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A randomized placebo-controlled trial of intermittent preventive treatment in pregnant women in the context of insecticide treated nets delivered through the antenatal clinic.

Menéndez C, Bardají A, Sigauque B, Romagosa C, Sanz S, Serra-Casas E, Macete E, Berenguera A, David C, Dobaño C, Naniche D, Mayor A, Ordi J, Mandomando I, Aponte JJ, Mabunda S, Alonso PL - PLoS ONE (2008)

Bottom Line: Two-dose SP was safe and well tolerated, but was not associated with reductions in anaemia prevalence at delivery (RR, 0.92 [95% CI, 0.79-1.08]), low birth weight (RR, 0.99 [95% CI, 0.70-1.39]), or overall placental infection (p = 0.964).These effects were not modified by gravidity or HIV status.Two-dose SP was associated with a reduction in some indicators, but these were not translated to significant improvement in other maternal or birth outcomes.

View Article: PubMed Central - PubMed

Affiliation: Barcelona Center for International Health Research (CRESIB) and Department of Pathology Hospital Clinic, Institut d'Investigacions Biomedicas August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain. menendez@clinic.ub.es

ABSTRACT

Background: Current recommendations to prevent malaria in African pregnant women rely on insecticide treated nets (ITNs) and intermittent preventive treatment (IPTp). However, there is no information on the safety and efficacy of their combined use.

Methods: 1030 pregnant Mozambican women of all gravidities received a long-lasting ITN during antenatal clinic (ANC) visits and, irrespective of HIV status, were enrolled in a randomised, double blind, placebo-controlled trial, to assess the safety and efficacy of 2-dose sulphadoxine-pyrimethamine (SP). The main outcome was the reduction in low birth weight.

Findings: Two-dose SP was safe and well tolerated, but was not associated with reductions in anaemia prevalence at delivery (RR, 0.92 [95% CI, 0.79-1.08]), low birth weight (RR, 0.99 [95% CI, 0.70-1.39]), or overall placental infection (p = 0.964). However, the SP group showed a 40% reduction (95% CI, 7.40-61.20]; p = 0.020) in the incidence of clinical malaria during pregnancy, and reductions in the prevalence of peripheral parasitaemia (7.10% vs 15.15%) (p<0.001), and of actively infected placentas (7.04% vs 13.60%) (p = 0.002). There was a reduction in severe anaemia at delivery of borderline statistical significance (p = 0.055). These effects were not modified by gravidity or HIV status. Reported ITN's use was more than 90% in both groups.

Conclusions: Two-dose SP was associated with a reduction in some indicators, but these were not translated to significant improvement in other maternal or birth outcomes. The use of ITNs during pregnancy may reduce the need to administer IPTp. ITNs should be part of the ANC package in sub-Saharan Africa.

Trial registration: ClinicalTrials.gov NCT00209781.

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Related in: MedlinePlus

Trial profileThere were 3 and 7 twins births in the SP and placebo groups respectively. There was one triplet birth in the SP Group.* sulphadoxine-pyrimethamine ** 1 woman in the SP group and 2 in the placebo group had a miscarriage before receiving dose 1
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pone-0001934-g001: Trial profileThere were 3 and 7 twins births in the SP and placebo groups respectively. There was one triplet birth in the SP Group.* sulphadoxine-pyrimethamine ** 1 woman in the SP group and 2 in the placebo group had a miscarriage before receiving dose 1

Mentions: Figure 1 shows the trial profile and table 1 shows the baseline characteristics of participants. Reported ITN use at the end of pregnancy was similar between the groups (90.38% and 92.52% in the SP and placebo groups, respectively, p = 0.324). 85% of the women had an HIV test and 23.6% were HIV positive. Mean gestational age was 23.21 (SD 3.44) weeks at the first IPTp SP/placebo dose and 28.34 (SD 3.65) weeks at the second IPTp dose. Mean time between first and second IPTp SP/placebo dose was 36.53 (SD 11.55) days, and mean time between last dose and delivery was 76.91 (SD 31.19) days.


