Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120809
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2005-07-12
Brief Title:
Intermittent Preventative Treatment With Sulfadoxine-Pyrimethamine in Gambian Multigravidae
Sponsor:
London School of Hygiene and Tropical Medicine
Organization:
London School of Hygiene and Tropical Medicine
Study Overview
Official Title:
A Randomised Placebo Controlled Trial of Intermittent Preventative Treatment With Sulfadoxine-pyrimethamine in Gambian Multigravidae
Status:
COMPLETED
Status Verified Date:
2017-01
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:
Malaria is particularly harmful during pregnancy causing anemia in the mother and low birth weight which in turn increases infant mortality Thus the World Health Organization WHO now recommends that all pregnant women who live in malaria endemic areas of Africa should receive sulfadoxine-pyrimethamine SP at monthly intervals during the second and third trimesters of pregnancy Malaria is especially severe during first pregnancies and the value of intermittent preventative treatment with SP during first pregnancies has been clearly shown However it is less certain whether multigravidae who are at less risk also benefit from intermittent preventative treatment with SP To investigate this a trial has been conducted in Gambian multigravidae who were given intermittent preventative treatment with SP or placebo during the second and third trimesters The prevalence of anemia six weeks after delivery low birth weight and poor outcome of pregnancy in women in each group were studied
Detailed Description:
Objective
The objective of this study was to determine whether intermittent preventative treatment IPTp with sulfadoxine-pyrimethamine SP reduced the prevalence of anemia and low birth weight in Gambian multigravidae
Study area
The study was carried out in 14 mother and child health MCH clinics situated on the north and south banks of the River Gambia near to the town of Farafenni in the centre of the country In this area malaria is highly seasonal with an entomological inoculation rate of 10 -50 infectious bites per year
Study population
All women who attended one of the study clinics during the trial period and who were multigravidae were asked if they wished to join the study If this was the case an initial screening questionnaire was administered to assess their suitability to do so Eligibility criteria were - a pregnancy of more than 15 weeks gestation a hemoglobin Hb concentration of more than 7 gdL absence of a history of sensitivity to sulfonamides and absence of any chronic underlying illness
Randomisation
If a woman met the eligibility criteria informed written consent was sought and if this was given the woman was formally recruited to the study and allocated a trial number and randomised to receive either SP or placebo Randomisation was done in blocks of 12 each field worker was assigned a number of blocks to ensure balanced recruitment between centers
Drug administration
Women were allocated to receive SP pyrimethamine 25 mg sulfadoxine 500 mgCosmos Pharmaceuticals Nairobi or matching placebo An initial dose of SP or placebo three tablets was given at the time of enrolment into the trial and at all subsequent visits to the antenatal clinic up to a maximum of four treatments All women were given iron and folic acid supplements as recommended by the Ministry of Health guidelines
Surveillance
Women were visited at home twice per week by a project field worker to assess their health and to encourage them to attend the ante-natal clinic at monthly intervals Women with a high risk of obstetric complications were encouraged to deliver in hospital but most women delivered at home
If a delivery occurred in hospital or a health center a finger prick blood sample was obtained and the birth weight was measured In the case of women who delivered at home the weight of the new born baby was measured within 5 days of delivery and a finger prick blood sample obtained for measurement of Hb concentration and preparation of blood films
Women were visited at home six weeks after delivery when an additional blood sample was obtained and one year later to investigate the health of their child
Laboratory methods
Hemoglobin concentration was measured using a Hemocue Hemocue AB Angelholm Sweden Thick blood films were stained with Giemsa and examined for malaria parasites Each slide was read by two microscopists If discrepant results were obtained the slide was read by a third microscopist and the majority view accepted
Trial end-points
The co-primary trial end-points were hemoglobin concentration at or shortly after birth and birthweight or weight of the baby shortly after birth
Sample size
