Intermittent screening and treatment with artemether-lumefantrine versus intermittent preventive treatment with sulfadoxine-pyrimethamine for malaria in pregnancy: a facility-based, open-label, non-inferiority trial in Nigeria.

BACKGROUND: The spread of SP resistance may compromise the effectiveness of intermittent preventive treatment of malaria in pregnancy (MiP) with sulfadoxine-pyrimethamine (IPTp-SP) across Africa. However, there is no recommended alternative medicine for IPTp or alternative strategy for prevention of MiP. This poses problems for the prevention of MiP. This study investigated, whether screening with a rapid diagnostic test for malaria at routine antenatal clinic attendances and treatment of only those who are positive (intermittent screening and treatment) with artemether-lumefantrine is as effective and safe as IPTp-SP in pregnant women. METHODS: During antenatal clinic sessions at the General Hospital Calabar, Nigeria, held between October 2013 and November 2014, 459 pregnant women were randomized into either the current standard IPTp-SP or intermittent screening and treatment with artemether-lumefantrine (ISTp-AL). All women received a long-lasting insecticide-treated net at enrolment. Study women had a maximum of four scheduled visits following enrolment. Haemoglobin concentration and peripheral parasitaemia were assessed in the third trimester (36-40 weeks of gestation). Birth weight was documented at delivery or within a week for babies delivered at home. RESULTS: In the third trimester, the overall prevalence of severe anaemia (Hb < 8 g/dl) and moderate (8-10.9 g/dl) anaemia was 0.8 and 27.7%, respectively, and was similar in both treatment groups (p = 0.204). The risk of third-trimester severe anaemia did not differ significantly between both treatment arms (risk difference - 1.75% [95% CI - 4.16 to 0.66]) although the sample was underpowered for this outcome due to several participants being unavailable to give a blood sample. The risk of third-trimester maternal parasitaemia was significantly lower in the ISTp-AL arm (RD - 3.96% [95% CI - 7.76 to - 0.16]). The risk of low birthweight was significantly lower in the ISTp-AL arm after controlling for maternal age, gravidity and baseline parasitaemia (risk difference - 1.53% [95% CI - 1.54 to - 1.15]). Women in the ISTp-AL arm complained of fever more frequently compared to women in the IPTp-SP arm (p = 0.022). CONCLUSIONS: The trial results suggest that in an area of high malaria transmission with moderate sulfadoxine-pyrimethamine resistance, ISTp with artemether-lumefantrine may be an effective strategy for controlling malaria in pregnancy. Trial registration PACTR, PACTR201308000543272. Registered 29 April 2013, http://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?dar=true&tNo=PACTR201308000543272.

Deinfibulation for preventing or treating complications in women living with type III female genital mutilation: A systematic review and meta-analysis.

BACKGROUND: Deinfibulation is a surgical procedure carried out to re-open the vaginal introitus of women living with type III female genital mutilation (FGM). OBJECTIVES: To assess the impact of deinfibulation on gynecologic or obstetric outcomes by comparing women who were deinfibulated with women with type III FGM or women without FGM. SEARCH STRATEGY: Major databases including CENTRAL, MEDLINE, and Scopus were searched until August 2015. SELECTION CRITERIA: We included nonrandomized studies that compared obstetric outcomes of women with deinfibulation, type III FGM (not deinfibulated during labor), and no FGM. DATA COLLECTION AND ANALYSIS: Quality of evidence was determined following the GRADE methodology. Summary measures were calculated using odds ratios at 95% confidence intervals. RESULTS: We found no randomized controlled trials. We included four case-control studies. The quality of evidence was very low. Compared with women with type III FGM at delivery, deinfibulated women had a significant reduction in the risk of having a cesarean delivery or postpartum hemorrhage. Compared with women without FGM, deinfibulated women had a similar risk of episiotomy, cesarean delivery, vaginal lacerations, postpartum hemorrhage, and blood loss at vaginal delivery. The length of second stage of labor, mean maternal hospital stay, and Apgar scores less than 7 were also comparable. CONCLUSIONS: Low-quality evidence suggests deinfibulation improves birth outcomes for women with type III FGM. PROSPERO REGISTRATION: CRD42015024466.