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STUDY OBJECTIVES: This study aimed to assess the effectiveness of cognitive behavioral therapy for insomnia (CBTI) during the postpartum period as part of a larger randomized controlled trial of CBTI on perinatal insomnia. METHODS: A total of 179 women of 18-30 gestational weeks with insomnia disorder were randomly assigned to CBTI or an active control (CTRL) therapy. Participants were assessed between 18 and 32 weeks of pregnancy at baseline, after the intervention during pregnancy, and at 8, 18, and 30 weeks postpartum. The primary outcomes were Insomnia Severity Index (ISI) scores and total awake time, defined as minutes awake during the sleep opportunity period, assessed with actigraphy and sleep diaries. Included in the analyses were women who provided data for at least 1 of 3 postpartum assessments (68 in CBTI; 61 in CTRL). RESULTS: Piecewise mixed-effects models revealed a main effect reflecting reduction in ISI scores from 8-18 weeks postpartum (P = .036) and a nonsignificant increase from 18-30 weeks; significant effects for group allocation were present only in week 30 (P = .042). CTRL participants reported significantly longer time awake, excluding time spent caring for the infant, at each postpartum assessment; time awake at night caring for the infant did not differ between groups. There was no significant group difference in the postpartum trajectory of actigraphy-measured total awake time, the two diary measures of time awake (P values > .05). CBTI participants with at least 50% reduction in ISI during pregnancy had consistently stable ISI scores (mean < 6) during the postpartum period; those in the CTRL group had variable ISI scores over time with large individual differences. CONCLUSIONS: For women with insomnia disorder during pregnancy, CBTI initiated during pregnancy conferred postpartum benefits in terms of wakefulness after sleep onset (excluding time spent caring for the infant) and insomnia severity, though the latter emerged only later in the postpartum period. These findings underscore the importance of treating insomnia during pregnancy, a conclusion that is further supported by our finding that pregnant women who responded to insomnia treatment during pregnancy experienced better sleep in the postpartum period. CLINICAL TRIAL REGISTRATION: Registry: Clinicaltrials.gov; Name: Treatment for Insomnia During Pregnancy; URL: https://www.clinicaltrials.gov/ct2/show/NCT01846585; Identifier: NCT01846585. CITATION: Manber R, Bei B, Suh S, et al. Randomized controlled trial of cognitive behavioral therapy for perinatal insomnia: postpartum outcomes. J Clin Sleep Med. 2023;19(8):1411-1419.
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Terapia Cognitivo-Conductual , Trastornos del Inicio y del Mantenimiento del Sueño , Femenino , Humanos , Embarazo , Masculino , Trastornos del Inicio y del Mantenimiento del Sueño/terapia , Resultado del Tratamiento , Sueño , Periodo PospartoRESUMEN
OBJECTIVE: To evaluate the effectiveness of cognitive behavioral therapy for insomnia during pregnancy. METHODS: Randomized, unmasked, 3-site controlled trial. Participants were randomly allocated to cognitive behavioral therapy for insomnia (a first-line, empirically supported psychosocial intervention that addresses sleep-related behaviors and cognitions) or a control intervention consisting of imagery exercises that paired patient-identified distressing nighttime experiences with patient-identified neutral images. Participants were eligible if they met diagnostic criteria for insomnia disorder and were between 18 and 32 weeks of gestation. Patients were ineligible if they met diagnostic criteria for major psychiatric disorders, including depression, or were receiving nonstudy treatments that could affect sleep (or both). The primary outcome was the Insomnia Severity Index score, a validated brief questionnaire, with scores between 14 and 21 representing clinically meaningful insomnia of moderate severity, scores higher than 21 representing severe insomnia, and scores less than 8 representing no insomnia. Secondary outcomes included remission of insomnia (Insomnia Severity Index score less than 8), objectively measured and self-reported time awake (ie, total wake time), and the Edinburgh Postnatal Depression Scale score. All outcomes were measured weekly. Analysis included 48 participants who did not complete treatment. We estimated that 184 women would be required to have 80% power, with a two-tailed test, to detect a moderate Cohen's d effect size (.5) with α=.05. RESULTS: Between May 2013 and April 2017, 194 pregnant women were randomized and 149 completed treatment; 179 with available baseline data (92%) were ultimately analyzed, 89 in the cognitive therapy group and 90 in the control group. Women assigned to cognitive behavioral therapy for insomnia experienced significantly greater reductions in insomnia severity (scores decreased from 15.4±4.3 to 8.0±5.2 in the cognitive behavioral therapy group vs from 15.9±4.4 to 11.2±4.9 in the control therapy group [P<.001, d=0.5]). Remission of insomnia (to an Insomnia Severity Index score less than 8) disorder was attained by 64% of women in the cognitive behavioral therapy for insomnia group vs 52% in the control group. Women receiving cognitive behavioral therapy for insomnia experienced faster remission of insomnia disorder, with a median of 31 days vs 48 days in the control therapy (P<.001). Cognitive behavioral therapy for insomnia led to significantly greater reduction in self-reported but not objective total wake time and a small but significantly greater decline in Edinburgh Postnatal Depression Scale scores vs the control group. CONCLUSION: Cognitive behavioral therapy for insomnia is an effective nonpharmacologic treatment for insomnia during pregnancy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01846585.
