1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [sgoudar@jnmc.edu].
   


6. For how long will this data be available start date provided 01-08-2028 and end date provided 01-07-2033?
   Response - Beginning 3 months and ending 5 years following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

PAPAGAIO: Preterm pre-eclampsiA: PlAcental Growth factor (PIGF) testing for reduction of Adverse Outcomes

Background: It is estimated that preeclampsia causes 30,000 maternal and 500,000 perinatal deaths annually, most of which occur in low- and middle-income countries. Many of these deaths could be preventable with early diagnosis and appropriately timed delivery. Preeclampsia diagnosis can be challenging in high-burden, low-resource settings. Placental growth factor (PlGF) is abnormally low in pre-eclampsia. PlGF outperforms all other preeclampsia diagnostics, reducing time to diagnosis and adverse maternal outcomes in a high-income setting. It has not yet been definitively evaluated in low resource settings, where the greatest health burden lies.

Objectives:

1)            Describe care pathways for preterm pre-eclampsia, identify barriers to, and facilitators of  

PlGF testing in LMICs

2)            Assess clinical and cost effectiveness of PlGF testing in suspected preterm pre-eclampsia

3)            Evaluate clinical and cost effectiveness of planned early delivery in late preterm preeclampsia with diagnosis incorporating PlGF testing

4)            Validate new point of care PlGF test devices

5)            Establish a biobank of samples from women with suspected and confirmed preeclampsia.

6)            Sustainably build local research capacity at individual and institutional levels.

Methods: There are five main workstreams that will be conducted semi-concurrently.

1. Prepare for PAPAGAIO: a six-month mixed-methods observational feasibility study to describe current preeclampsia care, optimise PlGF testing and conduct community engagement.

2. PAPAGAIO-Diagnosis: a randomised controlled trial comparing revealed PlGF to usual care, in women with suspected pre-eclampsia.

3. PAPAGAIO-Delivery: a randomised controlled trial comparing planned delivery with usual care of expectant management, in women with late preterm pre-eclampsia (diagnosis incorporating PlGF testing)

4. PAPAGAIO New Test Validation Study: a validation study of new point of care PlGF testing devices on 1500 samples. The results will be concealed from participants and clinicians and not used to inform clinical care.

5. PAPAGAIO Biobank: Establish a biobank of blood and urine samples from 1500 women suspected and confirmed preeclampsia for the use in future ethically approved research studies.

Update as on 25 April 2026

The trial protocol has been amended, so that we are randomising to the test, rather than after the result of the test. This is a similar design to the PAPAGAIO-diagnosis part of the research programme (ethical approval has been obtained for the amended protocol from the Site EC’s) but allows us to answer the research question with increased numbers. Women are randomised to usual care (control arm, without PlGF testing), or the intervention, which is PlGF testing, with women with confirmed pre-eclampsia (abnormal PlGF) having planned early delivery, and women with normal PlGF (pre-eclampsia ruled out) having expectant management.

This will address the same research question of whether planned early delivery for women with pre-eclampsia incorporating PlGF will reduce maternal and perinatal adverse outcomes.