ResearchPad - 1846 https://www.researchpad.co Default RSS Feed en-us © 2020 Newgen KnowledgeWorks <![CDATA[Live birth after in vitro maturation versus standard in vitro fertilisation for women with polycystic ovary syndrome: protocol for a non-inferiority randomised clinical trial]]> https://www.researchpad.co/article/N24cc594a-433f-4d6c-89ca-9e727a601633 Polycystic ovary syndrome (PCOS) is the first common cause of anovulatory infertility. Currently, in vitro fertilisation (IVF) is recommended when conventional attempts have failed. In vitro maturation (IVM) of human oocytes is an emerging treatment option in infertile women with PCOS. It is a patient-friendly intervention, avoiding the risk of ovarian hyperstimulation syndrome, which is a serious complication of controlled ovarian stimulation in the standard IVF procedure. We plan a randomised controlled trial (RCT) to evaluate whether IVM is non-inferior to the standard IVF for live birth in women with PCOS.Methods and analysisThis is a single-centre, open-label, non-inferiority RCT performed in a large reproductive medicine centre in China. Infertile women with PCOS will be randomised to receive either IVM or standard IVF in a 1:1 treatment ratio after informed consent. IVF procedures used in our study are all standard treatments and other standard-assisted reproductive technologies will be similar between the two groups. The primary outcome is ongoing pregnancy leading to live birth within 6 months of the first oocyte retrieval cycle after randomisation. Pregnancy outcome, maternal safety and obstetric and perinatal complications will be secondary outcomes. The planned sample size is 350 (175 per group).Ethics and disseminationEthical permission was acquired from the Ethics Committee of Peking University Third Hospital. The results will be issued to publications through scientific journals and conference reports.Trial registration numberNCT03463772. ]]> <![CDATA[Prediction of gestational age with symphysis-fundal height and estimated uterine volume in a pregnancy cohort in Sylhet, Bangladesh]]> https://www.researchpad.co/article/N95de8ef4-9ff4-4198-9806-c90d876fde99

Objective

To improve the accuracy of the prediction of gestational age (GA) before birth with the standardised measurement of symphysis-fundal height (SFH), estimation of uterine volume, and statistical modelling including maternal anthropometrics and other factors.

Design

Prospective pregnancy cohort study.

Setting

Rural communities in Sylhet, Bangladesh.

Participants

1516 women with singleton pregnancies with early pregnancy ultrasound dating (<20 weeks); 1486 completed follow-up.

Methods

SFH and abdominal girth were measured at subsequent antenatal care (ANC) visits by community health workers at 24 to 28, 32 to 36, and/or >37 weeks gestation. An estimated uterine volume (EUV) was calculated from these measures. Data on pregnancy characteristics and other maternal anthropometrics were also collected.

Primary outcome measure

GA at subsequent ANC visits, as defined by early ultrasound dating.

Results

1486 (98%) women had at least one subsequent ANC visit, 1102 (74%) women had two subsequent ANC visits, and 748 (50%) had three visits. Using the common clinical practice of approximating the GA (in weeks) with the SFH measurement (cm), SFH systematically underestimated GA in late pregnancy (mean difference −4.4 weeks, 95% limits of agreement −12.5 to 3.7). For the classification of GA <28 weeks, SFH <26 cm had 85% sensitivity and 81% specificity; and for GA <34 weeks, SFH <29 cm had 83% sensitivity and 71% specificity. EUV had similar diagnostic accuracy. Despite rigorous statistical modelling of SFH, accounting for repeated longitudinal measurements and additional predictors, the best model without including a known last menstrual period predicted 95% of pregnancy dates within ±7.4 weeks of early ultrasound dating.

Conclusions

We were unable to predict GA with a high degree of accuracy before birth using maternal anthropometric measures and other available maternal characteristics. Efforts to improve GA dating in low- and middle-income countries before birth should focus on increasing coverage and training of ultrasonography.

Trial registration number

NCT01572532

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<![CDATA[A prospective cohort for the investigation of alteration in temporal transcriptional and microbiome trajectories preceding preterm birth: a study protocol]]> https://www.researchpad.co/article/5c64467dd5eed0c484c2be29

Introduction

Preterm birth (PTB) results from heterogeneous influences and is a major contributor to neonatal mortality and morbidity that continues to have adverse effects on infants beyond the neonatal period. This protocol describes the procedures to determine molecular signatures predictive of PTB through high-frequency sampling during pregnancy, at delivery and the postpartum period.

Methods and analysis

Four hundred first trimester pregnant women from either Myanmar or Thailand of either Karen or Burman ethnicity, with a viable, singleton pregnancy will be enrolled in this non-interventional, prospective pregnancy birth cohort study and will be followed through to the postpartum period. Fortnightly finger prick capillary blood sampling will allow the monitoring of genome-wide transcript abundance in whole blood. Collection of stool samples and vaginal swabs each trimester, at delivery and postpartum will allow monitoring of intestinal and vaginal microbial composition. In a nested case–control analysis, perturbations of transcript abundance in capillary blood as well as longitudinal changes of the gut, vaginal and oral microbiome will be compared between mothers giving birth to preterm and matched cases giving birth to term neonates. Placenta tissue of preterm and term neonates will be used to determine bacterial colonisation as well as for the establishment of coding and non-coding RNA profiles. In addition, RNA profiles of circulating, non-coding RNA in cord blood serum will be compared with those of maternal peripheral blood serum at time of delivery.

Ethics and dissemination

This research protocol that aims to detect perturbations in molecular trajectories preceding adverse pregnancy outcomes was approved by the ethics committee of the Faculty of Tropical Medicine, Mahidol University in Bangkok, Thailand (Ethics Reference: TMEC 15–062), the Oxford Tropical Research Ethics Committee (Ethics Reference: OxTREC: 33–15) and the local Tak Province Community Ethics Advisory Board. The results of this cooperative project will be disseminated in multiple publications staggered over time in international peer-reviewed scientific journals.

Trial registration number

NCT02797327; Pre-results.

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