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  • 1
    In: Obstetrical & Gynecological Survey, Ovid Technologies (Wolters Kluwer Health), Vol. 74, No. 1 ( 2019-1), p. 7-9
    Abstract: (Abstracted from N Engl J Med 2018;379:513–523) The perinatal and maternal consequences of induction of labor at 39 weeks among low-risk nulliparous women are uncertain. The ARRIVE trial (A Randomized Trial of Induction Versus Expectant Management) was designed to test the hypothesis that elective induction of labor at 39 weeks would result in a lower risk of a composite outcome of perinatal death or severe neonatal complications than expectant management among low-risk nulliparous women.
    Type of Medium: Online Resource
    ISSN: 1533-9866 , 0029-7828
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2019
    detail.hit.zdb_id: 2043471-6
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  • 2
    In: American Journal of Obstetrics & Gynecology MFM, Elsevier BV, Vol. 4, No. 4 ( 2022-07), p. 100641-
    Type of Medium: Online Resource
    ISSN: 2589-9333
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2022
    detail.hit.zdb_id: 2988319-2
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  • 3
    In: Obstetrics & Gynecology, Ovid Technologies (Wolters Kluwer Health), Vol. 135, No. 3 ( 2020-03), p. 583-590
    Abstract: To estimate whether maternal sense of control in labor is associated with breastfeeding at 4–8 weeks postpartum. METHODS: This is a secondary analysis of data from a multicenter randomized controlled trial of elective induction of labor at 39 weeks of gestation in low-risk nulliparous women. In this trial, women completed the Labor Agentry Scale, a validated measure of women's feelings of control over the childbirth process, 6–96 hours after delivery. The Labor Agentry Scale score, which is higher with more perceived control during childbirth, was analyzed both as a continuous and a categorical variable (quintiles). Self-reported breastfeeding at 4–8 weeks postpartum was categorized as exclusive breastfeeding, breastfeeding and formula feeding, or exclusive formula feeding. Women were included in this analysis if they labored, filled out a Labor Agentry Scale questionnaire, had a neonate who survived until the postpartum visit, and provided information on infant feeding. Multinomial logistic regression was used to adjust for confounders. RESULTS: Of 5,185 women, 32.9% (n=1,705) were exclusively breastfeeding, 31.2% (n=1,620) were breastfeeding and formula feeding, and 35.9% (n=1,860) were exclusively formula feeding 4–8 weeks after delivery. Overall Labor Agentry Scale score ranged from 34 to 203 (median 167, interquartile range 145–182). The median Labor Agentry Scale score was 169 (interquartile range 151–183) for women exclusively breastfeeding, 166 (interquartile range 142–182) for women who were breastfeeding and formula feeding, and 164 (interquartile range 142–181) for women who were only formula feeding ( P 〈 .001). In the unadjusted multinomial model, women with Labor Agentry Scale scores in the lowest two quintiles (ie, those with lower perceived control during childbirth) were less likely to be exclusively breastfeeding (as compared with those exclusively formula feeding) than women in the highest Labor Agentry Scale quintile. When controlling for confounders, however, this association was no longer significant. CONCLUSION: After adjustment for confounders, perceived control during childbirth was not associated with breastfeeding at 4–8 weeks postpartum among nulliparous women. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01990612.
