scholarly journals Evaluation of the safety and efficacy of dihydroartemisinin–piperaquine for intermittent preventive treatment of malaria in HIV-infected pregnant women: protocol of a multicentre, two-arm, randomised, placebo-controlled, superiority clinical trial (MAMAH project)

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e053197
Author(s):  
Raquel González ◽  
Tacilta Nhampossa ◽  
Ghyslain Mombo-Ngoma ◽  
Johannes Mischlinger ◽  
Meral Esen ◽  
...  

IntroductionMalaria infection during pregnancy is an important driver of maternal and neonatal health especially among HIV-infected women. Intermittent preventive treatment in pregnancy (IPTp) with sulphadoxine–pyrimethamine is recommended for malaria prevention in HIV-uninfected women, but it is contraindicated in those HIV-infected on cotrimoxazole prophylaxis (CTXp) due to potential adverse effects. Dihydroartemisinin–piperaquine (DHA–PPQ) has been shown to improve antimalarial protection, constituting a promising IPTp candidate. This trial’s objective is to determine if monthly 3-day IPTp courses of DHA–PPQ added to daily CTXp are safe and superior to CTXp alone in decreasing the proportion of peripheral malaria parasitaemia at the end of pregnancy.Methods and analysisThis is a multicentre, two-arm, placebo-controlled, individually randomised trial in HIV-infected pregnant women receiving CTXp and antiretroviral treatment. A total of 664 women will be enrolled at the first antenatal care clinic visit in sites from Gabon and Mozambique. Participants will receive an insecticide-treated net, and they will be administered monthly IPTp with DHA-PPQ or placebo (1:1 ratio) as directly observed therapy from the second trimester of pregnancy. Primary study outcome is the prevalence of maternal parasitaemia at delivery. Secondary outcomes include prevalence of malaria-related maternal and infant outcomes and proportion of adverse perinatal outcomes. Participants will be followed until 6 weeks after the end of pregnancy and their infants until 1 year of age to also evaluate the impact of DHA–PPQ on mother-to-child transmission of HIV. The analysis will be done in the intention to treat and according to protocol cohorts, adjusted by gravidity, country, seasonality and other variables associated with malaria.Ethics and disseminationThe protocol was reviewed and approved by the institutional and national ethics committees of Gabon and Mozambique and the Hospital Clinic of Barcelona. Project results will be presented to all stakeholders and published in open-access journals.Trial registration numberNCT03671109.

Author(s):  
Kehinde Seun-Addie ◽  
Ezebunwa E. Nwokocha

The Roll Back Malaria (RBM) initiative was conceived to bolster appreciable reduction in the impact of malaria on pregnant women through Intermittent Preventive Treatment (IPT) and the use of Insecticide-treated Net (ITN). This study examines the association between knowledge and acceptability of the RBM programme on maternal health in Ibadan classified among areas with records of high prevalence of malaria-implicated maternal mortality. A survey of 407 pregnant women attending antenatal clinics at various Primary Health Centres (PHCs) in six selected Local Government Areas (LGAs) in Ibadan was undertaken. This clinic based approach was adopted to ensure that selected respondents were among those exposed to the RBM programme as antenatal care clinic attendees. Results show that increase in the knowledge of RBM related activities led to a corresponding increase in acceptability of the initiative, which ultimately led to marked improvement in maternal health. Thus, there is need to ensure that more women become aware of the RBM project as the surest trajectory for positive disposition to the RBM intervention, with a predictable concomitant improvement in maternal health status of childbearing women in Ibadan, Nigeria.


2020 ◽  
Vol 4 ◽  
pp. 34-39
Author(s):  
Ubong Akpan ◽  
Udeme Asibong ◽  
Zibrin Okhormbe ◽  
Mabel Ekott ◽  
Saturday Etuk

