Development of the DONOR prediction model on the risk of hypertensive complications in oocyte donation pregnancy: study protocol for a multicentre cohort study in the Netherlands.

Autor:	Lafeber GCM; Obstetrics & Gynecology, Leiden University Medical Center, Leiden, The Netherlands g.c.m.lafeber@lumc.nl., Van der Endt VHW; Obstetrics & Gynecology, Leiden University Medical Center, Leiden, The Netherlands., Louwers Y; Obstetrics and Gynecology, Erasmus MC, Rotterdam, The Netherlands., le Cessie S; Epidemiology, Leids Universitair Medisch Centrum, Leiden, The Netherlands., van der Hoorn MP; Obstetrics & Gynecology, Leiden University Medical Center, Leiden, The Netherlands., Lashley EELO; Obstetrics & Gynecology, Leiden University Medical Center, Leiden, The Netherlands.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2024 Jul 03; Vol. 14 (7), pp. e079394. Date of Electronic Publication: 2024 Jul 03.
DOI:	10.1136/bmjopen-2023-079394
Abstrakt:	Introduction: 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 and Analysis: 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. Ethics and Dissemination: 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. Competing Interests: Competing interests: EELOL has received the ZonMw Clinical Fellows 2021 Grant, with project code 09032212110062. YL has received honoraria for lectures and presentations by Merck and Ferring. Moreover, YL is supported by Gideon Richter to attend the ORBIS program (a 3-year expert-led program). GCML, VHWVdE, SlC and M-LPvdH have no competing interests. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)
Databáze:	MEDLINE
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