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1.
BMC Pregnancy Childbirth ; 20(1): 14, 2020 Jan 06.
Artigo em Inglês | MEDLINE | ID: mdl-31906889

RESUMO

BACKGROUND: Major obstetric haemorrhage is a leading cause of maternal mortality and accounts for one-third of maternal deaths in of Africa. This study aimed to assess the population-based incidence, causes, management and outcomes of major obstetric haemorrhage and risk factors associated with poor maternal outcome. METHODS: Women with major obstetric haemorrhage who met the WHO maternal near-miss criteria or died in the Metro East region, Cape Town, South Africa, were evaluated from November 2014-November 2015. Major obstetric haemorrhage was defined as haemorrhage in pregnancies of at least 20 weeks' gestation or occurring up to 42 days after birth, and leading to hysterectomy, hypovolaemic shock or blood transfusion of ≥5 units of Packed Red Blood Cells. A logistic regression model was used to analyse associations with poor outcome, defined as major obstetric haemorrhage leading to massive transfusion of ≥8 units of packed red blood cells, hysterectomy or death. RESULTS: The incidence of major obstetric haemorrhage was 3/1000 births, and the incidence of massive transfusion was 4/10.000 births in the Metro East region (32.862 births occurred during the studied time period). Leading causes of haemorrhage were placental abruption 45/119 (37.8%), complications of caesarean section 29/119 (24.4%) and uterine atony 13/119 (10.9%). Therapeutic oxytocin was administered in 98/119 (82.4%) women and hysterectomy performed in 33/119 (27.7%). The median numbers of packed red blood cells and units of Fresh Frozen Plasma transfused were 6 (interquartile range 4-7) and 3 (interquartile range 2-4), ratio 1.7:1. Caesarean section was independently associated with poor maternal outcome: adjusted OR 4.01 [95% CI 1.58, 10.14]. CONCLUSIONS: Assessment of major obstetric haemorrhage using the Maternal Near Miss approach revealed that placental abruption and complications of caesarean section were the major causes of major obstetric haemorrhage. Caesarean section was associated with poor outcome.

2.
Am J Obstet Gynecol ; 2020 Jan 06.
Artigo em Inglês | MEDLINE | ID: mdl-31917139

RESUMO

OBJECTIVE: To assess the efficacy, effectiveness, and safety of uterine balloon tamponade for treating postpartum hemorrhage. STUDY DESIGN: We searched electronic databases (from their inception to August 2019) and bibliographies. We included randomized controlled trials, nonrandomized studies, and case series that reported on the efficacy, effectiveness, and/or safety of uterine balloon tamponade in women with postpartum hemorrhage. The primary outcome was the success rate of uterine balloon tamponade for treating postpartum hemorrhage (number of uterine balloon tamponade success cases/total number of women treated with uterine balloon tamponade). For meta-analyses, we calculated pooled success rate for all studies, and relative risk with 95% confidence intervals for studies that included a comparative arm. RESULTS: Ninety-one studies, including 4729 women, met inclusion criteria (6 randomized trials, 1 cluster randomized trial, 15 nonrandomized studies, and 69 case series). The overall pooled uterine balloon tamponade success rate was 85.9% (95% confidence interval, 83.9-87.9%). The highest success rates corresponded to uterine atony (87.1%) and placenta previa (86.8%), and the lowest to placenta accreta spectrum (66.7%) and retained products of conception (76.8%). The uterine balloon tamponade success rate was lower in cesarean deliveries (81.7%) than in vaginal deliveries (87.0%). A meta-analysis of 2 randomized trials that compared uterine balloon tamponade vs no uterine balloon tamponade in postpartum hemorrhage due to uterine atony after vaginal delivery showed no significant differences between the study groups in the risk of surgical interventions or maternal death (relative risk, 0.59; 95% confidence interval, 0.02-16.69). A meta-analysis of 2 nonrandomized before-and-after studies showed that introduction of uterine balloon tamponade in protocols for managing severe postpartum hemorrhage significantly decreased the use of arterial embolization (relative risk, 0.29; 95% confidence interval, 0.14-0.63). A nonrandomized cluster study reported that use of invasive procedures was significantly lower in the perinatal network that routinely used uterine balloon tamponade than that which did not use uterine balloon tamponade (3.0/1000 vs 5.1/1000; P < .01). A cluster randomized trial reported that the frequency of postpartum hemorrhage-related invasive procedures and/or maternal death was significantly higher after uterine balloon tamponade introduction than before uterine balloon tamponade introduction (11.6/10,000 vs 6.7/10,000; P = .04). Overall, the frequency of complications attributed to uterine balloon tamponade use was low (≤6.5%). CONCLUSION: Uterine balloon tamponade has a high success rate for treating severe postpartum hemorrhage and appears to be safe. The evidence on uterine balloon tamponade efficacy and effectiveness from randomized and nonrandomized studies is conflicting, with experimental studies suggesting no beneficial effect, in contrast with observational studies. Further research is needed to determine the most effective programmatic and healthcare delivery strategies on uterine balloon tamponade introduction and use.

