Planned early delivery for pregnant women with late preterm pre-eclampsia using placental growth factor testing, compared with usual care, in low- and middle-income countries

ISRCTN	ISRCTN71694447
DOI	https://doi.org/10.1186/ISRCTN71694447
National Institute for Health and Care Research (NIHR)	156828
Sponsor	King's College London
Funder	National Institute for Health and Care Research

Submission date: 05/02/2026
Registration date: 18/02/2026
Last edited: 13/02/2026

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Plain English summary of protocol not provided at time of registration

Contact information

Prof Andrew Shennan
Principal investigator

King's College
London
SE1 8WA
United Kingdom

Phone	+44 02071883634
Email	andrew.shennan@kcl.ac.uk

Prof Leandro de Oliveira
Principal investigator

São Paulo State University
San Paulo
-
Brazil

Email	leandro.gustavo@unesp.br

Ms Alice Hurrell
Public, Scientific

King's College
London
SE1 8WA
United Kingdom

Phone	+44 02071883634
Email	PAPAGAIO@kcl.ac.uk

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Open (masking not used)
Control	Active
Assignment	Parallel
Purpose	Diagnostic, Prevention
Participant information sheet	48989_PIS Delivery PIL_V4_28Jan2026.pdf
Scientific title	Placental growth factor testing and planned early delivery for late preterm pre-eclampsia, compared to usual care in low- and middle-income countries (PAPAGAIO-Delivery): an individualised randomised controlled trial
Study acronym	PAPAGAIO-Delivery
Study objectives
Ethics approval(s)	Approved 21/01/2026, King's College London (3rd Floor, 5-11 Lavington Street, London, SE1 0NZ, United Kingdom; +44 020 7848 8888; rec@kcl.ac.uk), ref: HR-25/26-46663
Health condition(s) or problem(s) studied	Pregnancy complicated by late preterm pre-eclampsia
Intervention	This is an international, multi-centre, parallel-group, individually randomised controlled trial conducted in hospitals in Sierra Leone, Zambia, India, and Brazil. Pregnant women presenting with hypertension between 34+0 and 36+6 weeks of gestation will be screened for eligibility. Interventions Group The intervention is Placental growth factor (PlGF) testing, plus planned early delivery for women with an abnormal PlGF concentration (less than 100 pg/ml) or expectant management for women with a normal PlGF concentration (above 100 pg/ml). Planned delivery to be undertaken as soon as it is safe and feasible. The target will be to commence delivery within 48 hours from randomisation. The use of antenatal corticosteroids for fetal lung maturity will be at the discretion of the clinician in accordance with local guidelines. Delivery will be through induction of labour according to the local protocol (typically administration of misoprostol) or via caesarean section for women in whom an elective procedure was planned; caesarean section will be an option where indicated. Interventions – Control Group Participants allocated to the control group will receive usual care in accordance with local and international clinical guidelines for the management of late preterm pre-eclampsia (34+0 to 36+6 weeks’ gestation). This includes routine maternal and fetal monitoring, antihypertensive and anticonvulsant treatment where indicated, and timing of delivery based on standard clinical assessment and existing practice. Delivery is typically recommended at 37 weeks’ gestation unless earlier delivery is clinically indicated due to maternal or fetal deterioration. PlGF testing will not be used to guide management decisions in the usual care group. Randomisation Method Randomisation will be conducted using a secure web-based randomisation system hosted by OMDA (previously MedSciNet), which will manage allocation and hold the allocation code.
Intervention type	Device
Phase	Phase III
Drug / device / biological / vaccine name(s)	Placental growth factor testing
Primary outcome measure(s)	Maternal severe adverse outcome composite, defined with standardised clinical criteria including severe pre-eclampsia complications and severe hypertension >160 mmHg, from randomisation until primary hospital discharge of the mother, measured using data collected from clinical and hospital record documentation at one time point Perinatal death from birth until primary hospital discharge of the baby measured using data collected from clinical and hospital record documentation of stillbirth or early neonatal death within seven days of life at one time point
Key secondary outcome measure(s)
Completion date	30/06/2027

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	15 Years
Upper age limit	60 Years
Sex	Female
Target sample size at registration	1254
Key inclusion criteria	1. Hypertension 2. 34+0-36+6 3. Singleton pregnancy 4. Viable fetus at the time of randomisation 5. Able to give informed consent
Key exclusion criteria	1. In labour 2. Decision to deliver within 48 hours already made (including due to indication for immediate delivery, as defined by WHO guidelines and standard local practice)
Date of first enrolment	23/02/2026
Date of final enrolment	30/04/2027

Locations

Countries of recruitment

Brazil
India
Sierra Leone
Zambia

Study participating centres

University Teaching Hospital

Zambia

Kabwe Central Hospital

India

Kitwe Teaching Hospital

Zambia

Ndola Teaching Hospital

Zambia

Botucatu Medical School, Sao Paulo State University

Brazil

Campinas State University

Brazil

Sao Paulo State University

Brazil

Federal University of Minas Gerais

Brazil

Brasilia University

Brazil

Federal University of Penanbuco

Brazil

Princess Christian Maternity Hospital, Freetown

Sierra Leone

Aberdeen Women’s Centre

Sierra Leone

KIMS Hubli

India

BLDE Sri B M Patil Medical College, Vijayapura

India

PGIMER, Bhubaneswar

India

SMS Medical College, Jaipur

India

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Other files	version 3	30/01/2026	12/02/2026	No	No
Participant information sheet	version 4	28/01/2026	06/02/2026	No	Yes
Participant information sheet	version 3	30/01/2026	06/02/2026	No	Yes
Protocol file	version 2	30/01/2026	06/02/2026	No	No

Additional files

48989_PIS Delivery PIL_V4_28Jan2026.pdf: Participant information sheet
48989_PIS_Consent Form_v3_30Jan2026.pdf: Participant information sheet
48989_Protocol_v2_30Jan2026.pdf: Protocol file
48989_Delivery Consent Form_v3_30Jan2026.pdf: Other files

Editorial Notes

13/02/2026: Study's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).