To detect a 20 reduction in the estimated risk of severe anemia Hb 7 gdl among multigravidae estimated to be 30 in the control group with 80 power at the 5 level of significance and allowing for a 30 loss to follow-up it was calculated that a study with 1115 women in each arm was required To show a reduction in the proportion of low birthweight babies from the expected 18 in the control group to 12 in the SP group with 80 power it was estimated that 2 x 1538 women would be needed Thus the target sample size was 3000
Data management and analysis
All data were double entered and verified Prior to the breaking of the code the data base was locked and a copy given to the chair of the Data Safety Monitoring Board DSMB Statistical analysis was done using S-plus and STATA An analytical plan was prepared and approved by the DSMB before the code was broken
Trial oversight
The trial was monitored by a DSMB It was conducted in line with the requirements of Good Clinical Practice
The objective of this study was to determine whether intermittent preventative treatment IPTp with sulfadoxine-pyrimethamine SP reduced the prevalence of anemia and low birth weight in Gambian multigravidae
Study area
The study was carried out in 14 mother and child health MCH clinics situated on the north and south banks of the River Gambia near to the town of Farafenni in the centre of the country In this area malaria is highly seasonal with an entomological inoculation rate of 10 -50 infectious bites per year
Study population
All women who attended one of the study clinics during the trial period and who were multigravidae were asked if they wished to join the study If this was the case an initial screening questionnaire was administered to assess their suitability to do so Eligibility criteria were - a pregnancy of more than 15 weeks gestation a hemoglobin Hb concentration of more than 7 gdL absence of a history of sensitivity to sulfonamides and absence of any chronic underlying illness
Randomisation
If a woman met the eligibility criteria informed written consent was sought and if this was given the woman was formally recruited to the study and allocated a trial number and randomised to receive either SP or placebo Randomisation was done in blocks of 12 each field worker was assigned a number of blocks to ensure balanced recruitment between centers
Drug administration
Women were allocated to receive SP pyrimethamine 25 mg sulfadoxine 500 mgCosmos Pharmaceuticals Nairobi or matching placebo An initial dose of SP or placebo three tablets was given at the time of enrolment into the trial and at all subsequent visits to the antenatal clinic up to a maximum of four treatments All women were given iron and folic acid supplements as recommended by the Ministry of Health guidelines
Surveillance
Women were visited at home twice per week by a project field worker to assess their health and to encourage them to attend the ante-natal clinic at monthly intervals Women with a high risk of obstetric complications were encouraged to deliver in hospital but most women delivered at home
If a delivery occurred in hospital or a health center a finger prick blood sample was obtained and the birth weight was measured In the case of women who delivered at home the weight of the new born baby was measured within 5 days of delivery and a finger prick blood sample obtained for measurement of Hb concentration and preparation of blood films
Women were visited at home six weeks after delivery when an additional blood sample was obtained and one year later to investigate the health of their child
Laboratory methods
Hemoglobin concentration was measured using a Hemocue Hemocue AB Angelholm Sweden Thick blood films were stained with Giemsa and examined for malaria parasites Each slide was read by two microscopists If discrepant results were obtained the slide was read by a third microscopist and the majority view accepted
Trial end-points
The co-primary trial end-points were hemoglobin concentration at or shortly after birth and birthweight or weight of the baby shortly after birth
Sample size
To detect a 20 reduction in the estimated risk of severe anemia Hb 7 gdl among multigravidae estimated to be 30 in the control group with 80 power at the 5 level of significance and allowing for a 30 loss to follow-up it was calculated that a study with 1115 women in each arm was required To show a reduction in the proportion of low birthweight babies from the expected 18 in the control group to 12 in the SP group with 80 power it was estimated that 2 x 1538 women would be needed Thus the target sample size was 3000
Data management and analysis
All data were double entered and verified Prior to the breaking of the code the data base was locked and a copy given to the chair of the Data Safety Monitoring Board DSMB Statistical analysis was done using S-plus and STATA An analytical plan was prepared and approved by the DSMB before the code was broken
Trial oversight
The trial was monitored by a DSMB It was conducted in line with the requirements of Good Clinical Practice
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