    Type of Medium: Online Resource
    ISSN: 0029-7844
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2020
    detail.hit.zdb_id: 2012791-1
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  • 4
    In: American Journal of Perinatology, Georg Thieme Verlag KG
    Abstract: Objective The objective of this study is to evaluate whether there is an association between in-utero exposure to nicotine and subsequent hearing dysfunction. Patients and Methods Secondary analysis of a multicenter randomized trial to prevent congenital cytomegalovirus (CMV) infection among gravidas with primary CMV infection was conducted. Monthly intravenous immunoglobulin hyperimmune globulin therapy did not influence the rate of congenital CMV. Dyads with missing urine, fetal or neonatal demise, infants diagnosed with a major congenital anomaly, congenital CMV infection, or with evidence of middle ear dysfunction were excluded. The primary outcome was neonatal hearing impairment in one or more ears defined as abnormal distortion product otoacoustic emissions (DPOAEs; 1 to 8 kHz) that were measured within 42 days of birth. DPOAEs were interpreted using optimized frequency-specific level criteria. Cotinine was measured via enzyme-linked immunosorbent assay kits in maternal urine collected at enrollment and in the third trimester (mean gestational age 16.0 and 36.7 weeks, respectively). Blinded personnel ran samples in duplicates. Maternal urine cotinine 〉 5 ng/mL at either time point was defined as in-utero exposure to nicotine. Multivariable logistic regression included variables associated with the primary outcome and with the exposure (p  〈  0.05) in univariate analysis. Results Of 399 enrolled patients in the original trial, 150 were included in this analysis, of whom 46 (31%) were exposed to nicotine. The primary outcome occurred in 18 (12%) newborns and was higher in nicotine-exposed infants compared with those nonexposed (15.2 vs. 10.6%, odds ratio [OR] 1.52, 95% confidence interval [CI] 0.55–4.20), but the difference was not significantly different (adjusted odds ratio [aOR] = 1.0, 95% CI 0.30–3.31). This association was similar when exposure was stratified as heavy ( 〉 100 ng/mL, aOR 0.72, 95% CI 0.15–3.51) or mild (5–100 ng/mL, aOR 1.28, 95% CI 0.33–4.95). There was no association between nicotine exposure and frequency-specific DPOAE amplitude. Conclusion In a cohort of parturients with primary CMV infection, nicotine exposure was not associated with offspring hearing dysfunction assessed with DPOAEs. Key Points
    Type of Medium: Online Resource
    ISSN: 0735-1631 , 1098-8785
    Language: English
    Publisher: Georg Thieme Verlag KG
    Publication Date: 2022
    detail.hit.zdb_id: 2042426-7
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  • 5
    In: Obstetrical & Gynecological Survey, Ovid Technologies (Wolters Kluwer Health), Vol. 77, No. 1 ( 2022-1), p. 16-18
    Abstract: (Abstracted from N Engl J Med 2021;385:436–444) Congenital cytomegalovirus (CMV) infections are associated with stillbirth, neonatal death, deafness, and cognitive and motor delay. Small observational studies have evaluated CMV hyperimmune globulin to prevent congenital infection in women with primary CMV infection during pregnancy; however, the results were either inconsistent or inconclusive.
    Type of Medium: Online Resource
    ISSN: 1533-9866 , 0029-7828
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2022
    detail.hit.zdb_id: 2043471-6
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  • 6
    In: New England Journal of Medicine, Massachusetts Medical Society, Vol. 385, No. 5 ( 2021-07-29), p. 436-444
    Type of Medium: Online Resource
    ISSN: 0028-4793 , 1533-4406
    RVK:
    Language: English
    Publisher: Massachusetts Medical Society
    Publication Date: 2021
    detail.hit.zdb_id: 1468837-2
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  • 7
    In: Obstetrics & Gynecology, Ovid Technologies (Wolters Kluwer Health), Vol. 136, No. 4 ( 2020-10), p. 698-705
    Abstract: To develop models to predict vaginal delivery in low-risk, nulliparous women contemplating elective induction of labor or expectant management at 39 weeks of gestation. METHODS: We conducted a secondary analysis of a randomized controlled trial of planned elective induction of labor at 39 weeks of gestation compared with expectant management for low-risk nulliparous women. Two groups were included for this analysis: 1) women who were randomized to the induction of labor group and underwent elective induction at 39 0/7–39 4/7 weeks of gestation and 2) women who were randomized to the expectant management group who experienced spontaneous labor or medically indicated delivery (including postterm). Multivariable logistic regression models were developed for each group using patient characteristics that would be available at the time of counseling. Model selection was based on k-fold cross-validation using backward elimination and variables that remained significant at P 〈 .05 were retained. To compare estimated with observed rates, the elective induction of labor model was then applied to each woman in both groups to estimate individualized predicted probabilities of vaginal delivery with elective induction of labor. RESULTS: Of 6,106 women enrolled in the trial, 4,661 met criteria for this analysis. Vaginal delivery occurred in 80.6% of the 2,153 women in the elective induction of labor group and 77.2% of the 2,508 women in the expectant management group ( P =.005). The final elective induction of labor model included age, height, weight, and modified Bishop score (area under the receiver operating characteristic curve [AUROC] 0.72, 95% CI 0.70–0.75). The same variables were included in the final expectant management model (AUROC 0.70, 95% CI 0.67–0.72). Across the range of predicted probability deciles derived from the elective induction of labor model, almost all women who underwent elective induction of labor at 39 weeks of gestation had a higher observed chance of vaginal delivery than expectant management. CONCLUSION: Irrespective of the individual predicted chance of vaginal delivery from elective induction of labor at 39 weeks of gestation, vaginal delivery is generally more frequent if elective induction of labor is undertaken rather than expectant management. These data can be used to counsel nulliparous women regarding their “customized” chances of vaginal delivery as they choose between elective induction of labor or expectant management at 39 weeks of gestation. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01990612.