3.
PLoS One ; 15(1): e0228003, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31999753

RESUMO

BACKGROUND: Given well documented challenges faced by pregnant women living with HIV taking lifetime ART, it is critical to understand the impact of short-term ART exposure followed by treatment interruption on maternal health outcomes. METHODS: HIV+ breastfeeding (BF) and Formula Feeding (FF) women with CD4 counts > 350 cells/mm3, enrolled in the 1077BF/1077FF PROMISE trial were followed to assess the effect of ART during pregnancy and breastfeeding respectively. The first analysis compared ART use limited to the antepartum period (AP-only) relative to women randomized to Zidovudine. The second analysis included women with no pregnancy combination ART exposure; and compared women randomized to either ART or no ART during postpartum (PP-only). Both analyses included follow-up time beyond breastfeeding period. The primary outcome was progression to AIDS and/or death. Secondary outcomes included adverse events and HIV-related events. RESULTS: 3490 and 1137 HIV+ women were enrolled from 14 sites in Africa and India from April 2011 through September 2014 in cohort AP-only and PP-only, respectively. Most were Black African (96%); median age was 27 years; 97% were WHO Clinical Stage I; and most had a screening CD4 count ≥500 cells/mm3 (78%). The rate of progression to AIDS and/or death was similar and low across all comparison arms (AP comparison, HR = 1.14, 95%CI (0.44, 2.96), p-value = 0.79). In the PP-only cohort, the rate of WHO stage 2-3 events was lower for women randomized to ART(HR = 0.65, 95% CI 0.42, 1.01, p-value = 0.05). CONCLUSION: The incidence of AIDS and/or death was low in pregnant/postpartum HIV+ women with highCD4 cell counts for all comparison arms. This provides some reassurance that there were limited consequences for short term ART interruption in this group of asymptomatic HIV+ women during up to 4 years of follow up; and underscores that even short term ART exposure postpartum may reduce the risk of WHO grade 2-3 disease progression.

4.
J Infect Dis ; 2019 Nov 04.
Artigo em Inglês | MEDLINE | ID: mdl-31681963

RESUMO

BACKGROUND: While mother-to-child HIV transmission has dramatically decreased with maternal antiretroviral therapy, breast milk transmission accounts for most of the 180,000 new infant HIV infections annually. Broadly neutralizing antibodies (bNAb) may further reduce transmission. METHODS: A Phase I safety and pharmacokinetic study was conducted: a single subcutaneous (SC) dose of 20 or 40 mg/kg (Dose Groups 1 and 2, respectively) of the bNAb VRC01 was administered to HIV-exposed infants soon after birth. Breastfeeding infants (Dose Group 3) received 40 mg/kg SC VRC01 after birth and then 20 mg/kg/dose SC monthly. All infants received appropriate antiretroviral prophylaxis. RESULTS: Forty infants were enrolled (21 US, 19 Africa). SC VRC01 was safe and well tolerated with only mild-to-moderate local reactions, primarily erythema, which rapidly resolved. For multiple-dose infants local reactions decreased with subsequent injections. VRC01 was rapidly absorbed following administration, with peak concentrations 1-6 days post-dose. The 40 mg/kg dose resulted in 13/14 infants achieving the serum 50 mcg/mL target at day 28. Dose Group 3 infants maintained concentrations greater than 50 mcg/mL throughout breastfeeding. CONCLUSIONS: SC VRC01 as single or multiple doses is safe and well-tolerated in very young infants and is suitable for further study to prevent HIV transmission in infants.

5.
N Engl J Med ; 381(14): 1333-1346, 2019 10 03.
Artigo em Inglês | MEDLINE | ID: mdl-31577875

RESUMO

BACKGROUND: The safety, efficacy, and appropriate timing of isoniazid therapy to prevent tuberculosis in pregnant women with human immunodeficiency virus (HIV) infection who are receiving antiretroviral therapy are unknown. METHODS: In this multicenter, double-blind, placebo-controlled, noninferiority trial, we randomly assigned pregnant women with HIV infection to receive isoniazid preventive therapy for 28 weeks, initiated either during pregnancy (immediate group) or at week 12 after delivery (deferred group). Mothers and infants were followed through week 48 after delivery. The primary outcome was a composite of treatment-related maternal adverse events of grade 3 or higher or permanent discontinuation of the trial regimen because of toxic effects. The noninferiority margin was an upper boundary of the 95% confidence interval for the between-group difference in the rate of the primary outcome of less than 5 events per 100 person-years. RESULTS: A total of 956 women were enrolled. A primary outcome event occurred in 72 of 477 women (15.1%) in the immediate group and in 73 of 479 (15.2%) in the deferred group (incidence rate, 15.03 and 14.93 events per 100 person-years, respectively; rate difference, 0.10; 95% confidence interval [CI], -4.77 to 4.98, which met the criterion for noninferiority). Two women in the immediate group and 4 women in the deferred group died (incidence rate, 0.40 and 0.78 per 100 person-years, respectively; rate difference, -0.39; 95% CI, -1.33 to 0.56); all deaths occurred during the postpartum period, and 4 were from liver failure (2 of the women who died from liver failure had received isoniazid [1 in each group]). Tuberculosis developed in 6 women (3 in each group); the incidence rate was 0.60 per 100 person-years in the immediate group and 0.59 per 100 person-years in the deferred group (rate difference, 0.01; 95% CI, -0.94 to 0.96). There was a higher incidence in the immediate group than in the deferred group of an event included in the composite adverse pregnancy outcome (stillbirth or spontaneous abortion, low birth weight in an infant, preterm delivery, or congenital anomalies in an infant) (23.6% vs. 17.0%; difference, 6.7 percentage points; 95% CI, 0.8 to 11.9). CONCLUSIONS: The risks associated with initiation of isoniazid preventive therapy during pregnancy appeared to be greater than those associated with initiation of therapy during the postpartum period. (Funded by the National Institutes of Health; IMPAACT P1078 TB APPRISE ClinicalTrials.gov number, NCT01494038.).


Assuntos
Infecções Oportunistas Relacionadas com a AIDS/prevenção & controle , Antituberculosos/uso terapêutico , Infecções por HIV/tratamento farmacológico , Isoniazida/uso terapêutico , Complicações Infecciosas na Gravidez/tratamento farmacológico , Resultado da Gravidez , Tuberculose/prevenção & controle , Adolescente , Adulto , Antituberculosos/efeitos adversos , Método Duplo-Cego , Feminino , Humanos , Lactente , Mortalidade Infantil , Recém-Nascido , Recém-Nascido de muito Baixo Peso , Isoniazida/efeitos adversos , Testes de Função Hepática , Período Pós-Parto , Gravidez , Nascimento Prematuro/epidemiologia , Estudos Prospectivos , Adulto Jovem
6.
J Acquir Immune Defic Syndr ; 81(5): 521-532, 2019 Aug 15.
Artigo em Inglês | MEDLINE | ID: mdl-31295174

RESUMO

BACKGROUND: In the multicountry PROMISE 1077BF/1077FF trial, the risk of low birth weight (LBW; <2500 g) and preterm delivery (PTD; <37 weeks) was significantly higher among women initiating a protease inhibitor-based antiretroviral treatment (ART) regimen than those receiving ZDV alone. Among those assigned to a protease inhibitor regimen, tenofovir/emtricitabine was associated with the more severe outcomes of very LBW (<1500 g) and very PTD (<34 weeks) compared with zidovudine/lamivudine. METHODS: We used multivariate logistic regression to further explore these treatment findings, taking into account demographic baseline clinical and postentry obstetrical factors. We evaluated individual adverse outcomes and composites that included stillbirth and early loss/spontaneous abortion. RESULTS: Among 3333 women delivering at least 1 live infant, median maternal age at enrollment was 26 years; 661 (20%) were primiparous, and 110 (3.3%) reported at least 1 previous PTD. Seventeen percent of newborns were LBW, 1% were very LBW, 17% had PTD, and 3% had very PTD. Treatment allocation remained strongly associated with multiple adverse outcomes after controlling for other risk factors with both ART regimens exhibiting increased risk relative to ZDV alone. Other risk factors remaining significant in at least one of the multivariate models included the following: country, gestational age at entry, maternal age, maternal body mass index, previous PTD, history of alcohol use, baseline HIV viral titer, multiple gestation, and several obstetric risk factors. CONCLUSIONS: ART effects on adverse pregnancy outcomes reported in the randomized PROMISE trial remained strongly significant even after controlling for demographic, baseline clinical, and obstetrical risk factors, which were also associated with these outcomes.

7.
Int J Gynaecol Obstet ; 146(1): 25-28, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31055829

RESUMO

OBJECTIVE: Adequate obstetric care requires the availability of essential diagnostic and management equipment; however, for centers with budget restrictions, the acquisition and maintenance of these devices can pose major challenges. The purpose of the present paper is to disseminate knowledge about the availability of affordable and low-maintenance obstetric devices, which might help to save lives in low- and medium-resource countries. METHOD: Over the course of 2015-2018, the International Federation of Gynecology and Obstetrics (FIGO) Safe Motherhood and Newborn Health Committee acquired information from different clinical and commercial sources regarding the availability of affordable and low-maintenance essential obstetric devices. RESULTS: The Committee identified several devices that met the criteria of low cost and ease of maintenance: a winding handheld Doppler device for intermittent auscultation; a portable continuous fetal heart rate monitor; a validated semi-automated blood pressure monitor; the Foley catheter balloon for labor induction in women with an unfavorable cervix; reusable metal and plastic vacuum cups and manual pumps; an intrauterine tamponade balloon; and the non-pneumatic anti-shock garment. CONCLUSION: Several affordable and low-maintenance obstetric devices are currently available that offer the potential to save lives in resource-constrained settings.


