Lactogenesis and breastfeeding after immediate vs delayed birth-hospitalization insertion of etonogestrel contraceptive implant: a noninferiority trial.

BACKGROUND: Initiating a progestin-based contraceptive before the drop in progesterone required to start lactogenesis stage II could theoretically affect lactation. Previous studies have shown that initiating progestin-based contraception in the postnatal period before birth-hospitalization discharge has no detrimental effects on breastfeeding initiation or continuation compared with outpatient interval initiation. However, there are currently no breastfeeding data on the impact of initiating the etonogestrel contraceptive implant in the early postnatal period immediately in the delivery room. OBJECTIVE: This study examined the effect of delivery room vs delayed birth-hospitalization contraceptive etonogestrel implant insertion on breastfeeding outcomes. STUDY DESIGN: This was a noninferiority randomized controlled trial to determine if time to lactogenesis stage II (initiation of copious milk secretion) differs by timing of etonogestrel implant insertion during the birth-hospitalization. We randomly assigned pregnant people to insertion at 0 to 2 hours (delivery room) vs 24 to 48 hours (delayed) postdelivery. Participants intended to breastfeed, desired a contraceptive implant for postpartum contraception, were fluent in English or Spanish, and had no allergy or contraindication to the etonogestrel implant. We collected demographic information and breastfeeding intentions at enrollment. Onset of lactogenesis stage II was assessed daily using a validated tool. The noninferiority margin for the mean difference in time to lactogenesis stage II was defined as 12 hours in a per-protocol analysis. Additional electronic surveys collected data on breastfeeding and contraceptive continuation at 2 and 4 weeks, and 3, 6, and 12 months. RESULTS: We enrolled and randomized 95 participants; 77 participants were included in the modified intention-to-treat analysis (n=38 in the delivery room group and n=39 in the delayed group) after excluding 18 because of withdrawing consent, changing contraceptive or breastfeeding plans, or failing to provide primary outcome data. A total of 69 participants were included in the as-treated analysis (n=35 delivery room, n=34 delayed); 8 participants who received the etonogestrel implant outside the protocol windows were excluded, and 2 participants from the delivery room group received the etonogestrel implant at 24 to 48 hours and were analyzed with the delayed group. Participants were similar between groups in age, gestational age, and previous breastfeeding experience. Delivery room insertion was noninferior to delayed birth-hospitalization insertion in time to lactogenesis stage II (delivery room [mean±standard deviation], 65±25 hours; delayed, 73±61 hours; mean difference, -9 hours; 95% confidence interval, -27 to 10). Onset of lactogenesis stage II by postpartum day 3 was not significantly different between the groups. Lactation failure occurred in 5.5% (n=2) participants in the delayed group. Ongoing breastfeeding rates did not differ between the groups, with decreasing rates of any/exclusive breastfeeding over the first postpartum year. Most people continued to use the implant at 12 months, which did not differ by group. CONCLUSION: Delivery room insertion of the contraceptive etonogestrel implant does not delay the onset of lactogenesis when compared with initiation later in the birth-hospitalization and therefore should be offered routinely as part of person-centered postpartum contraceptive counseling, regardless of breastfeeding intentions.

Management experience of pediatric meningioma in a Mexican reference center.

OBJECTIVE: Determine the histopathological and clinical characteristics of patients diagnosed with meningiomas and to establish the frequency of these tumors in the pediatric population Mexican. Determine the NF1/2 frequency in meningioma pediatric. METHODS: Samples from the histopathology file were reviewed, and from the complete clinical file the following patient data was reviewed: age, gender, diagnosis, diagnosis year, surgical resection, location, tumor size, symptoms, and family background. The frequency of NF1/2 in pediatric meningioma was reviewed in literature. RESULTS: Forty-four de novo cases were collected from pediatric patients; 19 were female patients and 25 males. The most frequent histological subtype was transitional meningioma. Of all the cases, 75% had a supratentorial localization and 20% had an extramedullary intrarachidian localization. Some clinical manifestations included seizures, paresis, headache, and visual disturbances. CONCLUSION: There is a low incidence of meningiomas in the pediatric population, more than 70% are Grade I, and they have supratentorial localization.

