Standard antenatal care + monthly intermittent presumptive treatment of malaria with sulfadoxine pyrimethamine, as described in intervention
    Intervention: Drug: Sulfadoxine-pyrimethamine at 4-week intervals
  • Experimental: AZI-SP
    Standard antenatal care + monthly intermittent presumptive treatment of malaria with sulfadoxine pyrimethamine + two presumptive treatments of sexually transmitted infections and malaria with azithromycin, as described in intervention
    Intervention: Drug: Sulfadoxine-pyrimethamine every 4 weeks + azithromycin twice

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1320
March 2012
May 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Signed informed consent
  • Age >= 15 years
  • Ultrasound confirmed pregnancy
  • Quickening
  • Foetal age 14-26 gestation weeks
  • Maternal availability for follow-up during the entire study period

Exclusion Criteria:

  • Known maternal tuberculosis, diabetes, kidney disease or liver disease
  • Any severe acute illness warranting hospital referral at enrollment visit
  • Mental disorder that may affect comprehension of the study or success of follow-up
  • Twin pregnancy
  • Pregnancy complications evident at enrollment visit (moderate to severe oedema, blood hemoglobin [Hb] concentration < 50 g/l, systolic blood pressure [BP] > 160 mmHg or diastolic BP > 100 mmHg)
  • Prior receipt of azithromycin during this pregnancy
  • Receipt of sulfadoxine and pyrimethamine within 28 days of enrollment
  • Known allergy to drugs containing sulfonamides, macrolides or pyrimethamine
  • History of anaphylaxis
  • History of any serious allergic reaction to any substance, requiring emergency medical care
  • Concurrent participation in any other clinical trial
Female
15 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Malawi
 
NCT00131235
SA-179787-1
Yes
Per Ashorn, University of Tampere
University of Tampere
  • Academy of Finland
  • Foundation for Paediatric Research, Finland
Study Director: Per Ashorn, MD, PhD University of Tampere, Medical School
Principal Investigator: Kenneth M Maleta, MBBS, PhD University of Malawi College of Medicine
Principal Investigator: Teija Kulmala, MD, PhD University of Tampere, School of Public Health
University of Tampere
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP