Midtrimester bacterial vaginosis and cervical length in women at risk for preterm birth.

OBJECTIVE: The purpose of this study was to estimate the effect of bacterial vaginosis on midtrimester cervical length in women at increased risk for recurrent spontaneous preterm birth. STUDY DESIGN: We conducted a secondary analysis of prerandomization data from a multicenter trial of ultrasound-indicated cerclage. Women with previous spontaneous preterm birth at <34 weeks' gestation underwent initial cervical length assessment and vaginal fluid collection at 16-21 weeks 6 days gestation. Gram stains were scored with Nugent criteria. With serial scans, the shortest cervical length was observed. RESULTS: Records for 949 women had complete data. In unadjusted regression models, Nugent score (P = .003) and vaginal fluid pH (P = .008) were related inversely to cervical length. Women with bacterial vaginosis based on Nugent score ≥7 (P = .04) or pH ≥5 (P = .016) had significantly lower cervical length than unaffected women; however, all of these effects were null after covariate adjustment. CONCLUSION: Nugent score, pH level, and bacterial vaginosis are associated inversely with cervical length; however, these relationships become null after adjustment for relevant covariates.

Does midtrimester Nugent score or high vaginal pH predict gestational age at delivery in women at risk for recurrent preterm birth?

OBJECTIVE: To estimate whether bacterial vaginosis, as defined by either Nugent score or vaginal pH, predicts gestational age at delivery in women at risk for recurrent preterm birth. STUDY DESIGN: Planned secondary analysis of a randomized cerclage trial in women with prior spontaneous preterm birth 17°(/)7-336(/)7 weeks. Vaginal Gram stain and pH were collected at the initial study visit. Women not assigned to cerclage, either because they did not experience cervical shortening <25 mm or because they were randomly assigned to no cerclage, were studied. RESULTS: Seven hundred eighty-six women had complete delivery gestational age, Gram stain, and pH results. The diagnosis of bacterial vaginosis by either Nugent score ≥ 7 or by pH ≥ 5 was not associated with earlier birth. CONCLUSION: The presence of bacterial vaginosis at 16-216(/)7 weeks does not predict gestational age at birth in women at risk for recurrent preterm birth.

17-alpha-hydroxyprogesterone caproate for the prevention of preterm birth in women with prior preterm birth and a short cervical length.

OBJECTIVE: We sought to evaluate 17-alpha-hydroxyprogesterone caproate (17P) for prevention of preterm birth (PTB) in women with prior spontaneous PTB (SPTB) and cervical length (CL) <25 mm. STUDY DESIGN: We conducted planned secondary analysis of the Eunice Kennedy Shriver National Institute of Child Health and Human Development-sponsored randomized trial evaluating cerclage for women with singleton gestations, prior SPTB (17-33 6/7 weeks), and CL <25 mm between 16-22 6/7 weeks. Women were stratified at randomization to intent to use or not use 17P. The effect of 17P was analyzed separately for cerclage and no-cerclage groups. Primary outcome was PTB <35 weeks. RESULTS: In 300 women, 17P had no effect on PTB <35 weeks in either cerclage (P = .64) or no-cerclage (P = .51) groups. Only PTB <24 weeks (odds ratio, 0.08) and perinatal death (odds ratio, 0.14) were significantly lower for those with 17P in the no-cerclage group. CONCLUSION: 17P had no additional benefit for prevention of PTB in women who had prior SPTB and got ultrasound-indicated cerclage for CL <25 mm. In women who did not get cerclage, 17P reduced previable birth and perinatal mortality.

Wound morbidity with staples compared with suture for cesarean skin closure by diabetic status.

OBJECTIVE: To determine if the risk of post-cesarean wound morbidity in patients undergoing staple versus suture closure is modified by diabetic status. METHODS: Secondary analysis of a randomized trial of skin closure with subcuticular 4-0 monocryl suture or surgical staples after cesarean delivery. The primary outcome was a composite of wound disruption or infection within 4-6 weeks. We compared the association between this outcome and skin closure method by diabetic status (also stratified by gestational or pregestational) using the Breslow-Day test for interaction. RESULTS: Of 350 patients, 179 were randomized to staples and 171 to suture. Of the 67 (19.1%) diabetic patients, 35 were gestational and 32 pregestational. The incidence of composite wound morbidity in non-diabetics was 16.7% for staples and 3.6% for suture (p ≤ 0.001, RR: 4.6, 95% CI: 1.8-11.8); it was 5.7% for staples and 15.6% for sutures in diabetics (p = 0.25, RR: 0.4, 95% CI: 0.1-1.7). The corresponding Breslow-Day p value indicated a significant difference between diabetics and non-diabetics (p = 0.002). Stratified further by gestational and pregestational diabetes, the RRs were 0.3 (95% CI: 0.03-2.4) and 0.5 (95% CI: 0.05-5.0) compared to non-diabetics, respectively. Each diabetic sub-group was significantly different from non-diabetics (Breslow-Day p values for homogeneity p = 0.005 and p = 0.045, respectively). CONCLUSIONS: The use of staples compared with subcuticular suture for cesarean skin closure is associated with increased wound morbidity. While this is true for non-diabetics, further studies of diabetics are needed to evaluate for a null or opposite effect of closure type.