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Terapia Cognitivo-Conductual/métodos , Complicaciones del Embarazo/terapia , Trastornos del Inicio y del Mantenimiento del Sueño/terapia , Adulto , California , Femenino , Edad Gestacional , Humanos , Evaluación del Resultado de la Atención al Paciente , Embarazo , Atención Prenatal , Inducción de Remisión , Índice de Severidad de la Enfermedad , Encuestas y CuestionariosRESUMEN
OBJECTIVE: The objective of this study was to evaluate whether weekly administration of 17 α-hydroxyprogesterone caproate (17-OHPC) increases the number of women who achieve 34 weeks of gestation after preterm premature rupture of membranes (PPROM). STUDY DESIGN: We conducted a multicenter double-blind, randomized controlled trial of 17-OHPC versus placebo among women with PPROM. Women with singleton pregnancy, clinically confirmed PPROM, and without evidence of active infection or major fetal malformation between 240/7 and 320/7 weeks of pregnancy were offered enrollment. Women received weekly injections of 17-OHPC versus placebo until 340/7 weeks of gestation or delivery. The remainder of care was per hospital protocol. The primary outcome was achievement of 34 weeks of gestation. Secondary outcomes included length of latency and maternal and fetal outcomes. RESULTS: In this study, 21 women were enrolled. Eleven women received placebo and 10 received 17-OHPC. The study was closed prematurely secondary to poor enrollment. None of the women remained pregnant until 34 weeks of gestation. The median latency periods were 8 and 14.5 days for the placebo and 17-OHPC groups, respectively (p = 0.14). There were no differences in maternal or neonatal outcomes. CONCLUSION: We did not identify any benefit from administration of 17-OHPC in pregnancies complicated by PPROM.
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Caproato de 17 alfa-Hidroxiprogesterona/administración & dosificación , Rotura Prematura de Membranas Fetales/tratamiento farmacológico , Progestinas/administración & dosificación , Adulto , California , Método Doble Ciego , Femenino , Edad Gestacional , Humanos , Recién Nacido , Embarazo , Resultado del Embarazo , Nacimiento Prematuro , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVE: To examine the association between race/ethnicity, perineal length and the risk of perineal laceration. METHODS: This is a prospective cohort study of a diverse group of women with singleton gestations in the third trimester of pregnancy. Perineal length was measured and mean values calculated for several racial/ethnic groups. Chi-squared analyses were used to examine rates of severe perineal laceration (third or fourth degree laceration) by race/ethnicity among women considered to have a short perineal length. Further, subgroup analyses were performed comparing nulliparas to multiparas. RESULTS: Among 344 study participants, there was no statistically significant difference in mean perineal length by race/ethnicity (White 4.0 ± 1.1 cm, African-American 3.7 ± 1.0 cm, Latina 4.1 ± 1.1 cm, Asian 3.8 ± 1.0 cm, and other/unknown 4.0 ± 0.9 cm). Considering parity, more multiparous Asian and African-American women had a short perineal length (20.7 and 23.5%, respectively, p = 0.05). Finally, the rate of severe perineal lacerations in our cohort was 2.6% overall, but was 8.2% among Asian women (p = 0.04). CONCLUSIONS: We did not find a relationship between short perineal length and risk of severe perineal laceration with vaginal delivery, or a difference in mean perineal length by maternal race/ethnicity. However, we did find that women of different racial/ethnic groups have varying rates of severe perineal laceration, with Asian women comprising the highest proportion.
