Perineal InjuryNCT05268276
Designed Protocol of Care for Postpartum Perineal Trauma
A study testing 1-perineal ice-gel pad application, 2-performance of pelvic floor exercises (Kegel exercises) and 3- perineal warm compresses application in people with Perineal Injury, run by Asmaa Abdallah Ahmed Hussein at 1 site in Egypt.
Trial summary
the study is intended to test the effect of designed protocol of care that include perineal ice-gel pad application, performance of pelvic floor exercises (Kegel exercises) and perineal warm compresses application on the outcomes of postpartum perineal trauma among women with vaginal delivery at postpartum ward.To… Read more about this study
- Who is it for?
- Ages Up to 40 years, women only
- Conditions the study is for
- Perineal Injury
- What is being tested?
- 1-perineal ice-gel pad application, 2-performance of pelvic floor exercises (Kegel exercises) and 3- perineal warm compresses application
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2021to 9 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- primiparous or 2nd. multiparaous women with postpartum perineal trauma either episiotomy or perineal tear (first and second degree only)
- age not exceeding 40 years
- body mass index (BMI)within normal 18.5-24.9 kg/m2 or overweight 25-29.9 kg/m2,
- free from any high risk condition affecting perineal trauma healing (e.g., diabetes mellitus or obesity),
- over 37 week gestation
- not having any complications during labor and delivery(e.g., abnormal presentation, obstructed labor or delivered with instrument),
- not having any immediate postnatal complications such as postpartum hemorrhage.
Who cannot join
- 3rd or 4th degree perineal tear
- obesity.
- age more than 40 years
- having any complications during labor and delivery(e.g., abnormal presentation, obstructed labor or delivered with instrument)
- having any immediate postnatal complications such as postpartum hemorrhage. ]
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of nursing/Cairo university& Kasr El Aini University Hospital
Cairo, El-manial, 11553
About this study
Official title: The Effect of Designed Protocol of Care on the Outcomes of Postpartum Perineal Trauma: a Randomized Controlled Trial (RCT)
the study is intended to test the effect of designed protocol of care that include perineal ice-gel pad application, performance of pelvic floor exercises (Kegel exercises) and perineal warm compresses application on the outcomes of postpartum perineal trauma among women with vaginal delivery at postpartum ward.To fulfill the aim of this study the following research hypothesis is formulated: H1: Post partum women with perineal trauma who will receive the designed protocol of care will have better perineal trauma outcomes than those who will receive the routine hospital care.Sub-hypothesis 1: Postpartum women with perineal trauma who will receive the designed protocol of care will show better perineal trauma healing than those who will receive the routine hospital care.
Sub-hypothesis 2: Postpartum women with perineal trauma who will receive the designed protocol of care will have less perineal pain score than those who will receive the routine hospital care.
Read the detailed description
This randomized controlled trial will be conducted to test the effect of designed protocol of care that include; perineal ice-gel pad application for the first 24 hours after delivery, performance of pelvic floor exercises (Kegel exercises) for six hours till one week postpartum and perineal warm compresses application from 48 hours till one week postpartum on the outcomes of postpartum perineal trauma .The study will be conducted on (100) postpartum women with normal spontaneous vaginal delivery and having postpartum perineal trauma that randomly assigned to either study group (50) women or control group (50) women.The study will be conducted at postpartum ward of emergency department for labor and delivery in Obstetrics and Gynecology Hospital at Kasr El Aini University Hospital affiliated to Cairo University.Required data will be collected by using 5 tools: A) Structured interview schedule; B) Visual Analogue Scale for pain intensity(VAS); C) Visual Analogue Scale (VAS) for rating functional activities; D) Standardized REEDA scale; and E) Postpartum follow up sheet. the primary official permission will be obtained from the research ethics committee of faculty of nursing, Cairo University to approve the tools and the study. An official permission will be granted from the hospital administrative personnel in the recommended setting to collect the data. Then, data collection will be carried out through five steps in each group: Recruitment \& randomization; interviewing; initial assessment; intervention; follow up and monitoring.