Objective: Malaria is a major cause of indirect maternal death. In the last two decades several efforts have been made to combat the menace of this disease especially among pregnant women and children in developing countries. Directly observed therapy (DOT) was recommended to enhance the uptake of intermittent preventive treatment (IPT) of malaria with sulfadoxine – pyrimethamine among pregnant women. Due to challenges involved in the practice of DOT especially with regards to shortage of man power and clean water in rural areas, there is need to evaluate impact of DOT on the effectiveness of treatment. Material and Methods: A cohort study was carried out among 320 healthy pregnant women receiving ante natal care with equal assignment of subjects. The study group (160) received two doses of IPT by DOT while 160 matched controls were given prescription for self- drug administration at home. Malaria tests were done using microscopy method and the hemoglobin values determined using centrifuge one month after the second dose of IPT. Umbilical cord blood samples were obtained for a repeat microscopy at delivery. Results: The results showed that there were no statistical significant differences in the venous blood parasitemia, placental parasitemia and anaemia between the DOT group and the control group (P = 0.215; P = 0.100; P = 0.966) respectively. Lower social class was the main predictor of anaemia in pregnancy (P = 0.032). Conclusion: The delivery of IPT through DOT may not influence uptake in some settings. Effort may need to be channeled into ante natal education and women empowerment.


2021 ◽  
Author(s):  
Ngaba Ngardig Neguemadji ◽  
Obélix Askemdet ◽  
Namrata Hange ◽  
Maria Kezia Lourdes Ligsay Pormento ◽  
Zeryab Ghous Dogar ◽  
...  

Abstract Background: The Chadian government established a program of free intermittent preventive treatment withsulfadoxine-pyrimethamine (IPTp-SP) for pregnant women. This program estimated the impact of IPTp-SP onthe malarial prevalence among women and newborn children, a study was planned for pregnant women whoconsulted in the Bon samaritain hospital in NDja mena, Chad.Methods: This 14 month study was conducted on 149 pregnant women. They were followed until delivery foroutcomes such as malaria attacks, anemia and placental malaria, low birth weight and prematurity in newborns.Data was collected with the help of a pretested questionnaire. Data was analysed with SPSS and R studio, Oddsrisk was calculated.Results: The mean age of the study participants was 25.8 ś 6.2 years with 72.5% under the age of 20 years,and half were housewives with a secondary school education. More than half of the pregnant women (84,56.3%) never used insecticide-treated mosquito nets. Among the 149 study participants, (64, 42,95%) received3 doses of IPTp-SP, while 31( 20.8%) did not receive any dose of IPTp-SP. Only 30% (45) of the total 149participants reported to be malaria positive; while 28.9% (43) were diagnosed with placental malaria. Of the43 placenta malaria cases, 21(48.83%) had not received SP. Most of the lower birth weight babies with weight< 2500g (40,81.64%) were reported in pregnant mothers who have reported administration of one or no doseof SP. Out of 31 pregnant women, 21 (67.7%) without IPTp-SP had reported at least one attack of malariaduring their pregnancy compared to 22 women out of 118(18.7%) of those who had at least one dose ofSulfamethoxazole pyrimethamine (p = 0.001 ). Out of 31 pregnant women who have not received IPTp-SP,26 women (83.9%) reported anaemiaw ith Hb <10.5g/dl while 17 (65.4%) with severeanemia Hb <8g/dl .Conclusion: The maternal rate of attack of malaria, placenta infestation, maternal anemia,and low birth weightbabies decrease considerably with administration of three or more doses of s ulfadoxine-pyrimethamine.


BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e027946 ◽  
Author(s):  
Felix Boakye Oppong ◽  
Stephaney Gyaase ◽  
Charles Zandoh ◽  
Obed Ernest A Nettey ◽  
Seeba Amenga-Etego ◽  
...  