The obstetrical research landscape: a cross-sectional analysis of clinical trials from 2007-2020.

Background: Obstetrical complications affect more than a third of women globally, but are underrepresented in clinical research. Little is known about the comprehensive obstetrical clinical trial landscape, how it compares with other fields, or factors associated with the successful completion of obstetrical trials. Objective: This study aimed to characterize obstetrical clinical trials registered on ClinicalTrials.gov with the primary objective of identifying features associated with early discontinuation and results reporting. Study Design: This is a cross-sectional study with descriptive, logistic regression and Cox regression analyses of clinical trials registered on ClinicalTrials.gov. Our primary exposure variables were trial focus (obstetrical or nonobstetrical) and trial funding (industry, United States government, or academic). We conducted additional exploratory analyses of other trial features including design, enrollment, and therapeutic focus. We examined the associations of exposure variables and other trial features with 2 primary outcomes: early discontinuation and results reporting. Results: We downloaded data for all studies (N=332,417) registered on ClinicalTrials.gov from October 1, 2007, to March 9, 2020, from the Aggregate Analysis of ClinicalTrials.gov database. We excluded studies with a noninterventional design (n=63,697) and those registered before October 1, 2007 (n=45,209). A total of 4276 obstetrical trials (1.9%) (ie, interventional studies) and 219,235 nonobstetric trials (98.1%) were compared. Among all trials, 2.8% of academic-funded trials, 1.9% of United States government-funded trials, and 0.4% of industry-funded trials focused on obstetrics. The quantity of obstetrical trials increased over time (10.8% annual growth rate). Compared with nonobstetrical trials, obstetrical trials had a greater risk of early discontinuation (adjusted hazard ratio, 1.40; 95% confidence interval, 1.21-1.62; P<.0001) and similar odds of results reporting (adjusted odds ratio, 0.89; 95% confidence interval, 0.72-1.10; P=.19). Among obstetrical trials funders after controlling for confounding variables, United States government-funded trials were at the lowest risk of early discontinuation (United States government, adjusted hazard ratio, 0.23; 95% confidence interval, 0.07-0.69; P=.009; industry reference; academic, adjusted hazard ratio, 1.04; 95% confidence interval, 0.62-1.74; P=.88). Academic-funded trials had the lowest odds of results reporting after controlling for confounding variables (academic institutions, adjusted odds ratio, 0.39; 95% confidence interval, 0.22-0.68; P=.0009; industry reference; United States government, adjusted odds ratio, 1.06; 95% confidence interval, 0.53-2.09; P=.87). Conclusion: Obstetrical trials represent only 1.9% of all clinical trials in ClinicalTrials.gov and have comparatively poor completion. All stakeholders should commit to increasing the number of obstetrical trials and improving their completion and dissemination to ensure clinical research reflects the obstetrical burden of disease and advances maternal health.

[Prognostic and survival factors among pediatric patients with ependymomas]. / Factores pronósticos y sobrevida de pacientes pediátricos con ependimomas.

BACKGROUND: Ependymomas constitute the third most common intracranial tumors in children. Risk factors include age, location, extent of surgical excision, and radiation therapy. Recently, chromosomal imbalances have been described. OBJECTIVE: Determine global survival of patients with ependymomas according to different prognostic factors. METHODS: We reviewed the medical charts of every pediatric patient with ependymoma from 1996 to 2005. Genomic imbalances were determined using comparative genomic hybridization (CGH). Survival was calculated using the Kaplan and Meier method. We used the Log Rank test for each risk factor. Death risk was calculated by odds ratio (OR). RESULTS: We included 24 patients. Global survival was 58.04%. The presence of chromosomal imbalances, particularly in chromosome 21, significantly affected survival Being under 5 years of age, anaplastic histology, chemotherapy other than ICE (ifosfamida-carboplatin-etoposide) and partial resection increased the risk of death. CONCLUSIONS: Known risk factors were confirmed in our study, including chromosomal imbalances. We describe a new chromosomal imbalance in chromosome 21 among 30% of study participants.