- Conditions
- Perineal Injury
- Being tested
- 1-perineal ice-gel pad application, 2-performance of pelvic floor exercises (Kegel exercises), 3- perineal warm compresses application
- Keywords
- perineal trauma, outcomes, pospartum, protocol of care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-perineal ice-gel pad applicationOther
For the study group Immediately after delivery (within 30 minutes to one hour after delivery), an ice gel pad will be applied to perineal trauma. each gel pad will have fixed standardized diameter (an approximately 5 cm width, 23 cm length, and 1.5 cm thickness) and approved by Egyptian ministry of health. It will be kept in the freezer for 45-60 minutes and will be removed when frozen. Then, it will be wrapped in a sterile pad and applied to cover the perineum and anal region.The investigator will provide a clear and concise information through oral and written instructions about the following; 1) The ice gel pad's purpose, benefits, anticipated effects and how to apply it, 2) Apply the ice gel pad on perineum after birth within 30 minutes to an hour, 3) Instruct the women to apply the ice gel pad for about 20 minutes every two hours during the first 24 hours postpartum only
2-performance of pelvic floor exercises (Kegel exercises)Other
women will receive instructions to practice pelvic floor exercises (Kegel exercises) and will be asked to perform these exercises from 6 hours postpartum and continue at home till one week. Before applying the technique, the investigator will teach the women how to recognize the accurate muscle, whereby she imagines holding passing gases or trying to stop the flow of urine midstream at the same time. The women will be taught to insert a clean finger into the vagina before practicing the exercises and if the women feeling pressure around her finger, she is on the right track, . The investigator will perform vaginal examination while the woman is doing the pelvic floor exercises (Kegel exercises) to ensure correct use of muscles. The investigator will instruct the women to continue contracting the muscles for about 5 seconds and then to loosen them for 5 seconds and repeat it for five times each set, perform at least five sets per day
3- perineal warm compresses applicationOther
women will be instructed to apply warm compresses on perineal trauma 48 hours postpartum at home. This will be done by using a clean pad soaked in warm water and squeezed to remove excess water then placed gently on the perineum, the warm compresses will be applied for 15 minutes three times per day (every 8 hours), and water in the bowl will be replaced with every application. Women will be asked to apply warm compresses on perineal trauma from 48 hours postpartum till one week.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | the study group will recelve adesigned protocol of care that entails three interventions as the following1) Application of ice gel pad on perineal trauma for the first 24 hours post partum 2) Performance of pelvic floor exercises (Kegel exercises) from six hours till one week postpartum 3) Application of warm compresses after 48 hours and through the first week postpartum.
The investigator will perform demonstration and then redemonstration by the women on each intervention will be done. A designed booklet (developed previously) that explains each intervention will be given to each woman. Receives: Other: 1-perineal ice-gel pad application; Other: 2-performance of pelvic floor exercises (Kegel exercises); Other: 3- perineal warm compresses application |
| control group | No intervention | The control group will receive the routine hospital care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Postpartum Perineal Pain
Postpartum severity of perineal pain will be assessed by Visual Analogue Scale for pain intensity (VAS).It is a self-reported 10 cm horizontal line which represents the subjective estimation of pain intensity. It comprises 0-10-point numerical scale, the two opposite ends representing no pain to severe pain as follows: no pain (0), mild pain (< 4), moderate pain (4 - < 8), and sever pain (8-10).
Measured: one hour after delivery, six hours after delivery, 24 hours after delivery, day 3 after delivery, day 5 after delivery, day 7 after delivery
Postpartum Perineal Trauma Healing
Postpartum perineal trauma healing will be assessed by standardized Redness,Edema,Echymosis,Discharge,Approximation of sutures( REEDA) scale.The total score ranged from 0 to 15 and categorized as the following; 0 to 2 good wound healing , 3 to 5 moderate wound healing, 6 to 8 mild wound healing, and 9 to 15 poor wound healing . the lower score 0 and the maximum score 15 , as the score decreases it indicate better wound healing
Measured: one hour after delivery, six hours after delivery, day 7after delivery
Secondary outcomes (2)
Occurrence of Postpartum Perineal Trauma Infection
Postpartum perineal trauma infection will be assessed by standardized REEDA scale.
the score ranged from 0-15 , score from 0 to 2 indicates no wound infection,while from 3-15 indicates wound infection
Measured: day 7 after delivery
Postpartum Difficulty With Performing Functional Activity
postpartum difficulty with performing functional activity as (turning/rolling in bed, getting out of bed, sitting, walking, defecation and urination) will be assessed using Visual Analogue Scale for rating functional activity.The scoring for each activity will be as follows: no difficulty (0), mild difficulty (< 4), moderate difficulty (4 - <8), and sever difficulty (8-10). The total score will be recorded (0-60 point), the lowest score (0) indicate no difficulties and the maximum score (60) indicate maximum difficulty. The total score will be interpreted as the following no difficulties (0), Mild difficulties (1 - < 24), Moderate difficulties (24 - < 48), Sever difficulties (48-60).