Risk factors for wound disruption following cesarean delivery.

OBJECTIVE: Risk factors for post-cesarean wound infection, but not disruption, are well-described in the literature. The primary objective of this study was to identify risk factors for non-infectious post-cesarean wound disruption. METHODS: Secondary analysis was conducted using data from a single-center randomized controlled trial of staple versus suture skin closure in women ≥24 weeks' gestation undergoing cesarean delivery. Wound disruption was defined as subcutaneous skin or fascial dehiscence excluding primary wound infections. Composite wound morbidity (disruption or infection) was examined as a secondary outcome. Patient demographics, medical co-morbidities, and intrapartum characteristics were evaluated as potential risk factors using multivariable logistic regression. RESULTS: Of the 398 randomized patients, 340, including 26 with disruptions (7.6%) met inclusion criteria and were analyzed. After multivariable adjustments, African-American race (aOR 3.9, 95% CI 1.1-13.8) and staple - as opposed to suture - wound closure (aOR 5.4, 95% CI 1.8-16.1) remained significant risk factors for disruption; non-significant increases were observed for body mass index ≥30 (aOR 2.1, 95% CI 0.6-7.5), but not for diabetes mellitus (aOR 0.9, 95% CI 0.3-2.9). RESULTS for composite wound morbidity were similar. CONCLUSIONS: Skin closure with staples, African-American race, and considering the relatively small sample size, potentially obesity are associated with increased risk of non-infectious post-cesarean wound disruption.

Surgical staples compared with subcuticular suture for skin closure after cesarean delivery: a randomized controlled trial.

OBJECTIVE: To compare the risk of cesarean wound disruption or infection after closure with surgical staples compared with subcuticular suture. METHODS: Women with viable pregnancies at 24 weeks of gestation or greater undergoing scheduled or unscheduled cesarean delivery were randomized to wound closure with surgical staples or absorbable suture. Staples were removed at postoperative days 3-4 for low transverse incisions and days 7-10 for vertical incisions. Standardized wound evaluations were performed at discharge (days 3-4) and 4-6 weeks postoperatively. The primary outcome was a composite of wound disruption or infection within 4-6 weeks. Secondary outcomes included operative time, highest pain score on analog scale, cosmesis score, and patient scar satisfaction score. Analyses were by intent to treat. RESULTS: Of 398 patients, 198 were randomized to staples and 200 to suture (but four received staples). Baseline characteristics including body mass index, prior cesarean delivery, labor, and type of skin incision were similar by group. The primary outcome incidence at hospital discharge was 7.1% for staples and 0.5% for suture (P<.001, relative risk 14.1, 95% confidence interval [CI] 1.9-106). Of 350 (87.9%) with follow-up at 4-6 weeks, the cumulative risk of the primary outcome at 4-6 weeks was 14.5% for staples and 5.9% for suture (P=.008, relative risk 2.5, 95% CI 1.2-5.0). Operative time was longer with suture closure (median time of 58 versus 48 minutes; P<.001). Pain scores at 72-96 hours and at 6 weeks, cosmesis score, and patient satisfaction score did not differ by group. CONCLUSION: Staples closure compared with suture is associated with significantly increased composite wound morbidity after cesarean delivery. CLINICAL TRIAL REGISTRATION: : ClinicalTrials.gov, www.clinicaltrials.gov, NCT01008449. LEVEL OF EVIDENCE: : I.

Relationship between 1-hour glucose challenge test results and perinatal outcomes.

