Efficacy and Safety of Sulphadoxine-pyrimethamine and Amodiaquine in Ghanaian Pregnant Women
|ClinicalTrials.gov Identifier: NCT00131703|
Recruitment Status : Completed
First Posted : August 19, 2005
Last Update Posted : January 12, 2017
|First Submitted Date ICMJE||August 18, 2005|
|First Posted Date ICMJE||August 19, 2005|
|Last Update Posted Date||January 12, 2017|
|Start Date ICMJE||March 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE
|Change History||Complete list of historical versions of study NCT00131703 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Efficacy and Safety of Sulphadoxine-pyrimethamine and Amodiaquine in Ghanaian Pregnant Women|
|Official Title ICMJE||A Randomised Double Blind Clinical Trial of Amodiaquine (AQ) and Sulphadoxine-pyrimethamine (SP) Used Singly and in Combination (AQ+SP) Compared With Chloroquine (CQ) in the Treatment of Falciparum Malaria Infection in Pregnancy|
|Brief Summary||Malaria in pregnancy is potentially fatal to both the mother and the foetus particularly in the primigravidae. Implementation of appropriate control and preventive measures is challenged by the fact that malaria infection in pregnancy is often asymptomatic and parasitized red blood cells sequestrated in the placental microcirculation may not be detectable in the peripheral blood. In addition, the widespread prevalence of parasites resistant to chloroquine and sulphadoxine-pyrimethamine (SP) and, the safety concerns about newer antimalarials, poverty and inadequate supply have made antimalarial treatment options available to pregnant women very limited. These have necessitated an urgent search for alternative safe and efficacious treatment options for pregnant women. The objective of this study is to assess the efficacy, safety and tolerability of four antimalarial treatment options in rural Ghana within a programme setting.|
To determine the effect of AQ, SP and the AQ+SP combination compared with CQ treatment on the prevalence of peripheral parasitaemia on days 14 and 28 post treatment.
Study location and population:
The study was carried out at the St. Theresa's Hospital in the Nkoranza district of the Brong Ahafo Region of Ghana. The St. Theresa's hospital is a general district hospital. It has a bed capacity of 80 and provides all basic medical services including adult medicine, paediatrics, surgery and obstetrics and gynaecology. The study enrolled pregnant women of all parities attending the St. Theresa's Hospital's antenatal clinic with a gestational age of 16 weeks and above between March 2003 and September 2004.
Antennal screening and enrolment:
All pregnant women who attended antenatal clinics were screened for malaria antigens with OptiMAL dipsticks. Those with a positive antigen test were considered eligible, and after informed consent had been obtained from them 5mls of venous blood was drawn from an antecubital vein for baseline measurements of haemoglobin, white blood cell counts (total and differential), bilirubin, alanine aminotransferase, aspartate aminotransferase and gamma-glutamyl transferase and for making filter paper blood spots. Women were then assessed clinically and obstetrically with the view to enrolling them into the study. Pregnancy viability and gestational age were confirmed with ultrasound scanning by the study clinician or the principal investigator. Pregnant women with positive malaria antigen tests confirmed microscopically were randomised into four treatment arms if they satisfied all inclusion criteria.
Field workers visited the study women in their homes following the initial supervised drug administration at the antenatal clinic on post treatment days 3, 7, 14 and 28 and performed the following routines.
Subsequently, pregnant women were seen at the antenatal clinic monthly and, for those with 32 weeks and above of gestation fortnightly. At these visits, they were actively screened for peripheral parasitaemia using OptiMAL dipstick test. At any time before delivery if the test was negative, the woman remained on daily haematinics. If women who were already enrolled had positive antigen test confirmed by microscopy, they received another course of the treatment they were initially assigned to. Women were enrolled in the study only for the first episode of malaria detected during the antenatal visit. At delivery, midwives recorded birth weights and any stillbirths, perinatal deaths or congenital abnormalities. They also made slides from peripheral, placental and cord blood and sampled maternal blood for haemoglobin measurements. Any record of a congenital deformity was verified and confirmed by a clinician. The women and their babies were visited at home at six weeks post delivery to record any neonatal adverse events such as deaths or severe morbidity.
1. Prevalence of parasitaemia on days 14 and 28 post treatment.
This was based on the assumption of a 28-day parasitological clearance of 90% for AQ, SP and the AQ+SP combination, and 78% for chloroquine (α = 5% power = 90%). Allowing for a 15% loss to follow-up, 225 pregnant women were recruited into each of the 4 treatment arms of the study giving a total study size of 900 pregnant women.
Data and safety monitoring board:
A data and safety monitoring board (DSMB) was constituted for the project. The board was responsible for:
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Study Arms||Not Provided|
|Publications *||Tagbor H, Bruce J, Browne E, Randal A, Greenwood B, Chandramohan D. Efficacy, safety, and tolerability of amodiaquine plus sulphadoxine-pyrimethamine used alone or in combination for malaria treatment in pregnancy: a randomised trial. Lancet. 2006 Oct 14;368(9544):1349-56.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Completion Date||March 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||Child, Adult, Senior|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Not Provided|
|Removed Location Countries|
|NCT Number ICMJE||NCT00131703|
|Other Study ID Numbers ICMJE||ITCR5092|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Brian Greenwood, London School of Hygiene and Tropical Medicine|
|Study Sponsor ICMJE||London School of Hygiene and Tropical Medicine|
|Collaborators ICMJE||Ministry of Health, Ghana|
|PRS Account||London School of Hygiene and Tropical Medicine|
|Verification Date||January 2017|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP