Abstract：
BACKGROUND: 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.
METHODS: 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.
BACKGROUND: 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.
METHODS: 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.
BACKGROUND: 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.
摘要：
背景：卵母细胞捐献（OD）妊娠伴随着高血压并发症的高发生率，对母亲和孩子造成严重后果。最佳护理管理，涉及早期识别，优化合适的治疗方案，并可能最终预防，需求很高。预测OD中高血压并发症的患者特异性危险因素可以为此提供依据。本项目旨在建立首个OD妊娠高血压并发症风险预测模型。
方法：本研究是在生殖中卵母细胞的DONation项目中进行的。对于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,将获得一份分娩后的母体外周血和脐带血样本或儿童的唾液样本，为了确定胎儿-母体人类白细胞抗原错配的数量。收集数据后，将为二元结局高血压并发症\'是\'和\'否\'建立多变量逻辑回归模型.预测模型风险偏差评估工具将被用作指南，以最大程度地降低偏差风险。该研究将按照“个人预后或诊断多变量预测模型的透明报告”指南进行报告。将确定鉴别和校准以评估模型性能。将使用引导方法执行内部验证。外部验证将使用“生殖个体参与者数据中卵母细胞的DONation”数据集进行。
背景：这项研究得到了医学伦理委员会LDD的批准（莱顿，DenHaag,代尔夫特),方案编号P16.048和一般评估注册(ABR)编号NL56308.058.16。进一步的结果将通过同行评审的期刊和国际会议分享。
方法：本研究是在生殖中卵母细胞的DONation项目中进行的。对于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,将获得一份分娩后的母体外周血和脐带血样本或儿童的唾液样本，为了确定胎儿-母体人类白细胞抗原错配的数量。收集数据后，将为二元结局高血压并发症\'是\'和\'否\'建立多变量逻辑回归模型.预测模型风险偏差评估工具将被用作指南，以最大程度地降低偏差风险。该研究将按照“个人预后或诊断多变量预测模型的透明报告”指南进行报告。将确定鉴别和校准以评估模型性能。将使用引导方法执行内部验证。外部验证将使用“生殖个体参与者数据中卵母细胞的DONation”数据集进行。
背景：这项研究得到了医学伦理委员会LDD的批准（莱顿，DenHaag,代尔夫特),方案编号P16.048和一般评估注册(ABR)编号NL56308.058.16。进一步的结果将通过同行评审的期刊和国际会议分享。