OBJECTIVE: To estimate the relationship between 1-hour 50 g glucose challenge test values and perinatal outcomes. METHODS: This was a secondary analysis of data from a multicenter treatment trial of mild gestational diabetes mellitus. Women with glucose challenge test values of 135-199 mg/dL completed a 3-hour oral glucose tolerance test. Mild gestational diabetes mellitus was defined as fasting glucose less than 95 mg/dL and two or more abnormal oral glucose tolerance test values: 1-hour 180 mg/dL or more; 2-hour 155 mg/dL or more; and 3-hour 140 mg/dL or more. Our study included untreated women with glucose challenge test values of 135-139 mg/dL and 140-199 mg/dL and a comparison group with values less than 120 mg/dL. Primary outcomes included a perinatal composite (stillbirth, neonatal death, hypoglycemia, hyperbilirubinemia, neonatal hyperinsulinemia, and birth trauma), large for gestational age (LGA, birth weight above the 90 percentile based on sex-specific and race-specific norms), and macrosomia (greater than 4,000 g). RESULTS: There were 436 women with glucose challenge test values less than 120 mg/dL and 1,403 with values of 135 mg/dL or more (135-139, n=135; 140-199, n=1,268). The composite perinatal outcome occurred in 25.6% of those with glucose challenge test values less than 120 mg/dL compared with 21.1% for values of 135-139 mg/dL and 35.3% for values of 140-199 mg/dL. Rates of LGA by group were 6.6%, 6.8%, and 12.4%, respectively. Rates of macrosomia by group were 7.8%, 6.1%, and 12.1%, respectively. Compared with glucose challenge test values less than 120 mg/dL, the adjusted odds ratios (ORs) (95% confidence intervals [CIs]) for values of 140-199 mg/dL were 1.48 (1.14-1.93) for the composite outcome, 1.97 (1.29-3.11) for LGA, and 1.61 (1.07-2.49) for macrosomia. For glucose challenge test values of 135-139 mg/dL, adjusted ORs and 95% CIs were 0.75 (0.45-1.21), 1.04 (0.44-2.24), and 0.75 (0.30-1.66), respectively. The subcategories with glucose challenge test values of 140-144 mg/dL and 145-149 mg/dL also were associated with an increase in selected outcomes when compared with those with values less than 120 mg/dL. CONCLUSIONS: Glucose challenge test values of 135-139 mg/dL were not associated with adverse outcomes compared with values less than 120 mg/dL; however, glucose challenge test values of 140 mg/dL or more were associated with an increase in odds of the composite perinatal outcome, LGA, and macrosomia.

Higher-dose oxytocin and hemorrhage after vaginal delivery: a randomized controlled trial.

OBJECTIVE: Higher-dose oxytocin is more effective than lower-dose regimens to prevent postpartum hemorrhage after cesarean delivery. We compared two higher-dose regimens (80 units and 40 units) to our routine regimen (10 units) among women who delivered vaginally. METHODS: In a double-masked randomized trial, oxytocin (80 units, 40 units, or 10 units) was administered in 500 mL over 1 hour after placental delivery. The primary outcome was a composite of any treatment of uterine atony or hemorrhage. Prespecified secondary outcomes included outcomes in the primary composite and a decline of 6% or more in hematocrit. A sample size of 600 per group (N=1,800) was planned to compare each of the 80-unit and 40-unit groups to the 10-unit group. At planned interim review (n=1,201), enrollment in the 40-unit group was stopped for futility and enrollment continued in the other groups. RESULTS: Of 2,869 women, 1,798 were randomized as follows: 658 to 80 units; 481 to 40 units; and 659 to 10 units. Most characteristics were similar across groups. The risk of the primary outcome in the 80-unit group (6%; relative risk [RR] 0.93, 95% confidence interval [CI] 0.62-1.40) or the 40-unit group (6%; RR 0.94, 95% CI 0.61-1.47) was not different compared with the 10-unit group (7%). Treatment with additional oxytocin after the first hour was less frequent with 80 units compared with 10 units (RR 0.41, 95% CI 0.19-0.88), as was a 6% or more decline in hematocrit (RR 0.83, 95% CI 0.69-0.99); both outcomes declined with increasing oxytocin dose. Outcomes were similar between the 40-unit and 10-unit groups. CONCLUSION: Compared with 10 units, 80 units or 40 units of prophylactic oxytocin did not reduce overall postpartum hemorrhage treatment when administered in 500 mL over 1 hour for vaginal delivery. Eighty units decreased the need for additional oxytocin and the risk of a decline in hematocrit of 6% or more. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00790062. LEVEL OF EVIDENCE: I.

