Effect of Nursing Care Bundle Upon Perineal Trauma Reduction and Birth Outcomes During Vaginal Birth

NCT07505524 | Completed

• 1 other identifier: Research Code 114-h
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate the effect of implementing a nursing care bundle upon perineal trauma reduction and birth outcomes during vaginal birth. A quasi-experimental design was employed. A purposive sample of 80 primiparous women was recruited and equally divided into a study group (n = 40) and a control group (n = 40).

Conditions

Perineal Trauma

Keywords

Perineal Trauma; Birth Outcomes; Vaginal Birth.

Outcome Measures

Primary Outcomes (3)

• Perineal Trauma Reduction using (Perineal trauma Observational Checklist)

  This tool was adopted from Sultan (1999) and later published by the Committee on Practice Bulletins-Obstetrics (2018), Roper et al. (2020), and the Royal College of Obstetricians and Gynaecologists (RCOG, 2015). It was used to observe, assess, and classify the degree of perineal trauma before and after the intervention. Classification of Perineal Trauma Degree Description Intact No visible tear. First Degree Injury to the perineal skin and/or vaginal mucosa. Second Degree Injury to the perineum involving the perineal muscles but not involving the anal sphincter. Third Degree Injury to the perineum involving the anal sphincter complex. Subdivided into: 3a \< 50% of external anal sphincter (EAS) thickness torn. 3b\> 50% of external anal sphincter (EAS) thickness torn. Both external anal sphincter (EAS) and internal anal sphincter (IAS) torn. Fourth Degree Injury involving EAS, IAS, and anorectal

  up to 5 months

• Assessment of Maternal Outcomes

  Perineal pain severity using Pain Numeric Rating Scale from 0 to 10

  up to 5 months

• Newborn Outcomes

  Assessment of Newborn Outcomes (This part evaluated neonatal outcomes: newborn birth weight in Kg was recorded.

  up to 5 months

Study Arms (1)

nursing care bundles

EXPERIMENTAL

Other: nursing care bundle

Interventions

nursing care bundle OTHER

A nursing care bundle could enhance early detection, prevent undiagnosed injuries, improve maternal outcomes, and reduce medico-legal risks. Therefore, evaluating the effectiveness of a nursing care bundle on reducing perineal trauma and improving birth outcomes during vaginal delivery is crucial, particularly for primiparous women

nursing care bundles

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Pregnant Women- Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The age range was from 18-35 years
• Pregnant with a single viable fetus
• to 42 weeks of gestation, primipara
• Free from antenatal or preexisting medical conditions that predispose to a complicated birth
• Whose fetus have not been diagnosed prior to labor to be at risk of complications (as congenital malformations, intrauterine growth restriction, and placental problems).

Sponsors & Collaborators

• Al-Quds University: lead

Study Sites (1)

Al-Quds University

East Jerusalem, Palestinian Territories

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: April 1, 2026
• Study Start: May 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

PA (1)