An interventional study of nursing care bundle in Perineal Trauma, sponsored by Al-Quds University. Completed at 1 site in Palestinian Territories. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-01.
Sponsored by Al-Quds University · Not applicable, Interventional, and Prevention
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).
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.
Al-Quds University is the lead sponsor of 20 studies on the registry; 4 are open to participants now.
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The age range was from 18-35 years
Exclusion Criteria:
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
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
Time frame: up to 5 months
Assessment of Maternal Outcomes
Perineal pain severity using Pain Numeric Rating Scale from 0 to 10
Time frame: up to 5 months
Newborn Outcomes
Assessment of Newborn Outcomes (This part evaluated neonatal outcomes: newborn birth weight in Kg was recorded.
Time frame: up to 5 months
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Al-Quds University