[Circulation of a different lineage of dengue virus serotype 2 American / Asian genotype in the Peruvian Amazon, 2010]. / Circulación de un linaje diferente del virus dengue 2 genotipo América / Asia en la región amazónica de Perú, 2010.

Our objective was to determine the genotype of the dengue virus type 2 (DENV-2) that circulated in the Amazon region of Peru between November 2010 and January 2011. We analyzed eight samples collected during dengue surveillance activities in the cities of Iquitos, Yurimaguas, Trujillo, Tarapoto and Lima between November 2010 and January 2011 that were sent to Insitituto Nacional de Salud. The viruses were isolated in C6/36 HT cell line. Viral RNA was extracted and the serotype (RT - PCR multiplex) and genotype (RT-Nested PCR of the region E/NS1) were determined. Finally, the E/ NS1 amplicons were sequenced and analyzed by phylogeny. The phylogenetic analysis revealed the introduction of a different lineage which entered in Peru by the end of 2010. These isolates found in Iquitos and other cities in Peru are closely related to DENV-2 isolates that circulated in Brazil during 2007 and 2008, associated with severe dengue cases and deaths. In conclusion, we detected the introduction of a different lineage of DENV-2 America / Asia genotype in Peru that could be associated with the presence of more severe cases.

[Concurrent infections by two dengue virus serotypes during an outbreak in northwestern Peru, 2008]. / Infecciones concurrentes por dos serotipos del virus dengue durante un brote en el noroeste de Perú, 2008.

OBJECTIVES: To establish the existence of concurrent infections by different dengue virus (DENV) serotypes in an outbreak in the Northwestern in Peru during 2008. MATERIAL AND METHODS: 73 serum samples from patients with dengue were analyzed during an outbreak that occurred in Northwestern in Peru between May and June 2008. Molecular biology techniques were used to serotype the DENV, thus, firstly the viral RNA viral was extracted using Viral QIAamp RNA mini kit (Qiagen, Valencia, California, USA), then the viral cDNA fragments were reverse transcripted and amplified by means of the Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and the RT-Nested PCR region techniques and finally, genetic sequencing of the viral cDNA fragments were performed using the Big Dye Terminator v.3,1 kit. RESULTS: The 73 dengue cases presented infections by different serotypes: 34 (46.6%) by DENV-3, 29 (39.7%) by DENV-1, 4 (5.5%) by DENV-4, and 6 (8.2%) concurrent infections by DENV-1 and DENV-3. The most frequent clinical manifestations observed among dengue patients were fever and headache (100%), myalgia (94.5%), ocular pain (83.6%), arthralgia (78.1%), shivers (63.0%), nausea/vomiting (38.4%), positive tourniquet test (30.1%), and rash (20.5%). All patients with concurrent infections presented light clinical course of dengue fever (DF) except one patient who had moderate hemorrhagic manifestations. CONCLUSION: This is the first Peruvian report of patients with concurrent infections of two DENV serotypes without severe clinical manifestations.

Circulación de un linaje diferente del virus dengue 2 genotipo América / Asia en la región amazónica de Perú, 2010 / Circulation of a different lineage of dengue virus serotype 2 American / Asian genotype in the Peruvian amazon, 2010

El objetivo del estudio fue determinar el genotipo del virus dengue tipo 2 (DENV-2) que circuló en la región Amazónica de Perú entre noviembre de 2010 y enero de 2011. Se analizaron ocho muestras de pacientes captados durante la vigilancia para dengue en las ciudades de Iquitos, Yurimaguas, Trujillo, Tarapoto y Lima entre noviembre de 2010 y enero de 2011 que fueron remitidas al Instituto Nacional de Salud. Se realizó el aislamiento viral en la línea C6/36 HT y la extracción del ARN viral. Se aplicaron técnicas de biología molecular para establecer el serotipo (RT - PCR múltiple) y genotipo (RT-Nested PCR de la región E/NS1) seguidas de secuenciación y análisis filogenético. El análisis filogenético reveló la introducción de un linaje diferente que ingresó a Perú a finales del 2010. Estos aislamientos encontrados en Iquitos y otras ciudades de Perú están muy relacionados con aislamientos de DENV-2 que circularon en Brasil durante el 2007 y 2008 asociados con casos de dengue grave y muertes. En conclusión se detectó la introducción de un linaje diferente del DENV-2 genotipo América/Asia en Perú que podría estar asociado con la presencia de casos más graves de dengue.