Assuntos
Obstetrícia/instrumentação , Oclusão com Balão/instrumentação , Determinação da Pressão Arterial/instrumentação , Cardiotocografia/instrumentação , Feminino , Humanos , Recém-Nascido , Trabalho de Parto Induzido/instrumentação , Obstetrícia/economia , Gravidez , Ultrassonografia Doppler/instrumentação , Cateterismo Urinário/instrumentação , Vácuo-Extração/instrumentação
8.
Int J Gynaecol Obstet ; 146(1): 103-109, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31055843

RESUMO

OBJECTIVE: To determine incidence, risk indicators, and outcomes of emergency peripartum hysterectomy (EPH) in Metro East, Cape Town, South Africa. METHODS: A population-based district-wide prospective descriptive study of EPH in public hospitals from November 2014 to November 2015. Women were enrolled by using the WHO maternal near miss tool and followed until discharge. EPH was defined as hemorrhage or infection leading to hysterectomy during pregnancy or within 42 days of delivery. RESULTS: Fifty-nine women experienced EPH with an overall incidence of 14.3 per 10 000 women: 32 procedures were for postpartum hemorrhage, 27 for puerperal sepsis. Two women died: one from sepsis; one from hemorrhage. Overall, 51 (86%) women delivered by cesarean, and 23/51 (45%) by repeat cesarean. As compared with hemorrhage, EPH for sepsis involved older women (mean age, 31.5 vs 24.4 years) and those with higher gravidity (median, 3 vs 1), and was associated with longer hospital admission (median, 11.5 vs 4 days), with occurrence later postpartum (median, 8 vs 0 days), and more frequently with complications. CONCLUSIONS: The incidence of EPH for sepsis was higher than previously reported. Repeat cesarean was strongly associated with EPH. Clinical characteristics of sepsis-related EPH compared unfavorably with those of hemorrhage-related EPH.


Assuntos
Histerectomia/estatística & dados numéricos , Hemorragia Pós-Parto/epidemiologia , Complicações Infecciosas na Gravidez/epidemiologia , Sepse/epidemiologia , Adulto , Feminino , Hospitais Públicos/estatística & dados numéricos , Humanos , Incidência , Mortalidade Materna , Período Periparto , Hemorragia Pós-Parto/cirurgia , Gravidez , Complicações Infecciosas na Gravidez/cirurgia , Estudos Prospectivos , Estudos Retrospectivos , Fatores de Risco , Sepse/cirurgia , África do Sul/epidemiologia , Adulto Jovem
9.
Int J Gynaecol Obstet ; 146(1): 29-35, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31017650

RESUMO

Patients at risk of organ dysfunction or with established organ dysfunction should be referred to central or tertiary-level hospitals. However, even in central hospitals, intensive care unit (ICU) beds are often unavailable, which may contribute to maternal deaths. One pragmatic solution is to establish obstetric critical care units (OCCUs) in the labor wards of central hospitals; however, specific guidance on how to do this is limited. In addition, globally applicable standards of care are lacking, with uncertainty regarding who should lead obstetric critical care. In this article the specific OCCU infrastructure, equipment and human resources required to establish such units in central hospitals in low- and middle-income countries are described in sufficient detail for easy replication. Admission and discharge guidelines and operational recommendations that include quality indicators are also provided.


Assuntos
Arquitetura Hospitalar/métodos , Unidades de Terapia Intensiva/organização & administração , Obstetrícia/organização & administração , Cuidados Críticos/organização & administração , Feminino , Humanos , Morte Materna/prevenção & controle , Recursos Humanos de Enfermagem no Hospital/organização & administração , Gravidez , Complicações na Gravidez/terapia
10.
Int J Gynaecol Obstet ; 146(1): 3-7, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30927443

RESUMO

International standards for clinical staffing of delivery care in maternity units are currently lacking, with resulting gaps in provision leading to adverse outcomes and very poor experiences of care for women and families. While evidence-informed modelling approaches have been proposed based on population characteristics and estimated rates of complications, their application and outcomes in low-resource settings have not been reported. Here, FIGO's Safe Motherhood and Newborn Health Committee proposes indicative standards for labor wards as a starting point for policy and program development. These standards consider the volume of deliveries, the case mix, and the need to match clinical care requirements with an appropriate mix of professional skills among midwifery and obstetric staff. The role of Shift Leader in busy labor wards is emphasized. Application of the standards can help to assure women and their families of a safe but also positive birthing experience. FIGO calls for investment by partners to test these clinically-informed recommendations for delivery unit staffing at hospital and district level in low- and middle-income country settings.