ObjectiveIn Ghana, intermittent preventive treatment during pregnancy with sulphadoxine-pyrimethamine (IPTp-SP) is recommended for the prevention of malaria-related adverse outcomes. This study demonstrates the coverage of IPTp-SP use among pregnant women over a period (2011–2015) and the impact of various sociodemographic groups on the uptake of IPTp-SP.DesignRetrospective analysis using data from all pregnant women in the Kintampo Health and Demographic Surveillance System area on the uptake of IPTp-SP.SettingKintampo North Municipality and Kintampo South District of Ghana.ParticipantsAll pregnant women in the Kintampo Health and Demographic Surveillance System area.Primary and secondary outcome measuresThe number of doses of IPTp-SP taken by pregnant women were examined. Logistic regression was used to assess the determinant of uptake of IPTp-SP while adjusting for within-subject correlation from women with multiple pregnancies.ResultsData from 2011 to 2015 with a total of 17 484 pregnant women were used. The coverage of the recommended three or more doses of IPTp-SP among all pregnant women was 40.6%, 44.0%, 45.9%, 20.9% and 32.4% in 2011, 2012, 2013, 2014 and 2015, respectively. In the adjusted analysis, age, household size, education, religion, number of antenatal care visits, ethnicity, marital status, wealth index and place of residence were significantly associated with the uptake of three or more doses of IPTp-SP. Having middle school education or higher, aged 20 years and above, visiting antenatal care five times or more (OR 2.83, 95% CI 2.64 to 3.03), being married (OR 1.10, 95% CI 1.02 to 1.19) and those in higher wealth quintiles were significantly more likely to take three or more doses of IPTp-SP.ConclusionThe uptake of the recommended three or more doses of IPTp-SP is low in the study area. We recommend a community-based approach to identify women during early pregnancy and to administer IPTp-SP.


2021 ◽  
pp. archdischild-2021-322043
Author(s):  
Karoliina Videman ◽  
Lotta Hallamaa ◽  
Otto Heimonen ◽  
Charles Mangani ◽  
Mari Luntamo ◽  
...  

ObjectiveTo assess whether intermittent preventive treatment of pregnant women (IPTp) with sulfadoxine-pyrimethamine (SP) and azithromycin (AZI) in a malaria-endemic area leads to sustained gains in linear growth and development in their offspring.DesignFollow-up study of a randomised trial.SettingMangochi District in rural southern Malawi.Participants1320 pregnant women and their offspring.InterventionsIPTp monthly with SP and twice with AZI (AZI-SP group), monthly with SP but no AZI (monthly SP), or twice with SP (control). No intervention was given to children.Main outcome measuresCognitive performance using Raven’s Coloured Progressive Matrices (CPM) at 13 years of age; mean height and height-for-age Z-score (HAZ), cumulative incidence and prevalence of stunting (HAZ <−2); weight, body mass index, mid-upper-arm circumference and head circumference.ResultsAt approximately 13 years of age, the mean CPM score was 14.3 (SD 3.8, range 6–29, maximum 36), with no differences between groups. Children in the AZI-SP group were on average 0.4 cm (95% CI −0.9 to 1.7, p=0.6) taller than those in the control group. For cumulative incidence of stunting, the HR in the AZI-SP group was 0.72 (95% CI 0.61 to 0.84, p<0.001) compared with the control and 0.76 (95% CI 0.65 to 0.90, p<0.001) compared with the monthly SP groups. There was no intergroup difference in stunting prevalence or anthropometric measurements.ConclusionsIn rural Malawi, maternal intensified infection control during pregnancy reduces offspring’s cumulative incidence of ever being stunted by 13 years of age. In this study, there was no evidence of a positive impact on cognitive performance.Trial registration numberNCT00131235.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Shigeki Koshida ◽  
Shinsuke Tokoro ◽  
Daisuke Katsura ◽  
Shunichiro Tsuji ◽  
Takashi Murakami ◽  
...  

AbstractMaternal perception of decreased fetal movement is associated with adverse perinatal outcomes. Although there have been several studies on interventions related to the fetal movements count, most focused on adverse perinatal outcomes, and little is known about the impact of the fetal movement count on maternal behavior after the perception of decreased fetal movement. We investigated the impact of the daily fetal movement count on maternal behavior after the perception of decreased fetal movement and on the stillbirth rate in this prospective population-based study. Pregnant women in Shiga prefecture of Japan were asked to count the time of 10 fetal movements from 34 weeks of gestation. We analyzed 101 stillbirths after the intervention compared to 121 stillbirths before the intervention. In multivariable analysis, maternal delayed visit to a health care provider after the perception of decreased fetal movement significantly reduced after the intervention (aOR 0.31, 95% CI 0.11–0.83). Our regional stillbirth rates in the pre-intervention and post-intervention periods were 3.06 and 2.70 per 1000 births, respectively. Informing pregnant women about the fetal movement count was associated with a reduction in delayed maternal reaction after the perception of decreased fetal movement, which might reduce stillbirths.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Fatima Mahmud Muhammad ◽  
Saharnaz Nedjat ◽  
Haniye Sadat Sajadi ◽  
Mahboubeh Parsaeian ◽  
Abraham Assan ◽  
...  

