Perineal TraumaNCT07505524
Effect of Nursing Care Bundle Upon Perineal Trauma Reduction and Birth Outcomes During Vaginal Birth
A study testing nursing care bundle in people with Perineal Trauma, run by Al-Quds University at 1 site in Palestinian Territories.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perineal Trauma
- What is being tested?
- nursing care bundle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 1 May 2025to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- • 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).
Who cannot join
- Other vs the inclusion
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site
Al-Quds University
East Jerusalem
About this study
Official title: 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).
Read the 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.
- Conditions
- Perineal Trauma
- Being tested
- nursing care bundle
- Keywords
- Perineal Trauma, Birth Outcomes, Vaginal Birth.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nursing care bundleOther
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
| Study group | Role | What they receive |
|---|---|---|
| nursing care bundles | Experimental | Not described Receives: Other: nursing care bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 5 months
Assessment of Maternal Outcomes
Perineal pain severity using Pain Numeric Rating Scale from 0 to 10
Measured: up to 5 months
Newborn Outcomes
Assessment of Newborn Outcomes (This part evaluated neonatal outcomes: newborn birth weight in Kg was recorded.
Measured: up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start1 May 2025
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perineal TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Quds University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashraf Jehad Abuejheisheh, Al-Quds University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505524
- Sponsor's protocol ID
- Research Code 114-h
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Implementing Nursing Care Bundle Upon Perineal Trauma Reduction and Birth Outcomes During Vaginal Birth
- ClinicalTrials.gov ID
- NCT07505524
- Acronym / sponsor ID
- Research Code 114-h
- Conditions
- Perineal Trauma
- Keywords
- Perineal Trauma, Birth Outcomes, Vaginal Birth.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Al-Quds UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nursing care bundles | Experimental | Other: nursing care bundle |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • The age range was from 18-35 years
Key exclusion criteria (1 listed)
- Other vs the inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nursing care bundleA 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 | Other | nursing care bundles |
Primary outcome
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
Assessment of Maternal Outcomes
Time frame: up to 5 months
Perineal pain severity using Pain Numeric Rating Scale from 0 to 10
Newborn Outcomes
Time frame: up to 5 months
Assessment of Newborn Outcomes (This part evaluated neonatal outcomes: newborn birth weight in Kg was recorded.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nursing care bundle in people with Perineal Trauma, run by Al-Quds University at 1 site in Palestinian Territories.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Palestinian Territories. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perineal Trauma Reduction using (Perineal trauma Observational Checklist) (time frame: up to 5 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.