NCT06290700

Brief Summary

This study aimed to evaluate the effect of neonatal care education for primiparous pregnant women on postpartum maternal function and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 4, 2024

Completed
Last Updated

March 4, 2024

Status Verified

February 1, 2024

Enrollment Period

1.3 years

First QC Date

February 26, 2024

Last Update Submit

February 26, 2024

Conditions

Keywords

functional statuslife qualitymothersPregnancy

Outcome Measures

Primary Outcomes (1)

  • severity of maternal function by Barkin Index of Maternal Functioning

    The scale was used 6 weeks after childbirth

    10 weeks after after the intervention

Secondary Outcomes (1)

  • Maternal Postpartum Quality of Life Instrument

    10 weeks after after the intervention

Study Arms (2)

İntervational group

EXPERIMENTAL

Neonatal care education given to primiparous pregnant women affect their postpartum maternal function Neonatal care education given to primiparous pregnant women affect their postpartum quality of life?

Behavioral: Neonatal Care education

Control group

NO INTERVENTION

All pregnant women, those in the control group, were provide with standard

Interventions

Participants who met the study inclusion criteria were provided with information about the purpose and conduct of the study, and their consent to participate was then obtained. The interviews were conducted in the breastfeeding room at the Uşak Dikilitaş Family Health Centre. The data were collected between November 2022 and November 2023. The Family Health Centre has two vaccination rooms, two antenatal care rooms, two observation rooms, and two breastfeeding rooms. Each pregnant woman was individually enrolled in an education session held in the breastfeeding room. The breastfeeding room was approximately 20 m², which was considered standard for accommodating training for an average of three pregnant women. The breastfeeding room was quiet, had a suitable temperature, and was located on the first floor in the middle of the corridor.

İntervational group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being at least a primary school graduate.
  • Being a primiparous pregnant woman.
  • Being able to provide feedback.

You may not qualify if:

  • Being a multiparous pregnant woman.
  • Being a high-risk pregnant woman.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonca ÇIÇEK OKUYAN

Manisa, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2024

First Posted

March 4, 2024

Study Start

November 1, 2022

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

March 4, 2024

Record last verified: 2024-02

Locations