A comparison of the efficacy of sulphadoxine-pyrimethamine with azithromycin versus sulphadoxine-pyrimethamine alone for malaria chemoprophylaxis in pregnancy: a triple-blind randomized controlled trial

R O Ogwu; PN Ebeigbe; S O Ilikannu

doi:10.4314/rmj.v82i3.5

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A comparison of the efficacy of sulphadoxine-pyrimethamine with azithromycin versus sulphadoxine-pyrimethamine alone for malaria chemoprophylaxis in pregnancy: a triple-blind randomized controlled trial

R O Ogwu, PN Ebeigbe, S O Ilikannu

Unknown Journal (2025) • Volume 82, Issue 3, Pages 44-52

Empirical-ClinicalRCTPDF AvailableGrade EligiblePre-registered (registry)⚠️ Moderate Risk Flags

Overall Assessment

Limited Methodological Quality

Assessment created by PaperScores Medical AI v0 on Dec 14, 2025

D+

50/100

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Quality Dimensions

Bias & Integrity

COI handling, outcome switching, selective reporting

C60

Methods Rigour

Protocol clarity, sampling, controls

C62

External Validity

Generalisability, setting, population

D+50

Transparency & Reproducibility

Data/code/materials availability, preregistration

D-38

Significance & Novelty

Contribution vs prior art; context if known

D-35

Statistical Validity

Models, assumptions, multiplicity, CI priority

D45

Integrity & Transparency

Integrity checks

P-hacking risk?

?

None suspected

Signs of selective hypothesis testing or analysis choices that could inflate false positive rates.

Outcome switching?

?

None suspected

Evidence that primary outcomes were changed during or after the study, potentially distorting results.

Conflict of interest?

?

None suspected

Authors have financial or other relationships that could bias research findings.

Data integrity issues?

?

Review recommended

Concerns about the accuracy, completeness, or authenticity of the reported data.

Open science signals

Research data

?

Not shared

Raw data used in the analyses is publicly available or accessible upon request.

Analysis code

?

Not shared

Code or scripts used to analyze the data are shared for reproducibility.

Study materials

?

Not shared

Protocols, questionnaires, and other materials are publicly available.

Premise

Primary Research Question

Is SPAZ more/at least as efficacious as SP for malaria chemoprophylaxis in pregnancy?

Hypothesis

SPAZ is as efficacious and safe as SP for IPTp.

Hypothesis is Falsifiable

✓Yes

Parasitaemia at delivery and placental/cord outcomes pre-specified.

PICO Framework

Population✓Yes

Booked pregnant women ≥16 weeks; clear exclusions.

Intervention✓Yes

SP plus azithromycin vs SP plus placebo; dosing frequency implied via IPTp doses.

Comparison✓Yes

Placebo-controlled SP comparator.

Outcome✓Yes

Maternal/cord/placental parasitaemia, anaemia, birthweight.

Literature Positioning

Literature Review Balanced

Well covered

Cites resistance data and prior SPAZ/IPTp trials across Africa/PNG.

Evidence: pp. 45–46, refs 8–14

Research Gap Clearly Stated

Well covered

SP resistance threatens IPTp efficacy; need alternatives.

Evidence: p. 45

Stated Contribution Clear

Well covered

Triple-blind RCT comparing SPAZ vs SP in Nigeria.

Evidence: Title; Abstract p. 44

Study Provenance

Peer reviewed venueFunding disclosedConflict disclosure provided4 affiliations listed

Authors & Affiliations

Dept. of Obstetrics & Gynaecology, FMC Asaba; Delta State Univ. Teaching Hospital, Nigeria.

Funding Statement

No funding was sought for this study.

Conflicts of Interest

All authors: no potential conflicts of interest disclosed.

Peer Review

✓Double-blind peer review; three reviewers.

Evidence: p. 44

Methodological Assessment

Randomized Controlled TrialCONSORTRCT

14 applicable checklist items.

Yes 9 · No 2 · Unclear 3

Study Design & Protocol

✓

Power Analysis Reported

Sample size calculation with parameters reported.

Evidence: p. 46

✓

Randomisation Adequate

Computer-generated numbers; sealed envelopes; independent pharmacist.

Evidence: p. 47

✓

Allocation Concealment

Sealed envelopes and pharmacist-held allocation suggest concealment.

Evidence: p. 47

✓

Blinding

Participants, outcome assessor, data analyst blinded (triple-blind).