Assuntos
Parto Obstétrico/normas , Recursos Humanos/normas , Adulto , Feminino , Humanos , Recém-Nascido , Tocologia/normas , Segurança do Paciente , Assistência Perinatal/normas , Gravidez
11.
Int J Gynaecol Obstet ; 146(1): 8-16, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30582153

RESUMO

OBJECTIVE: To determine acceptable and achievable strategies of intrapartum fetal monitoring in busy low-resource settings. METHODS: Three rounds of online Delphi surveys were conducted between January 1 and October 31, 2017. International experts with experience in low-resource settings scored the importance of intrapartum fetal monitoring methods. RESULTS: 71 experts completed all three rounds (28 midwives, 43 obstetricians). Consensus was reached on (1) need for an admission test, (2) handheld Doppler for intrapartum fetal monitoring, (3) intermittent auscultation (IA) every 30 minutes for low-risk pregnancies during the first stage of labor and after every contraction for high-risk pregnancies in the second stage, (4) contraction monitoring hourly for low-risk pregnancies in the first stage, and (5) adjunctive tests. Consensus was not reached on frequency of IA or contraction monitoring for high-risk women in the first stage or low-risk women in the second stage of labor. CONCLUSION: There is a gap between international recommendations and what is physically possible in many labor wards in low-resource settings. Research on how to effectively implement the consensus on fetal assessment at admission and use of handheld Doppler during labor and delivery is crucial to support staff in achieving the best possible care in low-resource settings.


Assuntos
Monitorização Fetal/normas , Frequência Cardíaca Fetal , Adulto , Consenso , Técnica Delfos , Feminino , Humanos , Primeira Fase do Trabalho de Parto , Segunda Fase do Trabalho de Parto , Pobreza , Gravidez , Inquéritos e Questionários , Ultrassonografia Doppler
13.
Pediatr Infect Dis J ; 37(10): 1016-1021, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30216294

RESUMO

BACKGROUND: Congenital cytomegalovirus (CMV) infection (cCMV) is an important cause of hearing loss and cognitive impairment. Prior studies suggest that HIV-exposed children are at higher risk of acquiring cCMV. We assessed the presence, magnitude and risk factors associated with cCMV among infants born to HIV-infected women, who were not receiving antiretrovirals during pregnancy. METHODS: cCMV and urinary CMV load were determined in a cohort of infants born to HIV-infected women not receiving antiretrovirals during pregnancy. Neonatal urines obtained at birth were tested for CMV DNA by qualitative and reflex quantitative real-time polymerase chain reaction. RESULTS: Urine specimens were available for 992 (58.9%) of 1684 infants; 64 (6.5%) were CMV-positive. Mean CMV load (VL) was 470,276 copies/ml (range: < 200-2,000,000 copies/ml). Among 89 HIV-infected infants, 16 (18%) had cCMV versus 42 (4.9%) of 858 HIV-exposed, uninfected infants (P < 0.0001). cCMV was present in 23.2% of infants with in utero and 9.1% infants with intrapartum HIV infection (P < 0.0001). Rates of cCMV among HIV-infected infants were 4-fold greater (adjusted OR, 4.4; 95% CI: 2.3-8.2) and 6-fold greater among HIV in utero-infected infants (adjusted OR, 6; 95% CI: 3-12.1) compared with HIV-exposed, uninfected infants. cCMV was not associated with mode of delivery, gestational age, Apgar scores, 6-month infant mortality, maternal age, race/ethnicity, HIV viral load or CD4 count. Primary cCMV risk factors included infant HIV-infection, particularly in utero infection. CONCLUSION: High rates of cCMV with high urinary CMV VL were observed in HIV-exposed infants. In utero HIV infection appears to be a major risk factor for cCMV in infants whose mothers have not received combination antiretroviral therapy in pregnancy.


Assuntos
Infecções por Citomegalovirus/congênito , Infecções por HIV/complicações , Infecções por HIV/transmissão , Transmissão Vertical de Doença Infecciosa , Complicações Infecciosas na Gravidez/virologia , Antirretrovirais/uso terapêutico , Estudos de Coortes , Citomegalovirus , Infecções por Citomegalovirus/etiologia , DNA Viral/urina , Feminino , Humanos , Lactente , Recém-Nascido , Gravidez , Reação em Cadeia da Polimerase em Tempo Real , Fatores de Risco , Carga Viral
14.
Am J Obstet Gynecol ; 219(4): 388.e1-388.e17, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30055127