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Parto Obstétrico/efectos adversos , Laceraciones/etnología , Complicaciones del Trabajo de Parto/etnología , Perineo/lesiones , Adulto , Etnicidad , Femenino , Humanos , Paridad , Embarazo , Tercer Trimestre del Embarazo , Estudios ProspectivosRESUMEN
IMPORTANCE: Prenatal genetic testing guidelines recommend providing patients with detailed information to allow informed, preference-based screening and diagnostic testing decisions. The effect of implementing these guidelines is not well understood. OBJECTIVE: To analyze the effect of a decision-support guide and elimination of financial barriers to testing on use of prenatal genetic testing and decision making among pregnant women of varying literacy and numeracy levels. DESIGN, SETTING, AND PARTICIPANTS: Randomized trial conducted from 2010-2013 at prenatal clinics at 3 county hospitals, 1 community clinic, 1 academic center, and 3 medical centers of an integrated health care delivery system in the San Francisco Bay area. Participants were English- or Spanish-speaking women who had not yet undergone screening or diagnostic testing and remained pregnant at 11 weeks' gestation (n = 710). INTERVENTIONS: A computerized, interactive decision-support guide and access to prenatal testing with no out-of-pocket expense (n = 357) or usual care as per current guidelines (n = 353). MAIN OUTCOMES AND MEASURES: The primary outcome was invasive diagnostic test use, obtained via medical record review. Secondary outcomes included testing strategy undergone, and knowledge about testing, risk comprehension, and decisional conflict and regret at 24 to 36 weeks' gestation. RESULTS: Women randomized to the intervention group, compared with those randomized to the control group, were less likely to have invasive diagnostic testing (5.9% vs 12.3%; odds ratio [OR], 0.45 [95% CI, 0.25-0.80]) and more likely to forgo testing altogether (25.6% vs 20.4%; OR, 3.30 [95% CI, 1.43-7.64], reference group screening followed by invasive testing). Women randomized to the intervention group also had higher knowledge scores (9.4 vs 8.6 on a 15-point scale; mean group difference, 0.82 [95% CI, 0.34-1.31]) and were more likely to correctly estimate the amniocentesis-related miscarriage risk (73.8% vs 59.0%; OR, 1.95 [95% CI, 1.39-2.75]) and their estimated age-adjusted chance of carrying a fetus with trisomy 21 (58.7% vs 46.1%; OR, 1.66 [95% CI, 1.22-2.28]). Significant differences did not emerge in decisional conflict or regret. CONCLUSIONS AND RELEVANCE: Full implementation of prenatal testing guidelines using a computerized, interactive decision-support guide in the absence of financial barriers to testing resulted in less test use and more informed choices. If validated in additional populations, this approach may result in more informed and preference-based prenatal testing decision making and fewer women undergoing testing. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00505596.
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Técnicas de Apoyo para la Decisión , Pruebas Genéticas , Adhesión a Directriz , Participación del Paciente , Diagnóstico Prenatal , Adulto , Femenino , Pruebas Genéticas/economía , Pruebas Genéticas/estadística & datos numéricos , Alfabetización en Salud , Humanos , Guías de Práctica Clínica como Asunto , Embarazo , Diagnóstico Prenatal/economía , Diagnóstico Prenatal/estadística & datos numéricos , RiesgoRESUMEN
Postmenopausal women with higher circulating estrogen levels are at increased risk of developing breast and endometrial carcinomas. In the endometrium, excess estrogen relative to progesterone produces a net proliferative stimulus, which may result in endometrial thickening. Therefore, the hypothesis that endometrial thickness is a biological marker of excess estrogen stimulation that is associated with risk of breast and endometrial carcinomas was tested. Endometrial thickness was measured in 1,272 postmenopausal women, aged 55-74 years, who underwent transvaginal ultrasound (TVU) screening as part of the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial. Serial endometrial thickness measurements were available for a subset of women at 1 year (n = 1,018), 2 years (n = 869) and 3 years (n = 641) after baseline. The associations between endometrial thickness and breast (n = 91) and endometrial (n = 14) carcinoma were evaluated by estimating relative risks (RRs) and 95% confidence intervals (CIs) using Cox proportional hazards regression with age as the time metric. Models incorporating baseline endometrial thickness and as a time-varying covariate using all measurements were examined. Median follow-up among study participants was 12.5 years (range: 0.3-13.8 years). Compared to baseline endometrial thickness of 1.0-2.99 mm, women with baseline endometrial thickness greater than or equal to 5.0 mm had an increased risk of breast (RR = 2.00, 95% CI = 1.15-3.48) and endometrial (RR = 5.02, 95% CI = 0.96-26.36) carcinomas in models adjusted for menopausal hormone use and BMI. These data suggest that increased endometrial thickness as assessed by TVU was associated with increased risk of breast and endometrial carcinomas.
