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Randomized Controlled Trial
. 2023 Jul 5;77(1):127-134.
doi: 10.1093/cid/ciad128.

Effectiveness of Intermittent Screening and Treatment of Malaria in Pregnancy on Maternal and Birth Outcomes in Selected Districts in Rwanda: A Cluster Randomized Controlled Trial

Aline Uwimana  1 , Reena Sethi  2 , Monique Murindahabi  1 , Celestin Ntirandeka  3 , Emily Piercefield  4 , Noella Umulisa  3 , Andrew Abram  5 , Erin Eckert  6 , Kaendi Munguti  7 , David Sullivan  8 , Didier Uyizeye  1 , Aimable Mbituyumuremyi  1 , Julie R Gutman  9
Affiliations
Randomized Controlled Trial

Effectiveness of Intermittent Screening and Treatment of Malaria in Pregnancy on Maternal and Birth Outcomes in Selected Districts in Rwanda: A Cluster Randomized Controlled Trial

Aline Uwimana et al. Clin Infect Dis. .

Abstract

Background: Malaria during pregnancy can cause serious consequences including maternal anemia and low birthweight (LBW). Routine antenatal care (ANC) in Rwanda includes malaria symptom screening at each ANC visit. This cluster randomized controlled trial investigated whether adding intermittent screening with a malaria rapid diagnostic test at each routine ANC visit and treatment of positives during pregnancy (ISTp) is more effective than routine ANC for reducing malaria prevalence at delivery.

Methods: Between September 2016 and June 2018, pregnant women initiating ANC at 14 health centers in Rwanda were enrolled into ISTp or control arms. All women received an insecticide-treated bed net at enrollment. Hemoglobin concentration, placental and peripheral parasitemia, newborn outcome, birthweight, and prematurity were assessed at delivery.

Results: Nine hundred seventy-five women were enrolled in ISTp and 811 in the control group. Routine ANC plus ISTp did not significantly reduce polymerase chain reaction-confirmed placental malaria compared to control (adjusted relative risk [aRR], 0.94 [95% confidence interval {CI}, .59-1.50]; P = .799). ISTp had no impact on anemia (aRR, 1.08 [95% CI, .57-2.04]; P = .821). The mean birthweight of singleton newborns was not significantly different between arms (3054 g vs 3096 g, P = .395); however, women in the ISTp arm had a higher proportion of LBW (aRR, 1.59 [95% CI, 1.02-2.49]; P = .042).

Conclusions: This is the only study to compare ISTp to symptomatic screening at ANC in a setting where intermittent preventive treatment is not routinely provided. ISTp did not reduce the prevalence of malaria or anemia at delivery and was associated with an increased risk of LBW.

Clinical trials registration: NCT03508349.

Keywords: Rwanda; intermittent screening; malaria; pregnancy.

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Conflict of interest statement

Potential conflicts of interest. D. S. reports serving as founder and board member with stock options from AliquantumRx; data and safety monitoring board (DSMB) for the National Institute of Allergy and Infectious Diseases (NIAID) safety monitoring committee/Independent Safety Monitor (SMC/ISM); royalties for malaria test from Binax Inc/D/B/A Inverness Medical; the following grants or contracts: Department of Defense (DoD) W911QY2090012 (payment to Johns Hopkins University [JHU]), NIAID 3R01AI152078-01S1 (payment to JHU), NIAID R01 AI150763-01A1, DoD TB210115 (payment to JHU), NIH/NIAID R01 AI111962-01 (payment to JHU), and NCATS R21 TR001737-01 (payment to JHU); royalties or licenses for plasmids for horseradish peroxidase aldolase for malaria diagnostic test; and patents (US patent [USP] 9 642 865, 9 May 2017, New angiogenesis inhibitors; issued USP 9 568 471, 14 February 2017, Malaria diagnosis in urine; issued USP 7 270 948, 18 September 2007, Detection of malaria parasites by laser desorption mass spectrometry; patent application #20210163522 (Salts and polymorphs of cethromycin for the treatment of disease). J. R. G. reports participation on DSMBs for the Pyrapreg study for the treatment of falciparum malaria in African pregnant women (PACTR202011812241529) and the ASPIRE trial (ClinicalTrials.gov identifier NCT04189744), and a leadership role as Co-Chair for the Roll Back Malaria, Malaria in pregnancy working group (unpaid). All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

Figures

None
This graphical abstract is also available at Tidbit: https://tidbitapp.io/tidbits/effectiveness-of-intermittent-screening-and-treatment-of-malaria-in-pregnancy-on-maternal-and-birth-outcomes-in-selected-districts-in-rwanda-a-cluster-randomized-controlled-trial
Figure 1.
Figure 1.
Study flow diagram. Abbreviation: ISTp, intermittent screening and treatment of malaria in pregnancy.
See this image and copyright information in PMC

References

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