    Type of Medium: Online Resource
    ISSN: 0029-7844
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2020
    detail.hit.zdb_id: 2012791-1
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  • 8
    In: Obstetrics & Gynecology, Ovid Technologies (Wolters Kluwer Health), Vol. 139, No. 3 ( 2022-03), p. 400-406
    Abstract: To develop and internally validate a noninvasive method for the prediction of congenital cytomegalovirus (CMV) infection after primary maternal CMV infection. METHODS: We conducted a secondary analysis of a multicenter randomized placebo-controlled trial of CMV hyperimmune globulin to prevent congenital infection. Women were eligible if they had primary CMV infection, defined as detectable plasma CMV-specific immunoglobulin (Ig)M and CMV-specific IgG with avidity less than 50% before 24 weeks of gestation or IgG seroconversion before 28 weeks, and were carrying a singleton fetus without ultrasonographic findings suggestive of CMV infection. Antibody assays were performed in a single reference laboratory. Congenital infection was defined as CMV detection in amniotic fluid, neonatal urine or saliva, or postmortem tissue. Using backward elimination, we developed logit models for prediction of congenital infection using factors known at randomization. The performance of the model was assessed using leave-one-out cross-validation (a method of internal validation). RESULTS: Of 399 women enrolled in the trial, 344 (86%) had informative data for this analysis. Congenital infection occurred in 68 pregnancies (20%). The best performing model included government-assisted insurance, IgM index 4.5 or higher, IgG avidity less than 32%, and whether CMV was detectable by polymerase chain reaction in maternal plasma at the time of randomization. Cross-validation showed an average area under the curve of 0.76 (95% CI 0.70–0.82), indicating moderate discriminatory ability. More parsimonious one-, two-, and three-factor models performed significantly less well than the four-factor model. Examples of prediction with the four-factor model: for a woman with government-assisted insurance, avidity less than 32%, IgM index 4.5 or higher, and detectable plasma CMV, probability of congenital infection was 0.69 (95% CI 0.53–0.82); for a woman with private insurance, avidity 32% or greater, IgM index less than 4.5, and undetectable plasma CMV, probability of infection was 0.03 (95% CI 0.02–0.07). CONCLUSION: We developed models to predict congenital CMV infection in the presence of primary maternal CMV infection and absence of ultrasonographic findings suggestive of congenital infection. These models may be useful for patient counseling and decision making.
