Prevention of P. Vivax Malaria During Pregnancy in Bolivia
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Purpose
The purpose of this study is to determine which, between weekly prophylaxis or malaria attack treatment, both by chloroquine, is the most appropriate way to protect women and foetus from P. vivax malaria infection during pregnancy.
| Condition | Intervention | Phase |
|---|---|---|
|
Malaria |
Drug: Chloroquine profilaxis |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Prevention of P. Vivax Malaria During Pregnancy: Effects on Mother and Child Health in Santa Cruz, Bolivia. Open, Multicentric, Randomized Clinical Trial, Comparing Prophylaxis Once a Week to Malaria Attack Treatment, Both by Chloroquine. |
- Incidence of women presenting a malaria attack during pregnancy [ Time Frame: two years ] [ Designated as safety issue: Yes ]
- proportions of mothers with placental plasmodial infection [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- proportions of mothers with moderate to severe anaemia (<8g/dl) at delivery [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- maternal haemoglobin rate at delivery [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- proportions of women with parasitaemia during pregnancy and at delivery [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- mean parasites densities of women with parasitaemia during pregnancy and at delivery [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- proportions of children with low birthweight (<2,500 grams) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- mean birthweight [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- proportions of preterm deliveries [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 0 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | November 2007 |
| Estimated Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Chloroquine profilaxis
Prevention: chloroquine profilaxis Prevention of malaria attacks with chloroquine profilaxis taken once a week |
Drug: Chloroquine profilaxis
Prevention: Give a profilaxis with chloroquine once a week to prevent Plasmodium vivax malaria attacks and to prevent harmfull effect on birth outcomes Other Name: prevention of plasmodium vivax malaria harmfull effects on birth outcomes
|
|
No Intervention: No prevention
Treatment of malaria attack with chloroquine when they occur
|
Detailed Description:
It has been demonstrated that malaria is responsible for anaemia during pregnancy and reduces birth weight among newborns. In Bolivia, malaria is mostly caused by P. vivax. Maternal and foetal consequences of P. vivax infections have been poorly investigated until now, over all in South America. In fact, recommendations for the protection of pregnant women from malaria in Bolivia have not been clearly established. Prophylaxis by chloroquine is still recommended in other continents than Africa, mainly because chloroquine resistances are still uncommon in P. vivax species. The alternative way to protect women during pregnancy is to treat malaria attacks during antenatal visits. For this purpose, we will realize a study in order to assess the most appropriate way to protect women and foetus from malaria infection, i.e. weekly prophylaxis or mild malaria attack treatment, both by chloroquine. By realizing a randomized and multicentric clinical trial on 800 women in each group, we will compare the impact on maternal malaria attack incidence rates, on proportions of mothers with anaemia, on low-birth weight and on positive parasitaemias during pregnancy and at delivery, of weekly prophylaxis and mild malaria attack diagnosis and treatment. The study will be undertaken during 18 months in the region of Santa Cruz and will give important information to the Bolivian Ministry of Health for establishing national recommendations.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Pregnancy between 4 to 36 weeks of gestation
- Intention to deliver at the maternity clinics
- Residence near the maternity clinics
- Written informed consent (parents or tutors if aged<18 years)
Exclusion Criteria:
- Pregnancy prior to 4 weeks or after 36 weeks of gestation
- Allergy to chloroquine
- Clinical signs of hepatic or renal alteration
- Inability to take drugs by oral route
- Presence of effective uterine contractions
Contacts and Locations| Study Director: | Michel Cot, MD-PhD | Institut de Recherche pour le Developpement |
| Study Director: | Laurent Brutus, MD-MSc | Institut de Recherche pour le Développement, IRD, Bolivia |
| Principal Investigator: | Agnès Le Port, MSc | Institut de Recherche pour le Développement, IRD, Bolivia |
More Information
No publications provided
| Responsible Party: | Bernadette Murgue, administrative responsible for IRD, Institut de Recherche pour le Developpement |
| ClinicalTrials.gov Identifier: | NCT00290420 History of Changes |
| Other Study ID Numbers: | IRD/Prevmal/Bol/06 |
| Study First Received: | February 9, 2006 |
| Last Updated: | May 21, 2013 |
| Health Authority: | France: Ministère de l'Enseignement supérieur et de la Recherche |
Keywords provided by Institut de Recherche pour le Developpement:
|
malaria Plasmodium vivax pregnancy chemoprophylaxis |
Additional relevant MeSH terms:
|
Malaria Malaria, Vivax Protozoan Infections Parasitic Diseases Chloroquine Chloroquine diphosphate Amebicides Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimalarials |
Antirheumatic Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Filaricides Antinematodal Agents Anthelmintics Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 18, 2013