Abstract Background While the use of sulphadoxine pyrimethamine (SP) is effective in preventing malaria infection during pregnancy, there are challenges limiting its uptake in Nigeria. This study aimed at exploring the barriers to IPTp usage among pregnant women in Kano state - Nigeria. Methods This is a qualitative study. The purposive sampling strategy was used for identification and selection of 14 key informants for interviews. In addition, six focus group discussions (FGDs) were conducted with pregnant women (3 FGDs) and married men (3 FGDs). The conventional content analysis method was used to interpret meaning from the content of the data. MAXQDA 10 software was used for data management and analysis. Results Poor policy implementation, poor antenatal care attendance, inadequate access to intermittent preventive treatment at the community levels, lack of sustainable funding, and poor community engagement emerged as major barriers to IPTp use in Nigeria. Conclusion While the political will to allocate sufficient financial resources could help improve service delivery and IPTp usage among pregnant women, community participation is critical to sustain the gains.


Author(s):  
Helle Hansson ◽  
Daniel T R Minja ◽  
Sofie L Moeller ◽  
John P A Lusingu ◽  
Ib C Bygbjerg ◽  
...  

Abstract Mutations in the Plasmodium falciparum genes Pfdhfr and Pfdhps, particularly the sextuple mutant haplotype threatens the antimalarial effectiveness of sulfadoxine-pyrimethamine as intermittent preventive treatment during pregnancy (IPTp). To explore the impact of sextuple mutant haplotype infections on outcome measures after provision of IPTp-SP, we monitored birth outcomes in women followed from prior to conception or from the first trimester until delivery. Women infected with sextuple haplotypes in early 2 nd trimester specifically, delivered newborns with a lower birth weight (-267g, 95% CI -454; -59, p=0·01) compared to women who did not have malaria during pregnancy and women infected with less SP resistant haplotypes (-461g, 95% CI -877; -44, p=0·03). Thus, sextuple haplotype infections seems to impact the effectiveness of SP for IPTp and directly impact birth outcome by lowering birth weight. Close monitoring and targeted malaria control during early pregnancy is therefore crucial to improve birth outcomes.


Author(s):  
T. Kasso ◽  
I. L. Oboro ◽  
O. Maduka ◽  
A. T. O. Awopeju ◽  
N. I. Paul ◽  
...  

Background: Malaria is a serious public health problem in developing countries with Africa bearing most of its burden. Pregnant women are more susceptible to malaria and it is one of the leading causes of maternal and perinatal mortality/morbidity. Use of effective malaria preventive measures during pregnancy reduces its burden and complications. Aim: This was to determine malaria preventive practices used by pregnant women in Akwa Ibom state, Nigeria. Materials and Methods: It was a cross sectional study of pregnant women attending public and private health facilities in Akwa Ibom state. An informed written consent was obtained from the participants. Stratified sampling method was used in selecting the health facilities and the study participants. Information was obtained with pretested questionnaires by trained personnel with the aid of Open Data Kit (ODK) on android phones. Data was managed with SPSS 22.0 and P-value of <0.05 was considered statistically significant. Results: There were 935 participants in the study. Their mean age was 28.52 ± 5.09 years with 879 (94.0%) being married. Most had secondary and tertiary degrees: 451(48.2%) and 440(47.1%). Majority of them were traders/business women and self-employed (58.2%) while 7% were unemployed. Malaria preventive practices were use of window net, bed net and insecticides accounting for 659(71%), 447(48.2%) and 207(22.3%) respectively. There were 612 (65.5%) participants that received malaria drugs for prevention with 452(73.9%) receiving Intermittent Preventive Treatment in Pregnancy (IPTp) with Sulfadoxine-Pyrimethamine (SP). Only 296 (31.7%) of them slept under bed nets the night before the interview. Conclusion: Common preventive practices employed by pregnant women were IPTp with SP, window nets, ITNs and modified IRS. Majority of the women utilized widow nets, though not as effective as ITNs. Efforts should be intensified concerning awareness creation about the benefits of ITN use during pregnancy.


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