Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131235
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-29
First Post:
2005-08-16
Brief Title:
Gestational Sulfadoxine-pyrimethamine and Azithromycin Treatment to Prevent Preterm Birth
Sponsor:
Tampere University
Organization:
Tampere University
Study Overview
Official Title:
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 foetusnewborn
Detailed Description:
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
There have been two edits two the trial protocol since the original approval In the first one there was an amendment to follow child growth and mortality until and child development at 5 years of age with visits at 1 3 6 9 12 15 18 21 24 30 36 48 and 60 months In the second amendment there was an addition to monitor child antropometrics physical mental and social health at and mortality by 10-12 years of age
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
There have been two edits two the trial protocol since the original approval In the first one there was an amendment to follow child growth and mortality until and child development at 5 years of age with visits at 1 3 6 9 12 15 18 21 24 30 36 48 and 60 months In the second amendment there was an addition to monitor child antropometrics physical mental and social health at and mortality by 10-12 years of age
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None