    Type of Medium: Online Resource
    ISSN: 0029-7844
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2022
    detail.hit.zdb_id: 2012791-1
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  • 9
    In: Obstetrics & Gynecology, Ovid Technologies (Wolters Kluwer Health), Vol. 139, No. 5 ( 2022-05), p. 866-876
    Abstract: To compare health care medical resource utilization in low-risk nulliparous pregnancies according to body mass index (BMI, calculated as weight in kilograms divided by height in meters squared) categories. METHODS: This is a secondary analysis of a multicenter randomized controlled trial of induction of labor between 39 0/7 39 and 4/7 weeks of gestation compared with expectant management in low-risk nulliparous pregnant people , defined as those without standard obstetric indications for delivery at 39 weeks. Body mass index at randomization was categorized into four groups (lower than 25, 25–29, 30–39, and 40 or higher). The primary outcome of this analysis was time spent in the labor and delivery department from admission to delivery. Secondary outcomes included length of stay (LOS) postdelivery, total hospital LOS, and antepartum, intrapartum, and postpartum resource utilization, which were defined a priori. Multivariable generalized linear modeling and logistic regressions were performed, and 99% CIs were calculated. RESULTS: A total of 6,058 pregnant people were included in the analysis; 640 (10.6%) had BMIs of lower than 25, 2,222 (36.7%) had BMIs between 25 and 29, 2,577 (42.5%) had BMIs of 30–39, and 619 (10.2%) had BMIs of 40 or higher. Time spent in the labor and delivery department increased from 15.1±9.2 hours for people with BMIs of lower than 25 to 23.5±13.6 hours for people with BMIs of 40 or higher, and every 5-unit increase in BMI was associated with an average 9.8% increase in time spent in the labor and delivery department (adjusted estimate per 5-unit increase in BMI 1.10, 99% CI 1.08–1.11). Increasing BMI was not associated with an increase in antepartum resource utilization, except for blood tests and urinalysis. However, increasing BMI was associated with higher odds of intrapartum resource utilization, longer total hospital LOS, and postpartum resource utilization. For example, every 5-unit increase in BMI was associated with an increase of 26.1% in the odds of antibiotic administration, 57.6% in placement of intrauterine pressure catheter, 5.1% in total inpatient LOS, 31.0 in postpartum emergency department visit, and 23.9% in postpartum hospital admission. CONCLUSION: Among low-risk nulliparous people, higher BMI was associated with longer time from admission to delivery, total hospital LOS, and more frequent utilization of intrapartum and postpartum resources. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01990612.
    Type of Medium: Online Resource
    ISSN: 0029-7844
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2022
    detail.hit.zdb_id: 2012791-1
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  • 10
    In: Obstetrics & Gynecology, Ovid Technologies (Wolters Kluwer Health), Vol. 142, No. 1 ( 2023-07), p. 117-124
    Abstract: To evaluate the association between maternal and delivery characteristics and self-reported perceived control during childbirth. METHODS: A secondary analysis of a multicenter randomized trial was conducted to compare labor induction at 39 weeks of gestation with expectant management in low-risk nulliparous people. Six to 96 hours after delivery, participants who experienced labor completed the Labor Agentry Scale, a validated self-administered questionnaire to ascertain perceived control during childbirth. Scores range from 29 to 203, with higher scores indicating a sense of greater control. Multivariable linear regression was used to determine which maternal and delivery characteristics were associated with the Labor Agentry Scale score. Eligible characteristics included age, self-reported race and ethnicity, marital status, employment status, type of insurance, previous pregnancy loss before 20 weeks of gestation, body mass index (BMI), smoking, alcohol use, mode of delivery, labor pain (0–10 points), and a composite of perinatal death or severe neonatal complications. Significant variables ( P 〈 .05) were retained in the final multivariable model, and adjusted mean differences (95% CIs) between groups were estimated. RESULTS: Of 6,106 people enrolled in the trial, 6,038 experienced labor, of whom 5,750 (95.2%) completed the Labor Agentry Scale and were included in this analysis. Mean [95% CI] adjusted Labor Agentry Scale scores were significantly lower among those who identified as Asian (−6.4 [−10.5 to −2.3] ) or Hispanic (−3.7 [−5.7 to −1.7]) compared with White, smoked compared with did not smoke (−2.8 [−5.5 to −0.1] ), had BMIs of 35 or higher compared with less than 30 (−2.0 [−3.8 to −0.2]), were unemployed (−3.15 [−4.76 to −1.55] ), did not have private health insurance (−2.61 [−4.47 to −0.76]), underwent operative vaginal (−5.1 [−7.7 to −2.6] ) or cesarean (−14.4 [−16.1 to −12.6]) delivery compared with spontaneous vaginal delivery, and reported greater labor pain score of 8 or higher compared with less than 8 (−11.9 [−13.4 to −10.4] ). Mean [95% CI] adjusted Labor Agentry Scale scores were significantly higher among people who were employed compared with unemployed (3.2 [1.6–4.8] ) and had private compared with nonprivate insurance (2.6 [0.76–4.5]). CONCLUSION: In nulliparous people at low risk, unemployment, lack of private health insurance, Asian race, Hispanic ethnicity, smoking, operative delivery, and more labor pain were associated with lower perceived control during labor. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01990612.
    Type of Medium: Online Resource
    ISSN: 0029-7844
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2023
    detail.hit.zdb_id: 2012791-1
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