IPT of Malaria With SP in Different Zones of Drug Resistance in Rwanda

NCT00372632 | Completed Phase 4

• 1 other identifier: 05 34 5 520
• Study Type: interventional
• Target: 1,717
• Locations: 1 country
• Sites: 1

Brief Summary

The present study will address the question whether the use of IPT using SP in pregnancy is efficacious in Rwanda, where it is going to be used for the first time, in areas with high levels of SP resistance. While the implementation of the new policy will take place in areas at low SP resistance level, where we expect pregnant women and newborns to benefit from it, it is of paramount importance to clarify which is the real impact of IPT/SPin areas of high SP drug resistance and at what level of SP resistance this strategy is still efficacious. As bed nets are a part of the actual control strategy of malaria in pregnancy all women will receive a bed net at enrolment

Conditions

Non HIV Infected Pregnant Women

Keywords

Pregnancy malaria prevention

Outcome Measures

Primary Outcomes (1)

• malaria infection will be defined as the presence of asexual stage parasites on thick smears made with maternal side placental blood and Maternal peripheral blood

  maternal placental blood at delivery; maternal peripheral blood at monthly visits between 16 weeks of gestation and delivery

Secondary Outcomes (10)

• LBW = birth weight <2,500 grams

  at delivery

• Premature delivery = delivery prior to 37 weeks gestation

  at delivery

• Spontaneous miscarriage = any spontaneous abortion before the end of gestation

  at delivery

• Stillbirth

  at delivery

• Cord blood parasitaemia = presence of asexual stage parasites in thick smears

  at delivery

Study Arms (2)

placebo

PLACEBO COMPARATOR

Drug: placebo

sulfadoxine-pyrimethamine

EXPERIMENTAL

Drug: Sulfadoxine-Pyrimethamine

Interventions

Sulfadoxine-Pyrimethamine DRUG

The intervention group receives 1500mg of sulfadoxine and 75mg of pyrimethamine at enrollment and in the third trimester.

Also known as: fansidar

sulfadoxine-pyrimethamine

placebo DRUG

The control group receives placebo similar in taste and appearance to to the experimental arm

placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women between 16-28 weeks of gestation;
• Residence within the catchment's area of the health facility;
• Willing to deliver at the health facility;
• Willing to ; adhere to all requirements of the study;
• Willing to provide written informed consent;
• Aged 21 years and above

You may not qualify if:

• Severe anemia (Hb \< 6 g/dL)
• History of allergic reactions to sulfa drugs;
• Taking other sulfa drugs as CTX;
• History of known pregnancy complications (e.g. breech presentation, severe pre-eclampsia, prior caesarian section);
• History or presence of major illnesses likely to influence pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis, prior to randomization;
• Any significant illness that requires hospitalization;
• Intent to move out of the study catchment's area before delivery or deliver at relative's home out of the catchment's area;
• Prior enrollment in the study or concurrent enrollment in another study

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead

Study Sites (1)

Programme Nationale de Controle de Paludisms

Kigali, Rwanda

Location

MeSH Terms

Interventions

fanasil, pyrimethamine drug combination

Study Officials

• Umberto D'Alessandro, MD,MSc, PHD

  Institute of Tropical Medicine Antwerp

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 5, 2006
• First Posted: September 7, 2006
• Study Start: December 1, 2005
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: September 14, 2010

Record last verified: 2010-09

Locations

RW (1)