ClinicalTrials.gg
RecruitingNCT07185204PREDiCT-NPLUpdated Jul 20, 2026

Postpartum Preeclampsia Early Detection and Treatment: Nepal Pilot Study

An interventional study of Early detection and management of postpartum preeclampsia bundle in Postpartum Preeclampsia, sponsored by Medical College of Wisconsin. Recruiting at 2 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-20.

Sponsored by Medical College of Wisconsin · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Mar 2026; still recruiting 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 228 studies in Pre-Eclampsia with a site in United States — 60 open to participants now, 76 under way, 6 of them phase 3. Pre-Eclampsia · United States.

Planned enrollment
94th of 159
60 · median 89
Started
2026
with 27 others
No phase
71 of 228
17 open now
Primary completion
2027-06
later than 38 of 75 live
Registered
203rd of 228
by date
Lead sponsor
6 of 228
Medical College of Wisconsin

Among the 228 studies in Pre-Eclampsia with a site in United States, this one is the 94th largest by planned enrollment of the 159 interventional ones, is one of 28 that started in 2026, is one of 71 with no phase, reaches primary completion later than 38 of the 75 other live ones, and was the 203rd registered.

By phase

228 studies; the count open now beside each. This study's row is marked.

No phasethis study71 · 17 open
Observational69 · 14 open
Phase 431 · 11 open
Phase 121 · 6 open
Phase 218 · 7 open
Phase 312 · 4 open
Phase 1/23 · 1 open
Phase 2/33 · 0 open

By the year they started

First in 2000; this study’s year is marked. 28 started in 2026.

Size and results

Median enrollment 89 across the 159 interventional studies, 125 across the 69 observational. Of the 126 that completed or were terminated, 54 (43%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 228 studies in Pre-Eclampsia with a site in United States, or all of them as a file.
02

Study summary

The goal of this study is to address the significant morbidity associated with preeclampsia diagnosed after delivery. All participants will undergo biomarker evaluation with soluble fms-like tyrosine kinase-1 and placental growth factor (sFlt-1/PlGF) ratio testing before delivery to assess the predictive ability of these biomarkers with new-onset postpartum preeclampsia. High-risk participants will be randomized to a bundle of care strategies aimed at early detection and management of postpartum preeclampsia.

Read the detailed description

This is a pilot randomized controlled trial of 60 normotensive, pregnant patients randomized to early monitoring and management for postpartum preeclampsia after biomarker evaluation with sFlt-1/PlGF ratio. After obtaining informed consent, participants will undergo preeclampsia risk assessment using sFlt-1/PlGF ratio testing prior to delivery. Patients with a low risk ratio will receive routine postpartum care. Patients with a high risk ratio will be randomized 1:1 to the intervention bundle focused on early detection and management of postpartum preeclampsia versus routine postpartum care. The intervention bundle will include remote blood pressure monitoring, education, and dispensing antihypertensive medication (nifedipine ER) for outpatient management of asymptomatic, mild-range BP. The primary outcome is the feasibility of all study procedures, measured by recruitment, retention, adherence, and acceptability. The secondary outcome is to assess the effect of early monitoring and management of postpartum preeclampsia on the composite outcome of hypertension requiring in-person medical evaluation and hypertension-related morbidity. Finally, the exploratory outcome is the predictive ability of sFlt-1/PlGF ratio of de novo postpartum preeclampsia in antenatally normotensive patients who are at risk for HDP based on ACOG/USPSTF criteria. Data on primary and secondary outcomes will be collected from both randomized groups and the non-randomized group with low-risk sFlt-1/PlGF ratio to determine the predictive capability of the test in the postpartum period.

03

Conditions studied

  • Postpartum Preeclampsia

Keywords

  • Preeclampsia
  • Hypertension
  • Pregnancy
  • Postpartum
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Pregnant patients ≥ 36 weeks gestation without major fetal anomalies
  • Age ≥ 18 years
  • Admitted for labor at Dhulikhel Hospital, or intend to deliver at Dhulikhel Hospital
  • At risk for preeclampsia, using the Clinical Risk Assessment for Preeclampsia according to ACOG and USPSTF

    • 1 or more high risk factors:

      • History of preeclampsia
      • Type 1 or 2 diabetes
      • Multifetal gestation?
      • Renal disease
      • disease
    • 2 or more moderate risk factors:

      • Nulliparity
      • > 30
      • First-degree relative with a history of preeclampsia
      • African American race
      • Low socioeconomic status
      • Age > 35 years
      • History of low birthweight or small for gestational age
      • Previous adverse pregnancy outcome
      • Interpregnancy interval > 10 years

Exclusion criteria

Exclusion Criteria:

  • Antenatal hypertensive disorder of pregnancy diagnosis, including gestational hypertension, preeclampsia, eclampsia, or HELLP syndrome, according to ACOG guidelines
  • Chronic hypertension, according to ACOG guidelines
  • Known allergy or to nifedipine
  • Inability or unwillingness to provide
  • Two or more blood pressures with an SBP ≥140 or DBP ≥90 after consent and prior to sFlt-1/PlGF testing (screen failure criteria)
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    High-risk Intervention

    Participants with high-risk sFlt-1/PlGF ratio randomized to early detection and management of postpartum preeclampsia with remote blood pressure monitoring, education, and dispensing antihypertensive medication (nifedipine ER) for outpatient management of asymptomatic, mild range BP.

    Other: Early detection and management of postpartum preeclampsia bundle

  • No intervention
    High-Risk Control

    Participants with high-risk sFlt-1/PlGF ratio randomized to standard postpartum care.

  • No intervention
    Low-risk Control

    Participants with low-risk sFlt-1/PlGF ratio will not be randomized, but will remain enrolled to assess the exploratory outcome of biomarker predictive ability.

Interventions

  • OtherEarly detection and management of postpartum preeclampsia bundle

    Remote blood pressure monitoring, education, and dispensing antihypertensive medication (nifedipine ER) for outpatient management of asymptomatic, mild range BP.

06

What researchers measure

Primary outcomes

  1. Study feasibility

    Assess study feasibility as measured by retention rate.

    Time frame: 1 year

Secondary outcomes

  1. Composite outcome of hypertension-related healthcare utilization and morbidity.

    Assess the effect of early monitoring and management of postpartum preeclampsia on the incidence of a composite outcome including hypertension requiring in-person medical evaluation and hypertension-related morbidity.

    Time frame: 4 weeks postpartum

  2. Predictive ability of sFlt-1/PlGF ratio for de novo postpartum preeclampsia

    Assess the sFlt-1/PlGF ratio predictive ability of de novo postpartum preeclampsia in antenatally normotensive patients.

    Time frame: 2 weeks postpartum

07

Study locations

1 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared since this is a pilot study with very small sample sizes in each randomization group.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Jun 2027, 15 months after the start.

Of 171 non-industry interventional studies with no phase under Pre-Eclampsia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's planned 15 months is below that.

Counting every sponsor, half of 176 studies reached it within 24 months; a quarter within 9 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 30, 2025
First posted
Sep 22, 2025
StartActual
Mar 3, 2026
Primary completionEst.
Jun 2027
CompletionEst.
Jun 2027
Last update
Jul 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07185204
Collaborators
Dhulikhel Hospital
Responsible party
Anna Palatnik, MD (Associate Professor, Medical College of Wisconsin) — Principal investigator
First posted
Sep 22, 2025
Start date
Mar 3, 2026
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Jul 20, 2026

Study contacts

Alyssa Hernandez, DO
Contact
alyhernandez@mcw.edu
4148055285
Anna Palatnik, MD
principal investigator · Medical College of Wisconsin

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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