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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Mar 19, 2026
Open Peer Review Period: Mar 19, 2026 - May 14, 2026
Date Accepted: Jun 18, 2026
(closed for review but you can still tweet)

The final, peer-reviewed published version of this preprint can be found here:

Prediction of Pregnancy Complications Related to Placental Dysfunction: Protocol for a Prospective Cohort Study (Placental Health Study)

Han L, Holland O, Rathnayake H, de Freitas Paganoti C, Ragazini CS, Chan ESF, Mahler S, Lai CWS, Rolnik DL, Perkins A, Ellwood D, Kumar S, Da Silva Costa F

Prediction of Pregnancy Complications Related to Placental Dysfunction: Protocol for a Prospective Cohort Study (Placental Health Study)

JMIR Res Protoc 2026;15:e95231

DOI: 10.2196/95231

PMID: 42640136

Placental Health Study: Prediction of Pregnancy Complications Related to Placental Dysfunction: A Prospective Cohort Study Protocol

  • 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

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 project aims to develop robust prediction models for placental dysfunction-related pregnancy disorders and to determine the optimal delivery time by integrating maternal characteristics, biophysical measurements, and maternal circulating biomarkers.

Methods:

The Placental Health Study (PHS) is a prospective cohort study conducted at the Maternal Fetal Medicine (MFM) Unit at Gold Coast University Hospital (GCUH) in Queensland, Australia. Participants with singleton pregnancies enroll at one of three time points: 11–13 weeks, 26–28 weeks, and 35–36 weeks of gestation. Eligible participants who provide written informed consent are included and will also be invited to continue their participation through subsequent antenatal visits until delivery. Exclusion criteria are multiple pregnancies, major fetal anomalies, maternal age below 18 years, and inability to provide informed consent. Baseline and clinical data, including maternal demographics, obstetric and medical history, and current pregnancy records, will be collected. Each visit includes measuring maternal blood pressure and performing obstetric ultrasound with Doppler ultrasound to assess maternal, placental, and fetal indices and fetal biometry. Biological samples, including maternal serum, plasma, whole blood for RNA extraction, and urine, will be collected and processed for long-term storage at –80 ℃ for biomarker studies. Ethics approval has been granted by the Gold Coast Hospital and Health Service Human Research Ethics Committee (HREC/2022/QGC/84257) and Griffith University Human Research Ethics Committee (GU Ref No.2022/254).

Results:

Recruitment commenced in June 2022 and closed February 2026, with 1,267 participants enrolled, made up of 1,072 participants (84.6%) with a completed pregnancy and 144 participants (11.4%) still to complete their pregnancy, and the remaining 51 (4.0%) withdrawn or with missing/duplicated data. Clinical data have undergone preliminary cleaning and descriptive analysis, while biological samples are being processed for biomarker quantification and exploratory molecular analyses. Two to three publications are anticipated in late 2026 or early 2027, with ongoing analyses focused on biomarker discovery and integration with clinical and ultrasound parameters for prediction model development.

Conclusions:

This cohort establishes a comprehensive database and biospecimen repository, collecting high-quality data and biological samples to advance research in predicting placental dysfunction-related pregnancy complications. Recruitment across three pregnancy stages integrates with routine clinical care, enhancing the feasibility and translation potential, while enabling the investigation of pregnancy progression and associated temporal changes. Although the single-center design may limit the sample size and generalizability of the findings to other settings and populations, the interdisciplinary research team brings diverse expertise that strengthens study depth and scope.


 Citation

Please cite as:

Han L, Holland O, Rathnayake H, de Freitas Paganoti C, Ragazini CS, Chan ESF, Mahler S, Lai CWS, Rolnik DL, Perkins A, Ellwood D, Kumar S, Da Silva Costa F

Prediction of Pregnancy Complications Related to Placental Dysfunction: Protocol for a Prospective Cohort Study (Placental Health Study)

JMIR Res Protoc 2026;15:e95231

DOI: 10.2196/95231

PMID: 42640136

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