Journal article
Prediction of Pregnancy Complications Related to Placental Dysfunction: Protocol for a Prospective Cohort Study (Placental Health Study)
JMIR Research Protocols, Vol.15, pp.1-13
2026
PMCID: PMC13504624
PMID: 42640136
Abstract
Background
Placental dysfunction underlies major obstetric complications, including preeclampsia, fetal growth restriction, preterm birth, and stillbirth. While early identification of pregnancies at high risk of complications enables preventive interventions, current screening methods based on traditional risk factors have limited accuracy.
Objective
This study aims to develop robust prediction models for placental dysfunction–related pregnancy disorders across 3 gestational windows and to determine the optimal delivery time by integrating maternal characteristics, biophysical measurements, and maternal circulating biomarkers.
Methods
The Placental Health Study is a prospective cohort study conducted at the Maternal Fetal Medicine Unit at Gold Coast University Hospital, Australia. Singleton pregnancies are enrolled at 11 to 13 weeks, 26 to 28 weeks, and 35 to 36 weeks of gestation and are followed until delivery. Exclusion criteria are multiple pregnancies, major fetal anomalies, maternal age below 18 years, and inability to provide informed consent. Clinical data, standardized ultrasound and Doppler measurements, hemodynamic parameters, and biospecimens (serum, plasma, whole blood RNA, and urine) are collected at each visit. Three gestational age-specific datasets (11‐13 weeks, 26‐28 weeks, and 35‐36 weeks) will be constructed for model development. Prediction models will be developed using multivariable logistic regression. Competing risks (Fine and Gray) models will be used as sensitivity analyses for outcomes related to gestational age at delivery. Bayesian updating will be applied to refine existing Fetal Medicine Foundation risk estimates using additional biomarkers or variables collected later in pregnancy. Developed models will undergo internal validation via 5-fold cross-validation, with performance assessed through model discrimination, calibration, and comparison against existing approaches. Collected biospecimens will also be analyzed for angiogenic markers and exploratory omics studies.
Results
Recruitment occurred from June 2022 to February 2026, enrolling 1267 participants. As of submission, 1072 (84.6%) participants have completed their pregnancies, 144 (11.4%) participants remain active in follow-up, and 51 (4%) were withdrawn or had missing or duplicated data. Clinical data have undergone preliminary cleaning and descriptive analysis. Biospecimens are being processed for biomarker quantification and exploratory molecular analyses. Two to three publications are anticipated in late 2026 or early 2027.
Conclusions
This cohort establishes a comprehensive database and biospecimen repository to advance prediction of placental dysfunction–related complications. Three-stage recruitment integrated into routine clinical care enhances feasibility and translation potential, enabling dynamic risk assessment and investigation of temporal biomarker changes. Although the single-center design may limit generalizability, warranting future external validation, the interdisciplinary research team brings diverse expertise that strengthens study depth and scope
Details
- Title
- Prediction of Pregnancy Complications Related to Placental Dysfunction: Protocol for a Prospective Cohort Study (Placental Health Study)
- Authors
- Luhao Han - Griffith UniversityOlivia Holland - Griffith UniversityHasini Rathnayake - University of PeradeniyaCristiane de Freitas Paganoti - Gold Coast HospitalConrado Sávio Ragazini - Gold Coast HospitalElsa Suk Fan Chan - Gold Coast HospitalSally Mahler - Gold Coast HospitalCarman Wing Sze Lai - Griffith UniversityDaniel Lorber Rolnik - Monash HealthAnthony Perkins - University of the Sunshine CoastDavid Ellwood - Griffith UniversitySailesh Kumar - The University of QueenslandFabricio Da Silva Costa - Griffith University
- Publication details
- JMIR Research Protocols, Vol.15, pp.1-13
- Publisher
- JMIR Publications, Inc.
- Date published
- 2026
- DOI
- 10.2196/95231
- ISSN
- 1929-0748
- PMID
- 42640136; PMC13504624
- Copyright note
- © Luhao Han, Olivia Holland, Hasini Rathnayake, Cristiane de Freitas Paganoti, Conrado Sávio Ragazini, Elsa Suk Fan Chan, Sally Mahler, Carman Wing Sze Lai, Daniel Lorber Rolnik, Anthony Perkins, David Ellwood, Sailesh Kumar, Fabricio Da Silva Costa. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 25.Aug.2026. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
- Data Availability
- Data collection and analyses for this prospective cohort study are still ongoing. After completion of the primary analyses and related publications, deidentified data will be available from the corresponding author upon reasonable request. All requests will be assessed by the research team in accordance with the existing ethics approval and institutional data governance policies to protect participant confidentiality and comply with ethics requirements.
- Grant note
- Gold Coast Hospital Foundation Collaborative Grant Scheme and the Griffith University Health Group Seed Grant.
- Organisation Unit
- School of Health
- Language
- English
- Record Identifier
- 991262296202621
- Output Type
- Journal article
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