A randomized placebo-controlled trial of intermittent preventive treatment in pregnant women in the context of insecticide treated nets delivered through the antenatal clinic.

Menéndez C, Bardají A, Sigauque B, Romagosa C, Sanz S, Serra-Casas E, Macete E, Berenguera A, David C, Dobaño C, Naniche D, Mayor A, Ordi J, Mandomando I, Aponte JJ, Mabunda S, Alonso PL - PLoS ONE (2008)

Trial profileThere were 3 and 7 twins births in the SP and placebo groups respectively. There was one triplet birth in the SP Group.* sulphadoxine-pyrimethamine ** 1 woman in the SP group and 2 in the placebo group had a miscarriage before receiving dose 1
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2277457&req=5

pone-0001934-g001: Trial profileThere were 3 and 7 twins births in the SP and placebo groups respectively. There was one triplet birth in the SP Group.* sulphadoxine-pyrimethamine ** 1 woman in the SP group and 2 in the placebo group had a miscarriage before receiving dose 1
Mentions: Figure 1 shows the trial profile and table 1 shows the baseline characteristics of participants. Reported ITN use at the end of pregnancy was similar between the groups (90.38% and 92.52% in the SP and placebo groups, respectively, p = 0.324). 85% of the women had an HIV test and 23.6% were HIV positive. Mean gestational age was 23.21 (SD 3.44) weeks at the first IPTp SP/placebo dose and 28.34 (SD 3.65) weeks at the second IPTp dose. Mean time between first and second IPTp SP/placebo dose was 36.53 (SD 11.55) days, and mean time between last dose and delivery was 76.91 (SD 31.19) days.

Bottom Line: Two-dose SP was safe and well tolerated, but was not associated with reductions in anaemia prevalence at delivery (RR, 0.92 [95% CI, 0.79-1.08]), low birth weight (RR, 0.99 [95% CI, 0.70-1.39]), or overall placental infection (p = 0.964).These effects were not modified by gravidity or HIV status.Two-dose SP was associated with a reduction in some indicators, but these were not translated to significant improvement in other maternal or birth outcomes.

View Article: PubMed Central - PubMed

Affiliation: Barcelona Center for International Health Research (CRESIB) and Department of Pathology Hospital Clinic, Institut d'Investigacions Biomedicas August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain. menendez@clinic.ub.es

ABSTRACT

Background: Current recommendations to prevent malaria in African pregnant women rely on insecticide treated nets (ITNs) and intermittent preventive treatment (IPTp). However, there is no information on the safety and efficacy of their combined use.

Methods: 1030 pregnant Mozambican women of all gravidities received a long-lasting ITN during antenatal clinic (ANC) visits and, irrespective of HIV status, were enrolled in a randomised, double blind, placebo-controlled trial, to assess the safety and efficacy of 2-dose sulphadoxine-pyrimethamine (SP). The main outcome was the reduction in low birth weight.

Findings: Two-dose SP was safe and well tolerated, but was not associated with reductions in anaemia prevalence at delivery (RR, 0.92 [95% CI, 0.79-1.08]), low birth weight (RR, 0.99 [95% CI, 0.70-1.39]), or overall placental infection (p = 0.964). However, the SP group showed a 40% reduction (95% CI, 7.40-61.20]; p = 0.020) in the incidence of clinical malaria during pregnancy, and reductions in the prevalence of peripheral parasitaemia (7.10% vs 15.15%) (p<0.001), and of actively infected placentas (7.04% vs 13.60%) (p = 0.002). There was a reduction in severe anaemia at delivery of borderline statistical significance (p = 0.055). These effects were not modified by gravidity or HIV status. Reported ITN's use was more than 90% in both groups.

Conclusions: Two-dose SP was associated with a reduction in some indicators, but these were not translated to significant improvement in other maternal or birth outcomes. The use of ITNs during pregnancy may reduce the need to administer IPTp. ITNs should be part of the ANC package in sub-Saharan Africa.

Trial registration: ClinicalTrials.gov NCT00209781.

Show MeSH
Related in: MedlinePlus