Our objective was to determine the genotype of the dengue virus type 2 (DENV-2) that circulated in the Amazon region of Peru between November 2010 and January 2011. We analyzed eight samples collected during dengue surveillance activities in the cities of Iquitos, Yurimaguas, Trujillo, Tarapoto and Lima between November 2010 and January 2011 that were sent to Insitituto Nacional de Salud. The viruses were isolated in C6/36 HT cell line. Viral RNA was extracted and the serotype (RT - PCR multiplex) and genotype (RT-Nested PCR of the region E/NS1) were determined. Finally, the E/ NS1 amplicons were sequenced and analyzed by phylogeny. The phylogenetic analysis revealed the introduction of a different lineage which entered in Peru by the end of 2010. These isolates found in Iquitos and other cities in Peru are closely related to DENV-2 isolates that circulated in Brazil during 2007 and 2008, associated with severe dengue cases and deaths. In conclusion, we detected the introduction of a different lineage of DENV-2 America / Asia genotype in Peru that could be associated with the presence of more severe cases.

Infecciones concurrentes por dos serotipos del virus dengue durante un brote en el noroeste de Perú, 2008 / Concurrent infections by two dengue virus serotypes during an outbreak in northwestern Peru, 2008

Objetivo. Describir la existencia de infecciones concurrentes por diferentes serotipos del virus dengue (DENV) enun brote ocurrido en el noroeste de Perú durante el 2008. Materiales y métodos. Se analizó 73 muestras séricas de pacientes con dengue en un brote en el noroeste de Perú entre mayo y junio de 2008. Para la serotipificación del DENV se utilizó técnicas de biología molecular; así, primero se realizó la extracción del ARN con el kit QIAamp viral RNA Mini, luego se realizó la transcripción inversa y amplificación de los fragmentos de ADNc viral mediante las técnicas de reacción en cadena de la polimerasa con transcriptasa inversa (RT-PCR multiplex) y de RT-Anidada PCR(RT-Nested PCR), y finalmente de realizó el secuenciamiento genético de los fragmentos de ADNc viral utilizando el kit Big Dye Terminator v.3,1. Resultados. Los 73 casos de dengue presentaron infecciones por diferentes serotipos: 34 (46,6%) por DENV-3, 29 (39,7 por ciento) por DENV-1, 4 (5,5 por ciento) por DENV-4 y 6 casos (8,2 por ciento) por DENV-1 y DENV-3. Las manifestaciones clínicas más frecuentes fueron fiebre y cefalea (100 por ciento), mialgia (94,5 por ciento), dolor ocular (83,6 por ciento ), artralgia (78,1 por ciento), escalofríos (63,0 por ciento), nauseas/vómitos (38,4 por ciento), prueba de lazo positiva (30,1 por ciento) y erupción cutánea (20,5 por ciento). Los pacientes con infecciones concurrentes presentaron cuadros leves, excepto una paciente que presentó prueba de lazo positivo y sangrado genital. Conclusión. Es el primer reporte de pacientes peruanos con infecciones concurrentes por dos serotipos del DENV sin formas graves de la enfermedad.

Objetives. To establish the existence of concurrent infections by different dengue virus (DENV) serotypes in an outbreak in the Northwestern in Peru during 2008. Material and methods. 73 serum samples from patients with dengue were analyzed during an outbreak that occurred in Northwestern in Peru between May and June 2008. Molecular biology techniques were used to serotype the DENV, thus, firstly the viral RNA viral was extracted using Viral QIAamp RNA mini kit (Qiagen, Valencia, California, USA), then the viral cDNA fragments were reverse transcripted and amplified by means of the Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and the RT-Nested PCR region techniques and finally, genetic sequencing of the viral cDNA fragments were performed using the Big Dye Terminator v.3,1 kit. Results. The 73 dengue cases presented infections by different serotypes: 34 (46.6 per cent) by DENV-3, 29 (39.7 per cent) by DENV-1, 4 (5.5 per cent) by DENV-4, and 6 (8.2 per cent) concurrent infections by DENV-1 and DENV-3. The most frequent clinical manifestations observed among dengue patients were fever and headache (100 per cent), myalgia (94.5 per cent), ocular pain (83.6 per cent), arthralgia (78.1 per cent), shivers(63.0 per cent), nausea/vomiting (38.4 per cent), positive tourniquet test (30.1 per cent), and rash (20.5 per cent). All patients with concurrent infections presented light clinical course of dengue fever (DF) except one patient who had moderate hemorrhagic manifestations. Conclusion. This is the first Peruvian report of patients with concurrent infections of two DENV serotypes without severe clinical manifestations.