Skip to content

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07505524
Enrollment
80
Registered
2026-04-01
Start date
2025-05-01
Completion date
2025-10-01
Last updated
2026-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perineal Trauma

Keywords

Perineal Trauma, Birth Outcomes, Vaginal Birth.

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).

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.

Interventions

OTHERnursing 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

Sponsors

Al-Quds University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Perineal Trauma Reduction using (Perineal trauma Observational Checklist)up to 5 monthsThis 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
Assessment of Maternal Outcomesup to 5 monthsPerineal pain severity using Pain Numeric Rating Scale from 0 to 10
Newborn Outcomesup to 5 monthsAssessment of Newborn Outcomes (This part evaluated neonatal outcomes: newborn birth weight in Kg was recorded.

Countries

Palestinian Territories

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026