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Neoplasias de la Mama/etiología , Neoplasias Endometriales/etiología , Endometrio/patología , Anciano , Neoplasias de la Mama/patología , Ensayos Clínicos como Asunto , Neoplasias Endometriales/patología , Femenino , Estudios de Seguimiento , Humanos , Persona de Mediana Edad , Estadificación de Neoplasias , Pronóstico , Estudios Prospectivos , Factores de Riesgo , Tasa de SupervivenciaRESUMEN
OBJECTIVE: To determine whether the change in human chorionic gonadotropin after manual vacuum aspiration is predictive of an early abnormal intrauterine pregnancy in women with pregnancy of unknown location. STUDY DESIGN: This is a prospective cohort study of 23 clinically stable patients with an early abnormal pregnancy who had abnormally rising human chorionic gonadotropins and absence of sonographic evidence of an intrauterine pregnancy or ectopic pregnancy. The change in human chorionic gonadotropin within 24 hours after manual vacuum aspiration was compared with the pathologic diagnosis and the ultimate clinical diagnosis. RESULTS: Ten patients had > or = 50% decrease (mean, 74%; range, 58-80%) in human chorionic gonadotropin after manual vacuum aspiration with confirmed chorionic villi on pathology results. Two patients had a > 50% drop in human chorionic gonadotropin but absence of chorionic villi, clinically consistent with complete spontaneous abortion. The remaining 10 patients who had either rising or < 50% decrease in human chorionic gonadotropin post manual vacuum aspiration all had no chorionic villi on pathology results. The sensitivity, specificity, positive predictive value, and negative predictive value of a > or = 50% decrease in human chorionic gonadotropin after manual vacuum aspiration in predicting an abnormal intrauterine pregnancy were 92% (95% confidence interval [CI], 0.62-0.99), 100% (95% CI, 0.62-1.0), 100% (95% CI, 0.70-1.0), and 90% (95% CI, 0.54-0.99), respectively. CONCLUSION: A > or = 50% decrease in human chorionic gonadotropin within 24 hours after manual vacuum aspiration is predictive of an abnormal intrauterine pregnancy, thereby excluding an ectopic pregnancy and expediting the management of women with pregnancy of unknown location.
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Aborto Espontáneo/metabolismo , Gonadotropina Coriónica/metabolismo , Embarazo Ectópico/metabolismo , Legrado por Aspiración , Aborto Espontáneo/cirugía , Adulto , Biomarcadores/metabolismo , Femenino , Humanos , Valor Predictivo de las Pruebas , Embarazo , Embarazo Ectópico/cirugía , Estudios Prospectivos , Sensibilidad y Especificidad , Adulto JovenRESUMEN
OBJECTIVE: The objective of this study was to evaluate the effectiveness and degree of toxicity of paclitaxel and carboplatin (PC) combination chemotherapy in patients with recurrent or persistent cervical carcinoma. METHODS: Fifteen patients who received PC chemotherapy for recurrent or persistent carcinoma of the cervix at the Magee-Womens Hospital from 1994-1998 were studied retrospectively. Demographic data, pathology, radiation treatment response, site of recurrence, chemotherapy response, survival rates, and toxicities were reviewed. Months of survival were calculated by the method of Kaplan-Meier from the date after initiation of chemotherapy to death or the last date of follow-up. RESULTS: Fifteen patients received PC for recurrence or persistence of disease with a median of six courses of PC (range, four to 26). Fourteen patients (93.3%) had received prior radiation, and one patient had received surgery as the primary therapy. Four (26.7%) of 15 patients had complete response and five (33.3%) had partial response for an overall clinical response rate of 60%. The median survival of all 15 patients treated with PC was 17 months (range, four to 39). Four patients demonstrated progression of disease while two patients had stable disease. Grade 3 or 4 neutropenia occurred in four patients (26.7%) while one patient (6.7%) suffered from sepsis. Three patients (20%) suffered from Grade 2 anemia and four patients (26.7%) patients developed Grade 2 or Grade 3 neuropathy. There was no incidence of nephrotoxicity. CONCLUSIONS: Paclitaxel/carboplatin chemotherapy appears to have promising activity in recurrent or persistent carcinoma of the cervix with an acceptable toxicity profile. Due to patient convenience and tolerance, consideration should be given to carboplatin as an alternative regimen to cisplatin in combination with paclitaxel.
