NCT05021692

Brief Summary

In the literature, it has been reported that health promotion model-based care approaches are beneficial in gaining positive healthy lifestyle behaviors, taking responsibility for the individual's health and increasing the quality of life. It is thought that the health promotion model in pregnant women with preeclampsia will positively affect the healthy lifestyle behaviors and self-efficacy level of pregnant women by ensuring active participation of pregnant women in symptom management, reduce the stress of the pregnant and positively affect maternal and fetal-neonatal health outcomes. In line with this information, it was aimed to determine the effect of the web-based support program based on the health promotion model on maternal infant health in pregnant women with preeclampsia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2023

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

1.5 years

First QC Date

July 10, 2021

Last Update Submit

August 24, 2021

Conditions

Keywords

healthy lifeweb-based supportrisky pregnancypreeclampsia

Outcome Measures

Primary Outcomes (2)

  • Web-based support program based on the Health Promotion Model positively affects fetal-neonatal health outcomes.

    The mother feels at least 10 movements in two hours in the follow-up of the baby movements. Postpartum first and fifth minute Apgar score is seven or more out of 10 points. The newborn did not need intensive care support. The newborn had no respiratory distress.

    6-12 months

  • The web-based support program based on the Health Promotion Model reduces the stress of pregnant women regarding their own and their baby's health.

    There was a decrease in the scores of the pregnant women in the intervention group from the Prenatal Distress Scale, and the pregnant women in the intervention group had a statistically lower score on the Prenatal Distress Scale than the pregnant women in the control group.

    6-12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention group: Pregnant women with preeclampsia who receive a web-based support program based on the Health Promotion Model in addition to routine clinical care will form the intervention group.

Behavioral: Web-based support program for pregnant women with preeclampsia based on the Health Promotion Model

Control

NO INTERVENTION

Pregnant women who receive routine clinical care applied to pregnant women with preeclampsia will constitute the control group.

Interventions

support program

Also known as: Routine clinical care applied to pregnant women with preeclampsia
Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having been diagnosed with preeclampsia
  • Having internet access
  • Being older than the 20th gestational week
  • Over the age of 18
  • Having a single live fetus
  • No diagnosed psychiatric disease
  • Being literate
  • Being willing to participate in the study.

You may not qualify if:

  • Not having internet access or not knowing how to use it
  • Having an accompanying chronic disease
  • Inability to communicate in Turkish
  • Having inpatient treatment at the hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Büşra Yılmaz

Istanbul, Sisli, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Asci O, Rathfisch G. Effect of lifestyle interventions of pregnant women on their dietary habits, lifestyle behaviors, and weight gain: a randomized controlled trial. J Health Popul Nutr. 2016 Feb 24;35:7. doi: 10.1186/s41043-016-0044-2.

MeSH Terms

Conditions

Pre-EclampsiaKidney Diseases

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrologic DiseasesFemale Urogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Prospective, single-blind, randomized-controlled type experimental study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc, Research Assistant

Study Record Dates

First Submitted

July 10, 2021

First Posted

August 25, 2021

Study Start

March 25, 2021

Primary Completion

September 15, 2022

Study Completion

January 15, 2023

Last Updated

August 25, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations