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Malaria in Pregnancy clinical trials

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NCT ID: NCT03998839 Completed - Clinical trials for Malaria in Pregnancy

TIPTOP Sulfadoxine-pyrimethamine (SP) Drug Resistance Study

TIPTOP-DRS
Start date: March 5, 2018
Phase:
Study type: Observational

The main objective of this study is to monitor SP resistance via molecular markers in the context of the TIPTOP project implementation of community distributed SP for women during pregnancy. The specific objective is to detect trends over time in the proportion of symptomatic children with a positive rapid diagnostic test (RDT) residing in the areas where C-IPTp is implemented who carry parasites with dhfr/dhps mutations compared to those in control areas with no community SP distribution.

NCT ID: NCT03944317 Not yet recruiting - Pregnancy Clinical Trials

Azithromycin (AZ) and Sulphadoxine-pyrimethamine (SP) for Malaria Prevention in Pregnant Women (IPT-AZ/IPT-SP)

Start date: June 1, 2019
Phase: N/A
Study type: Interventional

AZITHROMYCIN VERSUS SULPHADOXINE‑PYRIMETHAMINE FOR PROPHYLAXIS AGAINST MALARIA IN PREGNANCY IN OWO, SOUIHWESTERN NIGERIA: A RANDOMISED CONTROLLED TRIAL OBJECTIVE: This study is to compare the efficacy of Azithromycin versus sulphadoxine‑pyrimethamine as options of chemoprophylaxis against malaria in pregnancy. METHOD: This is a randomized controlled trial with parallel assignment that will be conducted in the Obstetrics and Gynaecology department of the Federal Medical Centre. One hundred and sixty four (164) pregnant women who are eligible will be randomly allocated to 2 groups (A and B) of 84 each, using computer generated random numbers. Group A will receive sulfadoxine-pyrimethamine for malaria prophylaxis while Group B will receive azithromycin. All other aspects of antenatal care till delivery will be the same for all the women recruited. Maternal venous blood samples for malaria parasitaemia will be collected on recruitment and repeated at follow-up visits at any gestation there are symptoms of malaria; maternal peripheral blood film, placental and cord blood samples will be collected at delivery. All data will be documented in the data collection sheet. The results obtained will be subjected to statistical analysis using statistical package for social sciences (SPSS) version 21, Armonk, NY:IBM. The level of significance will be set at 5%. Outcomes will be compared across groups using Chi-square.

NCT ID: NCT03754322 Recruiting - Malaria Clinical Trials

LAMP Detection of Malaria in PREGnancy (LAMPREG) Trial

LAMPREG
Start date: June 18, 2021
Phase: N/A
Study type: Interventional

Objective: The aim of this study is to evaluate the impact of enhanced malaria cases detection using molecular testing (LAMP) on maternal and infant morbidity and mortality in a prospective study design. A pragmatic randomized control diagnostic trial will be conducted from October 2020 until March 1 2022 in pregnant mothers at sites in Ethiopia. Both symptomatic and asymptomatic first and early second trimester pregnant women will be included in the study and individually randomized to either standard of care or enhanced cased detection arms using LAMP for malaria. Women (n=2583) will be enrolled during a seven-month period encompassing the peak transmission seasons and then followed until delivery. In the standard of care arm, venous blood sample will be collected from each study participant and the presence of Plasmodium infection will be diagnosed by microscopy in symptomatic patients. Pregnant women who test positive for malaria will be referred and treated for malaria with quinine or artemisinin combination therapies (ACTs) as per national guidelines. In the intervention arm, mothers who are symptomatic or asymptomatic will be tested by a commercially available CE-approved LAMP malaria test and microscopy/RDT for malaria at each clinic visit and treated if positive by any test. Pregnant mothers who require treatment will be referred and treated with either quinine or artemisinin combination therapy (ACTs) as per national guidelines. The primary outcome is the proportion of deliveries with low birth weight based on WHO definition, with secondary outcomes of:(i)absolute birth weight; (ii) maternal hemoglobin;(ii) neonatal hemoglobin at birth;(iv) neonatal mortality; (v) stillbirth; and (vi) prematurity in each arm of the study.

NCT ID: NCT03600844 Completed - Clinical trials for Malaria in Pregnancy

Evaluating the Effects of Community Delivery of Malaria Intermittent Preventive Treatment on Pregnant Women and Babies

TIPTOP
Start date: April 2, 2018
Phase: N/A
Study type: Interventional

This study evaluates the effectiveness of community delivery of sulfadoxine-pyrimetamine (SP) for intermittent preventive treatment of malaria in pregnancy (IPTp) in increasing the coverage of IPTp among pregnant women in selected districts in Democratic Republic of Congo (DRC), Madagascar, Mozambique and Nigeria, compared to comparison districts where SP for IPTp is distributed as usual in facilities through routine antenatal care (ANC).

