Clinical trial NCT05837962: Nursing Intervention for Knowledge and Self-care Behaviors in the Face of Hypertensive Disorders of Pregnancy
Official title: Feasibility and Acceptability of the Nursing Intervention "EducaTHE" to Improve Knowledge and Self-care Behaviors in the Face of Hypertensive Disorders of Pregnancy in Pregnant Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertensive Disorders of Pregnancy
Keywords: Knowledge,Self Care,Pregnancy,Nursing, Feasibility Studies
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hypertensive disorders of pregnancy (HDP) are a leading cause of maternal and fetal morbidity and mortality worldwide. The lack of knowledge and self-care behaviors by the pregnant woman in the face of THE could be associated with their appearance. This is a randomized controlled pilot trial type study, with a control group that will receive the usual prenatal care and an intervention group that will additionally receive the nursing intervention to improve knowledge and self-care behaviors in the face of HDP. Each group will include 30 pregnant women, for a total of 60 users. The level of knowledge and self-care behaviors will be assessed before and after the intervention.

Detailed description: Introduction: the World Health Organization (WHO) indicates that HDP are the third leading cause of maternal death worldwide; and in Latin America and the Caribbean they are positioned as the first cause. The evidence has described that limited or non-existent knowledge and the lack of self-care behaviors by the pregnant woman in the face of HDP are important conditions in the incidence of this obstetric complication. In this sense, nursing must design and implement intervention strategies that have a positive impact on knowledge and self-care behaviors in the face of HDP.

Objective: to determine the feasibility and acceptability of the "EducaTHE" nursing intervention to improve knowledge and self-care behaviors in the face of hypertensive disorders of pregnancy in pregnant women.

Methods: randomized controlled pilot trial experimental study with pregnant women assigned to an intervention group and a control group. The sample will consist of a total of 40 pregnant women, 20 in each of the study groups.

The intervention group will receive the usual education of prenatal control. The control group, in addition to the usual prenatal control information, will receive an educational, behavioral and motivational intervention related to HDP and their self-care behaviors. The intervention will be carried out in 4 sessions, on a weekly basis, in a face-to-face and group. In both groups, knowledge and self-care behaviors will be measured before and 4 weeks after the end of the intervention.

Randomization: the assignment will be carried out through a simple randomization process, with an intervention/control ratio 1:1, by means of a sequence of random numbers generated by a statistical program. The assignment will be given by one of the researchers who will not perform the intervention, nor the initial or final evaluation.

Expected results: feasibility and acceptability of the study in the context of perinatal maternal care

Eligibility criteria: Inclusion Criteria:

* Pregnant women enrolled in the prenatal care program of a health institution
* Pregnant women aged 18 years or older
* Pregnant women with a gestational age equal to or less than 24 weeks determined by the date of the last period or obstetric ultrasound.
* Pregnant women residing in the urban area.

Exclusion Criteria:

* Pregnant women with chronic conditions such as heart disease, renal disease, or diabetes mellitus.
* Pregnant women with a history or diagnosis at entry or during the study of HDP according to the classification of the American College of Obstetricians and Gynecologists (ACOG)
* Pregnant women who are participating in other educational studies or workshops/programs with similar themes to this study.
* Pregnant women scoring less than 24 points on the Mini-mental status test.

Primary outcomes:
measure: Feasibility: recruitment, attrition, follow-up
timeFrame: 6 months
measure: Acceptability
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Santander
country: Colombia
facility: Local Hospital of Piedecuesta
state: Piedecuesta
Study officials:
affiliation: Universidad de Antioquia
name: Edier Arias Rojas
role: STUDY_DIRECTOR
affiliation: Universidad de Antioquia
name: Iliana Ulloa Sabogal
role: PRINCIPAL_INVESTIGATOR
References: