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

March 27, 2026 updated by: Ashraf Jehad Abuejheisheh, Al-Quds University

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: up to 5 months

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
Time Frame: up to 5 months
Perineal pain severity using Pain Numeric Rating Scale from 0 to 10
up to 5 months
Newborn Outcomes
Time Frame: up to 5 months
Assessment of Newborn Outcomes (This part evaluated neonatal outcomes: newborn birth weight in Kg was recorded.
up to 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Quds University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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