RESUMO

BACKGROUND: Preterm preeclampsia has a high rate of fetal death or disability. There is no treatment to slow the disease, except delivery. Preclinical studies have identified proton pump inhibitors as a possible treatment. OBJECTIVE: The purpose of this study was to examine whether esomeprazole could prolong pregnancy in women who have received a diagnosis of preterm preeclampsia. STUDY DESIGN: We performed a double-blind, randomized controlled trial at Tygerberg Hospital in South Africa. Women with preterm preeclampsia (gestational age 26 weeks+0 days to 31 weeks+6 days) were assigned randomly to 40-mg daily esomeprazole or placebo. The primary outcome was a prolongation of gestation of 5 days. Secondary outcomes were maternal and neonatal outcomes. We compared circulating markers of endothelial dysfunction that was associated with preeclampsia and performed pharmacokinetic studies. RESULTS: Between January 2016 and April 2017, we recruited 120 participants. One participant was excluded because of incorrect randomization, which left 59 participants in the esomeprazole and 60 participants in the placebo group. Median gestational age at enrolment was 29+4 weeks gestation. There were no between-group differences in median time from randomization to delivery: 11.4 days (interquartile range, 3.6-19.7 days) in the esomeprazole group and 8.3 days (interquartile range, 3.8-19.6 days) in the placebo group (3 days longer in the esomeprazole arm; 95% confidence interval, -2.9-8.8; P=.31). There were no placental abruptions in the esomeprazole group and 6 (10%) in the placebo group (P=.01, P=.14 adjusted). There were no differences in other maternal or neonatal outcomes or markers of endothelial dysfunction. Esomeprazole and its metabolites were detected in maternal blood among those treated with esomeprazole, but only trace amounts in the umbilical cord blood. CONCLUSION: Daily esomeprazole (40 mg) did not prolong gestation in pregnancies with preterm preeclampsia or decrease circulating soluble fms-like tyrosine kinase 1 concentrations. Higher levels in the maternal circulation may be needed for clinical effect.


Assuntos
Esomeprazol/uso terapêutico , Pré-Eclâmpsia , Nascimento Prematuro/prevenção & controle , Cuidado Pré-Natal , Inibidores da Bomba de Prótons/uso terapêutico , Adulto , Esomeprazol/administração & dosagem , Feminino , Humanos , Gravidez , Terceiro Trimestre da Gravidez , Inibidores da Bomba de Prótons/administração & dosagem , África do Sul , Resultado do Tratamento , Adulto Jovem
15.
Pediatr Infect Dis J ; 37(12): 1271-1278, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-29750766

RESUMO

BACKGROUND: HIV-exposed uninfected (HEU) infants are a growing population with potentially poor health outcomes. We evaluated morbidity and mortality in HEU formula-fed infants enrolled in the NICHD HPTN 040/PACTG 1043 trial. METHODS: Infectious morbidity, mortality and undernutrition were evaluated within a cohort of 1000 HEU infants enrolled between April 2004 and April 2010 in Brazil (n = 766) and South Africa (n = 234) as part of the NICHD/HPTN 040 trial of 3 different antiretroviral regimens to decrease intrapartum HIV vertical transmission. RESULTS: Twenty-three percent of infants had at least 1 infectious serious adverse effect. Infants born to mothers with <12 years of education [adjusted odds ratio (AOR), 2.6; 95% confidence interval [CI], 1.2-5.9), with maternal viral load of >1,000,000 copies/mL at delivery (AOR, 9.9; 95% CI, 1.6-63.1) were more likely to have infectious serious adverse effects. At 6 months, the infant mortality rate per 1000 live births overall was 22 ± 2.6, 9.1 ± 1.8 in Brazil and 64.1 ± 3 in South Africa. Undernutrition and stunting peaked at 1 month of age with 18% having a weight-for-age Z score ≤-2, and 22% with height for Z score ≤-2. The likelihood of infant mortality was greater among infants born in South Africa compared with Brazil (AOR, 6.2; 95% CI, 2.5-15.8), high maternal viral load (AOR, 1.7; 95% CI, 1.01-2.9) and birth weight-for-age Z score ≤-2 (AOR, 5.2; 95% CI, 1.8-14.8). CONCLUSIONS: There were high rates of undernutrition, stunting and infectious serious adverse effect in this study's formula-fed HEU population. Suppressing maternal HIV viral load during the peripartum period may be a modifiable risk factor to decrease infant mortality.