Acceptability of a text message-based fertility awareness application for family planning in Lucknow, India.

OBJECTIVE: To assess user satisfaction and acceptability toward a cell phone-based short message system (SMS) application for fertility awareness. METHODS: Between July 1 and September 30, 2013, the present observational study recruited women of reproductive age who were presenting for family planning services in Lucknow, India, who were not pregnant, agreed to use the application, and understood basic English. The application collected information on an individual's menstrual cycle and, using the calendar days approach, predicted fertility. Based on an algorithm, the application sent a daily SMS text indicating the participant's fertility status. Participants completed an acceptability survey at the end of the 60-day pilot period. RESULTS: There were 21 participants enrolled. All reported that the application was highly acceptable, and found it to be private, secure, and convenient. All participants were interested in receiving future SMS reminders for tracking fertility. Most participants (20 [95%]) reported being likely or very likely to recommend the family planning application to friends. CONCLUSION: The application, with the aims of helping participants to identify their most fertile days once a month during ovulation and make informed decisions regarding fertility and contraception, was highly acceptable and might be useful in low-resource settings worldwide. Larger studies are needed for software optimization and determination of long-term effectiveness.

Factores pronósticos y sobrevida de pacientes pediátricos con ependimomas / Prognostic and survival factors among pediatric patients with ependymomas

Antecedentes: El ependimoma es el tercer tumor intracraneano más frecuente en pediatría. Los factores que influyen en el pronóstico son la localización, la edad del paciente, la resección quirúrgica y el tratamiento con radioterapia. Recientemente se ha descrito la presencia de alteraciones cromosómicas en el tumor como factor de mal pronóstico. El objetivo de esta investigación fue determinar la sobrevida de pacientes pediátricos con ependimoma de acuerdo con los diferentes factores pronósticos. Métodos: Se revisaron los expedientes de pacientes pediátricos con ependimoma de 1996 a 2005. Se determinaron las alteraciones cromosómicas mediante hibridación genómica comparativa. Se calculó la sobrevida de acuerdo con el método Kaplan-Meier y prueba de log rank de acuerdo a cada factor pronóstico. Se calculó el riesgo de morir para cada factor de acuerdo con la razón de momios. Resultados: Se incluyeron 24 pacientes. La sobrevida global fue de 58.04%. La presencia de alteraciones cromosómicas, particularmente en el cromosoma 21, afectó significativamente la sobrevida. La edad menor a cinco años, la histología anaplásica, la quimioterapia diferente a ifosfamida-carboplatino-etopósido y la resección parcial aumentaron el riesgo de morir. Conclusiones: Se confirman los factores descritos anteriormente en la literatura, incluyendo alteraciones cromosómicas. Se describe un nuevo desbalance en el cromosoma 21 en 30% de los pacientes.

BACKGROUND: Ependymomas constitute the third most common intracranial tumors in children. Risk factors include age, location, extent of surgical excision, and radiation therapy. Recently, chromosomal imbalances have been described. OBJECTIVE: Determine global survival of patients with ependymomas according to different prognostic factors. METHODS: We reviewed the medical charts of every pediatric patient with ependymoma from 1996 to 2005. Genomic imbalances were determined using comparative genomic hybridization (CGH). Survival was calculated using the Kaplan and Meier method. We used the Log Rank test for each risk factor. Death risk was calculated by odds ratio (OR). RESULTS: We included 24 patients. Global survival was 58.04%. The presence of chromosomal imbalances, particularly in chromosome 21, significantly affected survival Being under 5 years of age, anaplastic histology, chemotherapy other than ICE (ifosfamida-carboplatin-etoposide) and partial resection increased the risk of death. CONCLUSIONS: Known risk factors were confirmed in our study, including chromosomal imbalances. We describe a new chromosomal imbalance in chromosome 21 among 30% of study participants.