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Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Carcinoma de Células Escamosas/tratamiento farmacológico , Terapia Recuperativa , Neoplasias del Cuello Uterino/tratamiento farmacológico , Adenocarcinoma/tratamiento farmacológico , Adenocarcinoma/patología , Adulto , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Carboplatino/administración & dosificación , Carboplatino/efectos adversos , Carcinoma Adenoescamoso/tratamiento farmacológico , Carcinoma Adenoescamoso/patología , Carcinoma de Células Escamosas/patología , Terapia Combinada , Evaluación de Medicamentos , Femenino , Estudios de Seguimiento , Humanos , Tablas de Vida , Persona de Mediana Edad , Recurrencia Local de Neoplasia , Neutropenia/inducido químicamente , Paclitaxel/administración & dosificación , Paclitaxel/efectos adversos , Enfermedades del Sistema Nervioso Periférico/inducido químicamente , Estudios Retrospectivos , Tasa de Supervivencia , Resultado del Tratamiento , Neoplasias del Cuello Uterino/patologíaRESUMEN
OBJECTIVE: In clinical settings, transvaginal ultrasound has been used to evaluate abnormal vaginal bleeding. Because the endometrium responds to estrogens, endometrial thickness may constitute a biomarker of estrogen status in postmenopausal women. This study aimed to validate the transvaginal ultrasonographic measurement of endometrial thickness as an estrogen biomarker in asymptomatic, postmenopausal women by demonstrating an association between endometrial thickness and risk factors known to be associated with estrogen exposure. METHOD: Endometrial thickness was measured in 1,271 women ages 55 to 74 years who underwent transvaginal ultrasound screening as part of the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial. A questionnaire, completed before screening, provided risk factor information, including reproductive and hormone use histories. RESULTS: Endometrial thickness measurements ranged from 1 to 32 mm (median 3.0 mm). The frequencies of thicker endometrium (> or =3.0 mm), according to body mass index (BMI) quartile, were 55.2%, 66.1%, 69.7%, and 76.7% (P < 0.0001). The frequencies of thicker endometrium were 57.8%, 58.3%, and 82.6% among never users, ex-users, and current users of hormone replacement therapy (HRT), respectively (P < 0.0001). Other factors associated with thicker endometrium included age, marital status, history of uterine fibroids, years since menopause, and history of hypertension. Statistically significant associations were not seen in analyses limited to current HRT users (n = 461). In multiple variable analysis (R2 = 0.08), current HRT use (P < 0.0001) and higher BMI (P < 0.0001) were independently associated with thicker endometrium. CONCLUSION: In postmenopausal women, factors reflecting exogenous (current HRT use) and endogenous (BMI) estrogen exposure were associated with increased endometrial thickness as measured during screening transvaginal ultrasound. Practical limitations related to screening transvaginal ultrasound include measurement variability, lack of information regarding type or dose of HRT, and problems of differentiating true endometrial thickening from unrecognized endometrial polyps or fluid accumulations. Constrained by these limitations, these results partially validate a transvaginal ultrasound measurement of endometrial thickness as a potential biomarker related to estrogen status.
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Endometrio/efectos de los fármacos , Endosonografía , Terapia de Reemplazo de Estrógeno , Anciano , Biomarcadores , Índice de Masa Corporal , Diagnóstico Precoz , Neoplasias Endometriales/diagnóstico por imagen , Endometrio/diagnóstico por imagen , Femenino , Humanos , Persona de Mediana Edad , Tamizaje Multifásico , Valores de Referencia , Medición de RiesgoRESUMEN
OBJECTIVE: Hormone replacement therapy (HRT) has been inconsistently linked to ovarian cancer. Estrogen formulations in HRT vary in their effects on estrogen-sensitive target tissues, such as the ovary. The aim of the study is to evaluate the impact of various HRT formulations and their characteristics of use on the risk of epithelial ovarian carcinoma (EOC). METHODS: We assessed the association between the use of HRT and the risk of invasive EOC in women participating in a population-based, case-control study conducted in the Delaware Valley from 1994 to 1998. Cases aged 45 or above at diagnosis (n = 484) were compared to community controls (n = 926) frequency matched by age and area of residence. Information on HRT formulation, timing, and duration were obtained by in-person interview by trained interviewers. HRT formulations were classified as opposed (estrogen + progestin) or unopposed (estrogen alone). They were further categorized according to the estrogen component as either conjugated equine estrogen (CEE), the most common formulation, or non-CEE. Multivariate unconditional logistic regression analyses were used to adjust for age at diagnosis, number of live births, use of oral contraceptives, family history of ovarian carcinoma, and history of tubal ligation. RESULTS: Overall, no association was found between any use of HRT and EOC. Although use of unopposed non-CEE was associated with a significant decrease in risk among hysterectomized women (OR = 0.17, 95% CI = 0.04,0.82), this was not true for women with an intact uterus (OR = 1.14, 95% CI = 0.44,2.98; P for interaction = 0.049). No significant differences in EOC risk were observed for other HRT formulations. CONCLUSIONS: Our results did not suggest any consistent pattern of altered risk for EOC and the overall use of HRT by specific formulations of HRT.