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

Non HIV Infected Pregnant Women Clinical Trial

Official title:

Intermittent Preventive Treatment of Malaria With Sulfadoxine-Pyrimethamine in Different Zones of Drug Resistance in Rwanda

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00372632
• Other study ID #: 05 34 5 520
• Status: Completed
• Phase: Phase 4
• First received: September 5, 2006
• Last updated: September 12, 2010
• Start date: December 2005
• Est. completion date: April 2008

Study information

• Verified date: September 2010
• Source: Institute of Tropical Medicine, Belgium
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review BoardRwanda: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Description:

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.

This will be a randomized blinded placebo controlled trial: women in the 16-28th week of gestation will be offered enrolment into the study and randomized to receive IPT/SP regimen or placebo once during the second and once in the third trimesters.

The study will be conducted in Mashesha (estimated SP drug resistance 20%, 12% in 2000), Kicukiro (40% SP resistance) and Rukara (60% SP resistance). In each of these sites there are about 1000 deliveries per year. According to DHMT data, over 75% of pregnant women attend antenatal clinics, usually booking between 15 and 25 weeks of gestation. Based on this study we expect to find placental malaria prevalence over 50% in all sites.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1717
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Pregnant women between 16-28 weeks of gestation;

2. Residence within the catchment's area of the health facility;

3. Willing to deliver at the health facility;

4. Willing to ; adhere to all requirements of the study;

5. Willing to provide written informed consent;

6. Aged 21 years and above

Exclusion Criteria:

1. Severe anemia (Hb < 6 g/dL)

2. History of allergic reactions to sulfa drugs;

3. Taking other sulfa drugs as CTX;

4. History of known pregnancy complications (e.g. breech presentation, severe pre-eclampsia, prior caesarian section);

5. 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;

6. Any significant illness that requires hospitalization;

7. Intent to move out of the study catchment's area before delivery or deliver at relative's home out of the catchment's area;

8. Prior enrollment in the study or concurrent enrollment in another study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Non HIV Infected Pregnant Women

Intervention

Drug:
• Sulfadoxine-Pyrimethamine
The intervention group receives 1500mg of sulfadoxine and 75mg of pyrimethamine at enrollment and in the third trimester.
• placebo
The control group receives placebo similar in taste and appearance to to the experimental arm

Locations

Country	Name	City	State
Rwanda	Programme Nationale de Controle de Paludisms	Kigali

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Tropical Medicine, Belgium

Country where clinical trial is conducted

Rwanda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	LBW = birth weight <2,500 grams		at delivery	No
Secondary	Premature delivery = delivery prior to 37 weeks gestation		at delivery	No
Secondary	Spontaneous miscarriage = any spontaneous abortion before the end of gestation		at delivery	No
Secondary	Stillbirth		at delivery	No
Secondary	Cord blood parasitaemia = presence of asexual stage parasites in thick smears		at delivery	No
Secondary	Neonatal death = infant death within the first 28 days of life		7days and 6 weeks after delivery	No
Secondary	Maternal anemia = Hb <11.0 g/dL		at monthly visits between 16 weeks of gestation and delivery	No
Secondary	Maternal severe anemia = Hb <6 g/dL		at monthly visits between 16 weeks of gestation and delivery	No
Secondary	Symptomatic maternal malaria infection = axillary temperature 37.5°C and asexual parasitaemia		at monthly visits between 16 weeks of gestation and delivery	No
Secondary	Severe maternal adverse reactions to SP = severe cutaneous reactions (e.g., erythema multiform, Stevens-Johnson syndrome, or toxic epidermal necrolysis)		at monthly visits between 16 weeks of gestation and delivery plus at day 7 and week 6 after delivery	Yes