Obstetrics & Gynecology, Leiden University Medical Center, Leiden, The Netherlands
Obstetrics & Gynecology, Leiden University Medical Center, Leiden, The Netherlands.
BMJ Open. 2024 Jul 3;14(7):e079394. doi: 10.1136/bmjopen-2023-079394.
Oocyte donation (OD) pregnancy is accompanied by a high incidence of hypertensive complications, with serious consequences for mother and child. Optimal care management, involving early recognition, optimisation of suitable treatment options and possibly eventually also prevention, is in high demand. Prediction of patient-specific risk factors for hypertensive complications in OD can provide the basis for this. The current project aims to establish the first prediction model on the risk of hypertensive complications in OD pregnancy.
The present study is conducted within the DONation of Oocytes in Reproduction project. For this multicentre cohort study, at least 541 OD pregnancies will be recruited. Baseline characteristics and obstetric data will be collected. Additionally, one sample of maternal peripheral blood and umbilical cord blood after delivery or a saliva sample from the child will be obtained, in order to determine the number of fetal-maternal human leucocyte antigen mismatches. Following data collection, a multivariate logistic regression model will be developed for the binary outcome hypertensive complication 'yes' and 'no'. The Prediction model Risk Of Bias ASsessment Tool will be used as guide to minimise the risk of bias. The study will be reported in line with the 'Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis' guideline. Discrimination and calibration will be determined to assess model performance. Internal validation will be performed using the bootstrapping method. External validation will be performed with the 'DONation of Oocytes in Reproduction individual participant data' dataset.
This study is approved by the Medical Ethics Committee LDD (Leiden, Den Haag, Delft), with protocol number P16.048 and general assessment registration (ABR) number NL56308.058.16. Further results will be shared through peer-reviewed journals and international conferences.
卵子捐赠（OD）妊娠伴随着高血压并发症的高发率，对母婴都有严重的后果。对最佳护理管理的需求很高，包括早期识别、优化合适的治疗方案，甚至可能最终预防。预测 OD 妊娠中高血压并发症的患者特异性风险因素可为这一管理提供基础。本项目旨在建立首个关于 OD 妊娠中高血压并发症风险的预测模型。
本研究在 DONation of Oocytes in Reproduction 项目中进行。为了进行这项多中心队列研究，将招募至少 541 例 OD 妊娠。将收集基线特征和产科数据。此外，在产后将采集一份母亲外周血和脐带血样本或孩子的唾液样本，以确定胎儿-母亲人类白细胞抗原错配的数量。在数据收集后，将为二项结局“高血压并发症‘是’和‘否’”建立多元逻辑回归模型。将使用 Prediction model Risk Of Bias ASsessment Tool 作为指导，以尽量降低偏倚风险。本研究将按照“用于个体预后或诊断的多变量预测模型的透明报告”指南进行报告。将通过区分和校准来评估模型性能。内部验证将使用 bootstrap 方法进行。外部验证将使用“DONation of Oocytes in Reproduction 个体参与者数据”数据集进行。
该研究已获得莱顿大学医学伦理委员会 LDD（莱顿、海牙、代尔夫特）的批准，其协议编号为 P16.048，一般评估注册（ABR）编号为 NL56308.058.16。进一步的结果将通过同行评议的期刊和国际会议进行分享。
