Meta AnalysisID 2324
双氢青蒿素-哌喹作为磺胺多辛-乙胺嘧啶替代方案用于撒哈拉以南非洲孕妇间歇性预防治疗的安全性与疗效：一项个体参与者数据（IPD）Meta分析
CRD42020196127
Is intermittent preventive treatment with dihydroartemisinin-piperaquine (IPTp-DP) more efficacious than intermittent preventive treatment with sulfadoxine-pyrimethamine (IPTp-SP) for the prevention of malaria and advers
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Record Fields
Scalar fields from the final meta_analysis record.
- Meta Analysis Id
- 2324
- Evidence Id
- 10882
- Core Evidence Id
- 10882
- Source Meta Analysis Id
- 2273
- Herb2 Meta Analysis Id
- HBMA002273
- Crd Id
- CRD42020196127
- Title
- Safety and efficacy of dihydroartemisinin-piperaquine as an alternative to sulfadoxine-pyrimethamine for intermittent preventive treatment in pregnant women in sub-Saharan Africa: an individual participant data (IPD) meta-analysis
- Review Question
- Is intermittent preventive treatment with dihydroartemisinin-piperaquine (IPTp-DP) more efficacious than intermittent preventive treatment with sulfadoxine-pyrimethamine (IPTp-SP) for the prevention of malaria and adverse birth outcomes in sub-Saharan Africa?
- Study Type Included
- Randomised controlled trials conducted in sub-Saharan Africa evaluating IPTp-DP versus IPTp-SP among HIV-negative pregnant women. Studies/arms will only be included if there was a study-specific comparison group with the same IPTp dosing regimen. For example, a study arm will be excluded if women of the IPTp-DP arm were administered DP every 4 weeks and the only comparator IPTp-SP arm was one where women were administered SP every 8 weeks. Studies will be excluded if DP or SP was co-administered with another intervention (e.g. azithromycin or metronidazole).
- Condition Being Studied
- Malaria in pregnancy
- Participant
- Participants: HIV-negative pregnant women resident in malaria-endemic regions of sub-Saharan Africa Study inclusion criteria: • Trials randomising HIV-negative pregnant women to IPTp-SP or IPTp-DP • Followed women to delivery to assess malaria and delivery outcomes • Enrolled women with no history of receiving IPTp during her current pregnancy • Conducted in sub-Saharan Africa Study exclusion criteria: • HIV-positive pregnant women • No data collected on birth outcomes • Observational studies • Co-administration of SP or DP with another intervention (e.g. azithromycin or metronidazole) • Study arms of trials where the IPTp-DP arm followed a different dosing schedule than the IPTp-SP comparator arm
- Animal
- Human Disease Modelled
- Intervention
- Intermittent preventive treatment with dihydroartemisinin-piperaquine (IPTp-DP)
- Comparator Control
- Intermittent preventive treatment with sulfadoxine-pyrimethamine (IPTp-SP)
- Main Outcome
- 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 Relative risk and risk differences will be used to compare IPTp groups.
- Outcome Measure
- Additional Outcome
- • Difference in individual components of the primary outcome • Difference in 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) • 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 molecular methods); and maternal parasitaemia (the presence of asexual parasites in the peripheral blood of mother at delivery detected by microscopy or RDT) • Difference in maternal outcomes, measured by mean (SD) maternal haemoglobin and maternal anaemia. 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). • Difference in safety outcomes: frequency and severity of adverse events, congenital malformations, and maternal mortality • Difference in the incidence of infant malaria outcomes • Indirect and direct effects of IPTp on birth outcomes mediated through malaria and other potential ‘non-malarial’ mechanisms 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 count outcomes.
- Study Method
- Epidemiologic, Individual patient data (IPD) meta-analysis, Intervention, Meta-analysis, Systematic review
- Keyword
- Africa South of the Sahara; Artemisinins; Drug Combinations; Female; Humans; Pregnancy; Pyrimethamine; Quinolines; Sulfadoxine; dihydroartemisinin; fanasil, pyrimethamine drug combination; piperaquine
- Contact
- Julie Gutman [email protected]
- Organisational Affiliation
- Liverpool School of Tropical Medicine, Pembroke Place, Liverpool L3 5QA, UK and The Worldwide Antimalarial Resistance Network (WWARN) https://www.lstmed.ac.uk/; https://www.wwarn.org/
- Funding Source
- WWARN, which is funded by the Bill & Melinda Gates Foundation.
- Other Selection Criteria
- Final Publication
- Same Topic Review
- This meta-analysis is an update of a previous aggregated data meta-analysis [6] which included only two IPTp trials [7, 8]. This current study will include additional trials, which will provide new evidence across a wider range of epidemiological settings and more statistical power.
- Published Protocol
- Review Type
- Language
- English
- Country
- England, United States of America
- Review Stage
- Review Ongoing
- First Submission Date
- 2020-06-29
- Registration Date
- 2020-08-06
- Anticipated Start Date
- 2020-06-01
- Anticipated Completion Date
- 2020-12-31
- Title Cn
- 双氢青蒿素-哌喹作为磺胺多辛-乙胺嘧啶替代方案用于撒哈拉以南非洲孕妇间歇性预防治疗的安全性与疗效：一项个体参与者数据（IPD）Meta分析
- Title En
- Safety and efficacy of dihydroartemisinin-piperaquine as an alternative to sulfadoxine-pyrimethamine for intermittent preventive treatment in pregnant women in sub-Saharan Africa: an individual participant data (IPD) meta-analysis
- Bilingual Status
- complete