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

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

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).

Study Overview

• Status: Completed
• Conditions: Perineal Trauma
• Intervention / Treatment: Other: nursing care bundle

Detailed Description

Background: Perineal trauma during vaginal birth is a common maternal morbidity that may negatively affect postpartum recovery, pain, and overall birth outcomes. Evidence-based intrapartum nursing interventions, such as warm perineal compresses and manual perineal protection, have been suggested as effective strategies to reduce the severity of perineal trauma; however, their implementation as a structured nursing care bundle requires further evaluation. Aim: This study aimed to evaluate the effect of implementing a nursing care bundle upon perineal trauma reduction and birth outcomes during vaginal birth. Design: A quasi-experimental design was employed. Setting: The study was conducted at the labor and delivery unit of the National Medical Institution in Damanhur, affiliated with the Ministry of Health and Population, El-Beheira Governorate, Egypt. A purposive sample of 80 primiparous women was recruited and equally divided into a study group (n = 40) and a control group (n = 40). The control group received routine hospital care, while the study group received the nursing care bundle during the second stage of labor. Tools: Data were collected using four tools: (I) Women's Labor Parameters Assessment Sheet, (II) Birth Outcome Record, (III) Perineal Trauma Observational Checklist, and (IV) Visual Analogue Scale for perineal pain assessment.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Palestinian Territories
  • East Jerusalem, Palestinian Territories
    • Al-Quds University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• • The age range was from 18-35 years

  • Pregnant with a single viable fetus
  • 38 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).

Exclusion Criteria:

• Other vs the inclusion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nursing care bundles	Other: nursing care bundle; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Al-Quds University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Actual): October 1, 2025
• Study Completion (Actual): October 1, 2025

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Birth Outcomes; Perineal Trauma; Vaginal Birth.
• Other Study ID Numbers: Research Code 114-h

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No