Assuntos
Fármacos Anti-HIV/uso terapêutico , Infecções por HIV/complicações , Mortalidade Infantil , Transmissão Vertical de Doença Infecciosa/estatística & dados numéricos , Brasil/epidemiologia , Causas de Morte , Feminino , Seguimentos , Infecções por HIV/tratamento farmacológico , Infecções por HIV/mortalidade , Humanos , Lactente , Fórmulas Infantis , Masculino , Desnutrição/epidemiologia , Desnutrição/etiologia , Estado Nutricional , Gravidez , Complicações Infecciosas na Gravidez/tratamento farmacológico , Complicações Infecciosas na Gravidez/mortalidade , Fatores de Risco , África do Sul/epidemiologia , Carga Viral
17.
PLoS One ; 13(1): e0189851, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29304083

RESUMO

BACKGROUND: Sexually transmitted infections (STIs) including Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Treponema pallidum (TP), and cytomegalovirus (CMV) may lead to adverse pregnancy and infant outcomes. The role of combined maternal STIs in HIV mother-to-child transmission (MTCT) was evaluated in mother-infant pairs from NICHD HPTN 040. METHODOLOGY: Urine samples from HIV-infected pregnant women during labor were tested by polymerase chain reaction (PCR) for CT, NG, and CMV. Infant HIV infection was determined by serial HIV DNA PCR testing. Maternal syphilis was tested by VDRL and confirmatory treponemal antibodies. RESULTS: A total of 899 mother-infant pairs were evaluated. Over 30% had at least one of the following infections (TP, CT, NG, and/or CMV) detected at the time of delivery. High rates of TP (8.7%), CT (17.8%), NG (4%), and CMV (6.3%) were observed. HIV MTCT was 9.1% (n = 82 infants). HIV MTCT was 12.5%, 10.3%, 11.1%, and 26.3% among infants born to women with CT, TP, NG or CMV respectively. Forty-two percent of HIV-infected infants were born to women with at least one of these 4 infections. Women with these infections were nearly twice as likely to have an HIV-infected infant (aOR 1.9, 95% CI 1.1-3.0), particularly those with 2 STIs (aOR 3.4, 95% CI 1.5-7.7). Individually, maternal CMV (aOR 4.4 1.5-13.0) and infant congenital CMV (OR 4.1, 95% CI 2.2-7.8) but not other STIs (TP, CT, or NG) were associated with an increased risk of HIV MTCT. CONCLUSION: HIV-infected pregnant women identified during labor are at high risk for STIs. Co-infection with STIs including CMV nearly doubles HIV MTCT risk. CMV infection appears to confer the largest risk of HIV MTCT. TRIAL REGISTRATION: NCT00099359.


Assuntos
Infecções por HIV/complicações , Infecções por HIV/transmissão , Transmissão Vertical de Doença Infecciosa , Complicações Infecciosas na Gravidez , Doenças Sexualmente Transmissíveis/complicações , Adolescente , Adulto , Infecções por Chlamydia/complicações , Chlamydia trachomatis , Estudos Transversais , Feminino , Gonorreia/complicações , Humanos , Lactente , Recém-Nascido , Pessoa de Meia-Idade , Gravidez , Estudos Retrospectivos , Fatores de Risco , Sífilis/complicações , Adulto Jovem
18.
J Acquir Immune Defic Syndr ; 77(4): 383-392, 2018 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-29239901

RESUMO

BACKGROUND: No randomized trial has directly compared the efficacy of prolonged infant antiretroviral prophylaxis versus maternal antiretroviral therapy (mART) for prevention of mother-to-child transmission throughout the breastfeeding period. SETTING: Fourteen sites in Sub-Saharan Africa and India. METHODS: A randomized, open-label strategy trial was conducted in HIV-1-infected women with CD4 counts ≥350 cells/mm (or ≥country-specific ART threshold if higher) and their breastfeeding HIV-1-uninfected newborns. Randomization at 6-14 days postpartum was to mART or infant nevirapine (iNVP) prophylaxis continued until 18 months after delivery or breastfeeding cessation, infant HIV-1 infection, or toxicity, whichever occurred first. The primary efficacy outcome was confirmed infant HIV-1 infection. Efficacy analyses included all randomized mother-infant pairs except those with infant HIV-1 infection at entry. RESULTS: Between June 2011 and October 2014, 2431 mother-infant pairs were enrolled; 97% of women were World Health Organization Clinical Stage I, median screening CD4 count 686 cells/mm. Median infant gestational age/birth weight was 39 weeks/2.9 kilograms. Seven of 1219 (0.57%) and 7 of 1211 (0.58%) analyzed infants in the mART and iNVP arms, respectively, were HIV-infected (hazard ratio 1.0, 96% repeated confidence interval 0.3-3.1); infant HIV-free survival was high (97.1%, mART and 97.7%, iNVP, at 24 months). There were no significant differences between arms in median time to breastfeeding cessation (16 months) or incidence of severe, life-threatening, or fatal adverse events for mothers or infants (14 and 42 per 100 person-years, respectively). CONCLUSIONS: Both mART and iNVP prophylaxis strategies were safe and associated with very low breastfeeding HIV-1 transmission and high infant HIV-1-free survival at 24 months.