Evidence: p. 47

✓

Blinding Adequate

Triple blinding maintained; placebo matched tablets.

Evidence: p. 47

?

Intervention Replicable

Drug doses/regimen sparse; only ‘four tablets’ and IPTp dose counts shown.

Evidence: pp. 47–48

✓

Outcomes Pre-specified

Primary and secondary outcomes stated a priori.

Evidence: p. 46

✓

Pre-registration Evidence

PACTR registration number provided.

Evidence: p. 45

Analysis & Reporting

✗

Analysis Set Appropriate (ITT/mITT)

3 post-randomisation exclusions; no ITT.

Evidence: Fig. 1 p. 46

✗

Missing Data Handled Appropriately

Exclusions without method; no imputation discussed.

Evidence: Fig. 1 p. 46

✓

Baseline Balance Acceptable

Baseline tables show no significant imbalances.

Evidence: Tables 1–2 pp. 47–48

?

Adherence Adequate

IPTp dose counts reported; adherence procedures not described.

Evidence: Fig. 2 p. 48

✓

Participant Flow Reported (CONSORT)

CONSORT flow diagram provided.

Evidence: Fig. 1 p. 46

?

Harms Reported Adequately

Only statement ‘No untoward adverse effects’; no AE collection detail.

Evidence: p. 50

Modules without applicable checklist items (8)

These designs were fully marked as not applicable but remain available for reference.

Abstract

INTRODUCTION: Sulphadoxine-pyrimethamine (SP) is the recommended drug for malaria chemoprophylaxis in pregnancy. However, there are growing reports of resistance to its use. This study compared the efficacy of Sulphadoxine-pyrimethamine with azithromycin (SPAZ) versus Sulphadoxine-pyrimethamine as chemoprophylactic agents against malaria in pregnancy. METHODS: A triple-blind randomized trial was conducted among women presenting for antenatal services between February and November 2023. One hundred women were randomized into two groups: those who received SP and a placebo (Group I) and those who received SPAZ (Group II). The collected data were coded and analyzed using Statistical Product and Service Solutions (SPSS) version 26, and p<0.05 was considered significant. RESULTS: There was no statistically significant difference between the two groups regarding the clearance of maternal parasites, maternal packed cell volume (PCV), cord blood parasites, fetal PCV, fetal birth weight, and placental parasitaemia despite having reduced incidences of anaemia and malaria parasitaemia in the SPAZ group. CONCLUSION: The results of this study suggest that SPAZ is as efficacious as SP for malaria chemoprophylaxis in pregnancy and can be used in place of SP in areas with established resistance to SP.

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Study Overview

Study Design

RCT

Primary classification used to evaluate this research.

Population

Pregnant women ≥16 weeks’ gestation booking at FMC Asaba, Nigeria (Feb–Nov 2023).

Brief summary of who or what was studied.

Sample Size

100

Number of participants included in the study analyses.

Study Arms

2 arms

Total number of intervention or comparison groups.

Pre-registration

Registered in a public registry

Indicates whether the protocol or trial was registered before data collection.

Randomisation

Simple randomisation

How participants were allocated to groups: None (no randomisation), Simple (random order), Blocked (groups balanced in blocks), Stratified (balanced within subgroups), Adaptive (allocation adjusted based on previous enrollments).

Blinding

Triple blind

Who was unaware of group assignments: None (everyone knew), Single blind (participants didn't know their group), Double blind (participants and researchers didn't know), Triple blind (also outcome assessors didn't know).

Analysis Set

Per protocol

Which participants were included in analysis: ITT (all randomized, regardless of adherence), mITT (modified ITT, excluding some for valid reasons), Per protocol (only those who completed as planned), As treated (grouped by actual treatment received), Other (alternative approach).

Follow-up

From enrolment to delivery.

Duration of observation or follow-up for outcomes.

Loss to Follow-up

0%

Percentage of participants who did not complete follow-up.

Primary Outcome

Primary outcome was pre-specified in the protocol or registry.

Reviewer Notes

Parallel-group triple-blind RCT comparing SPAZ vs SP for IPTp; analysed 97/100 (3 excluded post-randomisation).

Publication Details

DOI

10.4314/rmj.v82i3.5

Published

November 17, 2025

Citations

0 citations

External Resources

DOI Link OpenAlex

Disclaimer: This assessment is generated by AI and should not be the sole basis for clinical or research decisions. Always review the original paper and consult with domain experts.

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