NCT ID: NCT03508349 Completed - Clinical trials for Malaria in Pregnancy

Routine Antenatal Care Versus Screening and Treatment of Malaria in Pregnancy in Rwanda

Start date: September 5, 2016
Phase: N/A
Study type: Interventional

The main aim of this study is to test the primary hypothesis that the addition of intermittent screening and treatment of malaria in pregnant women (ISTp) who receive routine antenatal care (ANC) in health facilities in high malaria transmission areas in Rwanda will reduce malaria prevalence among pregnant women when compared to routine antenatal cares services alone.

NCT ID: NCT03376217 Completed - Clinical trials for Malaria in Pregnancy

Assessing the Effectiveness of Community Delivery of Intermittent Preventive Treatment in Pregnancy (IPTp) in Malawi

Start date: December 1, 2017
Phase: N/A
Study type: Interventional

The overall aim of the study is to learn whether utilization of Health Surveillance Assistants (HSAs) for delivery of intermittent preventive treatment of malaria in pregnant women (IPTp) can increase coverage of three or more IPTp doses compared to IPTp delivery only at antenatal clinics (ANC), while at the same time improve or maintain ANC attendance. This will be a cluster randomized trial, including a total of 20 health facilities (HF) which will be randomly assigned to either the intervention (10) or non-intervention group (10); all HSAs affiliated with a HF will be in the same group.

NCT ID: NCT03208179 Completed - Pregnancy Clinical Trials

Improving PRegnancy Outcomes With Intermittent preVEntive Treatment in Africa

IMPROVE
Start date: March 29, 2018
Phase: Phase 3
Study type: Interventional

This study evaluates the efficacy and safety of monthly intermittent preventive treatment using dihydroartemisinin piperaquine (DP) alone or in combination with azithromycin (AZ) compared to sulphadoxine-pyrimethamine (SP) for the prevention of malaria in pregnant women in the second and third trimester.

NCT ID: NCT01746199 Completed - HIV Infection Clinical Trials

Efficacy of Antifolates Against Malaria in HIV-infected Pregnant Women and the Emergence of Induced Resistance in Plasmodium Falciparum

MACOMBA
Start date: December 2013
Phase: Phase 3
Study type: Interventional

Given the resistance emergence of malaria in pregnant women receiving intermittent preventive treatment with sulfadoxine-pyrimethamine (IPT-SP) and the burden of this infection among pregnant women infected by HIV it is urgent to seek a more effective alternative treatment to optimize the prevention of malaria. Cotrimoxazole (CTM), actually administered daily as a prophylactic mean to opportunistic infections for HIV infected patients, showed encouraging results in preventing malaria in pregnant women. However, these results must be confirmed by randomized trials, particularly in pregnant women. The main objective of this clinical trial is to compare the efficacy of cotrimoxazole (CTM), administered once daily with IPT-SP (3 curative doses spaced one month) on placental parasitaemia in pregnant women infected with HIV and cluster of differentiation 4 (CD4) > 350 cells/mm3. The main hypothesis is based on the premise that cotrimoxazole is more effective than IPT-SP for placental parasitaemia. This might be due to the higher plasma concentration of cotrimoxazole attained with daily doses. If this hypothesis is proven, cotrimoxazole could be recommended as prophylaxis for HIV-positive pregnant women, whatever their CD4+ cell count. In this study, the investigators will also test the hypothesis that the strains of Plasmodium falciparum isolated from HIV-positive pregnant women express more dhfr and dhps resistance markers.

NCT ID: NCT01555255 Active, not recruiting - Malaria Clinical Trials

Malaria Rapid Diagnostic Tests (RDTs) in Pregnancy: Detection of Placental Malaria

Start date: November 2010
Phase: N/A
Study type: Observational

This study seeks to determine whether screening pregnant women for malaria with malaria rapid diagnostic tests (RDTs) may detect placental infection and predict risk of poor birth outcomes due to malaria in areas of varied malaria transmission in Africa.

NCT ID: NCT01136850 Completed - Anaemia Clinical Trials

Intermittent Preventive Treatment With Azithromycin-containing Regimens in Pregnant Women in Papua New Guinea

IPTp in PNG
Start date: November 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether repeated courses of sulphadoxine-pyrimethamine (SP) in combination with azithromycin given at Antenatal Clinic, leads to lower rates of low birth weight deliveries (<2.5 kg) among Papua New Guinean women, than the current standard treatment of SP and chloroquine.