Meta AnalysisID 7591

双氢青蒿素-哌喹与磺胺多辛-乙胺嘧啶在妊娠期疟疾间歇性预防治疗中的比较：随机对照临床试验的系统评价与Meta分析

CRD42023437173

What is the therapeutic efficacy, safety and effect on the adverse birth outcome of Sulphadoxine-pyrimethamine versus Dihydroartemisinin-piperaquine in the intermittent prevention of malaria in pregnancy?

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Meta Analysis Id: 7591
Evidence Id: 16149
Core Evidence Id: 16149
Source Meta Analysis Id: 7583
Herb2 Meta Analysis Id: HBMA007583
Crd Id: CRD42023437173
Title: Is dihydroartemisinin-piperaquine comparable to sulfadoxine-pyrimethamine in the intermittent preventive treatment of malaria in pregnancy? a systematic review and meta-analysis of randomized controlled clinical trials.
Review Question: What is the therapeutic efficacy, safety and effect on the adverse birth outcome of Sulphadoxine-pyrimethamine versus Dihydroartemisinin-piperaquine in the intermittent prevention of malaria in pregnancy?
Study Type Included: Randomised controlled trials evaluating IPTp-DP versus IPTp-SP among HIV-negative pregnant women irrespective of the regimen used. Studies will be analysed based on the dosing regimen used for example monthly dosing or dosing two to three times in pregnancy. Studies, where DP or SP was co-administered with another intervention (e.g. azithromycin), will also be included and analysed in subgroup analysis.
Condition Being Studied: Malaria in pregnancy
Participant: Participants: Adult HIV-negative pregnant women in malaria-endemic regions of any part of the world Population: Randomized controlled trials conducted on adult pregnant women at gestational age > 12 weeks.
Animal
Human Disease Modelled
Intervention: Intervention – Studies that compared ITPp DP with ITPp SP among adult pregnant women.
Comparator Control: Comparison - Adult pregnant women given IPTp SP (standard of care) will be compared to pregnant women given IPTp DHP (comparator).
Main Outcome: Outcome – Efficacy in reducing placental malaria, the fetal and maternal outcome at birth. Trials will be considered eligible if they (1) enrolled HIV-seronegative pregnant women at >12 weeks of gestation; (2) compared DP with SP; (3) provided information on maternal or neonatal outcomes and adverse effects; (4)were a randomized clinical trial in design;. Studies will be excluded if they did not fit the eligibility criteria. Abstracts, reviews, case reports and retrospective studies will be excluded (unless they provided additional information from published RCTs). A composite measure of adverse birth outcomes defined as either miscarriage (foetal loss <28 gestational weeks), stillbirth (foetal loss ≥28 gestational weeks), low birthweight (LBW; <2, 500 grams), preterm birth (PTB; delivery <37 gestational weeks), small-for-gestational-age (SGA), or neonatal loss (neonatal death within the first 28 days of life) Measures of effect The relative risk and risk differences will be used to compare the two study groups (IPTpSP versus ITPp DHP).
Outcome Measure
Additional Outcome: Differences in individual components of the primary outcome Difference mean birthweight, mean gestational age at delivery, mean birthweight for gestational age Z-score Difference in birthweight percentiles (e.g. at 5th, 10th, 25th, 50th [median], 75th) The difference in the incidence of malaria outcomes during pregnancy and delivery, measured by: incidence of symptomatic malaria; placental parasitaemia (the presence of asexual parasites in the placenta at delivery by histology, microscopy, rapid diagnostic test (RDT), or PCR); and maternal parasitaemia (the presence of asexual parasites in the peripheral blood of mother at delivery detected by microscopy or RDT or PCR) The difference in maternal outcomes, measured by mean (SD) maternal haemoglobin and maternal anaemia at the time of delivery. The definition of any anaemia will depend on the kind of information that will be made available by the authors of the individual studies. If individual participant data is available, any anaemia will be defined as <11 g/dL. If only aggregated data is available, any anaemia will be included as defined by authors (e.g. <11 or 10 g/dL). Moderate-to-severe anaemia will be defined as <9 g/dL if individual participant data is available, otherwise as defined by authors (e.g. Hb <9 or 8 or 7 g/dL). The Difference in safety outcomes: frequency and severity of adverse events, congenital malformations, and maternal mortality The difference in the incidence of infant malaria outcomes will also be evaluated Measures of effect Relative risk ratio and risk differences will be used to compare binary outcomes; mean differences will be used to compare continuous outcomes; and incidence rate ratio and differences will be used to compare countinous outcomes
Study Method: Meta-analysis, Systematic review
Keyword: Female; Humans; Malaria; Pregnancy; Sulfadoxine; artenimol; fanasil, pyrimethamine drug combination; piperaquine
Contact: Mansur Ramalan [email protected]
Organisational Affiliation: AKTH
Funding Source: Nil Grant number(s) State the funder, grant or award number and the date of award Not applicable
Other Selection Criteria
Final Publication
Same Topic Review: Not applicable
Published Protocol
Review Type
Language: English
Country: Nigeria
Review Stage: Review Ongoing
First Submission Date: 2023-06-17
Registration Date: 2023-06-28
Anticipated Start Date: 2023-07-01
Anticipated Completion Date: 2023-09-30
Title Cn: 双氢青蒿素-哌喹与磺胺多辛-乙胺嘧啶在妊娠期疟疾间歇性预防治疗中的比较：随机对照临床试验的系统评价与Meta分析
Title En: Is dihydroartemisinin-piperaquine comparable to sulfadoxine-pyrimethamine in the intermittent preventive treatment of malaria in pregnancy? a systematic review and meta-analysis of randomized controlled clinical trials.
Bilingual Status: complete