Assuntos
Fármacos Anti-HIV/uso terapêutico , Aleitamento Materno , Quimioprevenção/métodos , Infecções por HIV/prevenção & controle , Infecções por HIV/transmissão , Transmissão Vertical de Doença Infecciosa/prevenção & controle , África ao Sul do Saara , Pré-Escolar , Feminino , Infecções por HIV/tratamento farmacológico , Infecções por HIV/patologia , Humanos , Índia , Lactente , Recém-Nascido , Período Pós-Parto , Resultado do Tratamento
19.
Clin Infect Dis ; 66(11): 1770-1777, 2018 05 17.
Artigo em Inglês | MEDLINE | ID: mdl-29272365

RESUMO

Background: The presence of antiretroviral drug-associated resistance mutations (DRMs) may be particularly problematic in human immunodeficiency virus (HIV)-infected pregnant women as it can lead to mother-to-child transmission (MTCT) of resistant HIV strains. This study evaluated the prevalence and the effect of antiretroviral DRMs in previously untreated mother-infant pairs. Methods: A case-control design of 1:4 (1 transmitter to 4 nontransmitters) was utilized to evaluate DRMs as a predictor of HIV MTCT in specimens obtained from mother-infant pairs. ViroSeq HIV-1 genotyping was performed on mother-infant specimens to assess for clinically relevant DRMs. Results: One hundred forty infants acquired HIV infection; of these, 123 mother-infant pairs (88%) had specimens successfully amplified using ViroSeq and assessed for drug resistance genotyping. Additionally, 483 of 560 (86%) women who did not transmit HIV to infants also had samples evaluated for DRMs. Sixty-three of 606 (10%) women had clinically relevant DRMs; 12 (2%) had DRMs against >1 drug class. Among 123 HIV-infected infants, 13 (11%) had clinically relevant DRMs, with 3 (2%) harboring DRMs against >1 drug class. In univariate and multivariate analyses, DRMs in mothers were not associated with increased HIV MTCT (adjusted odds ratio, 0.8 [95% confidence interval, .4-1.5]). Presence of DRMs in transmitting mothers was strongly associated with DRM presence in their infants (P < .001). Conclusions: Preexisting DRMs were common in untreated HIV-infected pregnant women, but did not increase the risk of HIV MTCT. However, if women with DRMs are not virologically suppressed, they may transmit resistant mutations, thus complicating infant management.


Assuntos
Fármacos Anti-HIV/farmacologia , Farmacorresistência Viral Múltipla , Infecções por HIV/virologia , HIV-1/efeitos dos fármacos , Transmissão Vertical de Doença Infecciosa , Adolescente , Adulto , Fármacos Anti-HIV/classificação , Feminino , Infecções por HIV/transmissão , HIV-1/genética , Humanos , Lactente , Mutação , Gravidez , Adulto Jovem
20.
HIV Clin Trials ; 19(6): 209-224, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30890061

RESUMO

BACKGROUND: IMPAACT PROMISE 1077BF/FF was a randomized study of antiretroviral therapy (ART) strategies for pregnant and postpartum women with high CD4+ T-cell counts. We describe postpartum outcomes for women in the study who were randomized to continue or discontinue ART after delivery. METHODS: Women with pre-ART CD4+ cell counts ≥350 cells/mm3 who started ART during pregnancy were randomized postpartum to continue or discontinue treatment. Women were enrolled from India, Malawi, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe. The primary outcome was a composite of progression to AIDS-defining illness or death. Log-rank tests and Cox regression models assessed treatment effects. Incidence rates were calculated per 100 person-years. A post hoc analysis evaluated WHO Stage 2/3 events. All analyses were intent-to-treat. FINDINGS: 1611 women were enrolled (June 2011-October 2014) and 95% were breastfeeding. Median age at entry was 27 years, CD4+ count 728 cells/mm3 and the majority of women were Black African (97%). After a median follow-up of 1.6 years, progression to AIDS-defining illness or death was rare and there was no significant difference between arms (HR: 0·55; 95%CI 0·14, 2·08, p = 0.37). WHO Stage 2/3 events were reduced with continued ART (HR: 0·60; 95%CI 0·39, 0·90, p = 0.01). The arms did not differ with respect to the rate of grade 2, 3, or 4 safety events (p = 0.61). INTERPRETATION: Serious clinical events were rare among predominately breastfeeding women with high CD4+ cell counts over 18 months after delivery. ART had significant benefit in reducing WHO 2/3 events in this population.


Assuntos
Fármacos Anti-HIV/uso terapêutico , Terapia Antirretroviral de Alta Atividade , Infecções por HIV/tratamento farmacológico , Saúde Materna , Adulto , Aleitamento Materno , Contagem de Linfócito CD4 , Progressão da Doença , Feminino , Infecções por HIV/virologia , Humanos , Período Pós-Parto , Gravidez , Resultado do Tratamento , Adulto Jovem
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