Measured: 24 hours after delivery, day 3 after delivery, day 5 after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start10 Oct 2021
- Primary completion15 Mar 2022
- Study completion9 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Perineal InjuryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- after obtaining the primary and official permission data collection will be carried out through five steps in each group: Recruitment \& randomization; interviewing; initial assessment; intervention; follow up and monitoring. : For the study group the intervention will be according to a designed protocol of care that entails; 1) Application of ice gel pad on perineal trauma for the first 24 hours post partum; 2) Performance of pelvic floor exercises (Kegel exercises) from six hours till one week postpartum; 3) Application of warm compresses after 48 hours and through the first week postpartum. The investigator will perform demonstration and then redemonstration by the women on each intervention will be done. A designed booklet (developed previously) that explains each intervention will be given to each woman.The control group will receive the routine hospital care only
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asmaa Abdallah Ahmed Hussein
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Asmaa Abdallah Ahmed Hussein, Cairo University
- Investigators
- Asmaa Abdallah, Principal investigator, Cairo UniversityYousria Ahmed, Study director, Cairo UniversityShadia Abdel Kader, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268276
- Sponsor's protocol ID
- Asmaa Abdallah Ahmed Hussein
- Status last verified
- Mar 2025
- First submitted
- 27 Dec 2021
- Last updated
- 19 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Designed Protocol of Care on the Outcomes of Postpartum Perineal Trauma: a Randomized Controlled Trial (RCT)
- ClinicalTrials.gov ID
- NCT05268276
- Acronym / sponsor ID
- Asmaa Abdallah Ahmed Hussein
- Conditions
- Perineal Injury
- Keywords
- perineal trauma, outcomes, pospartum, protocol of care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Asmaa Abdallah Ahmed HusseinUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 9 Mar 2023 (actual)
- First posted
- 7 Mar 2022 (actual)
- Results
- Posted 27 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the study is intended to test the effect of designed protocol of care that include perineal ice-gel pad application, performance of pelvic floor exercises (Kegel exercises) and perineal warm compresses application on the outcomes of postpartum perineal trauma among women with vaginal delivery at postpartum ward.To fulfill the aim of this study the following research hypothesis is formulated: H1: Post partum women with perineal trauma who will receive the designed protocol of care will have better perineal trauma outcomes than those who will receive the routine hospital care.Sub-hypothesis 1: Postpartum women with perineal trauma who will receive the designed protocol of care will show better perineal trauma healing than those who will receive the routine hospital care.
Sub-hypothesis 2: Postpartum women with perineal trauma who will receive the designed protocol of care will have less perineal pain score than those who will receive the routine hospital care.
Detailed description
This randomized controlled trial will be conducted to test the effect of designed protocol of care that include; perineal ice-gel pad application for the first 24 hours after delivery, performance of pelvic floor exercises (Kegel exercises) for six hours till one week postpartum and perineal warm compresses application from 48 hours till one week postpartum on the outcomes of postpartum perineal trauma .The study will be conducted on (100) postpartum women with normal spontaneous vaginal delivery and having postpartum perineal trauma that randomly assigned to either study group (50) women or control group (50) women.The study will be conducted at postpartum ward of emergency department for labor and delivery in Obstetrics and Gynecology Hospital at Kasr El Aini University Hospital affiliated to Cairo University.Required data will be collected by using 5 tools: A) Structured interview schedule; B) Visual Analogue Scale for pain intensity(VAS); C) Visual Analogue Scale (VAS) for rating functional activities; D) Standardized REEDA scale; and E) Postpartum follow up sheet. the primary official permission will be obtained from the research ethics committee of faculty of nursing, Cairo University to approve the tools and the study. An official permission will be granted from the hospital administrative personnel in the recommended setting to collect the data. Then, data collection will be carried out through five steps in each group: Recruitment \& randomization; interviewing; initial assessment; intervention; follow up and monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- after obtaining the primary and official permission data collection will be carried out through five steps in each group: Recruitment \& randomization; interviewing; initial assessment; intervention; follow up and monitoring. : For the study group the intervention will be according to a designed protocol of care that entails; 1) Application of ice gel pad on perineal trauma for the first 24 hours post partum; 2) Performance of pelvic floor exercises (Kegel exercises) from six hours till one week postpartum; 3) Application of warm compresses after 48 hours and through the first week postpartum. The investigator will perform demonstration and then redemonstration by the women on each intervention will be done. A designed booklet (developed previously) that explains each intervention will be given to each woman.The control group will receive the routine hospital care only
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: 1-perineal ice-gel pad application, Other: 2-performance of pelvic floor exercises (Kegel exercises), Other: 3- perineal warm compresses applicationthe study group will recelve adesigned protocol of care that entails three interventions as the following1) Application of ice gel pad on perineal trauma for the first 24 hours post partum 2) Performance of pelvic floor exercises (Kegel exercises) from six hours till one week postpartum 3) Application of warm compresses after 48 hours and through the first week postpartum. The investigator will perform demonstration and then redemonstration by the women on each intervention will be done. A designed booklet (developed previously) that explains each intervention will be given to each woman. |
| control group | No intervention | –The control group will receive the routine hospital care only |
Who may qualify
- Ages
- Up to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
Key exclusion criteria (5 listed)
- 3rd or 4th degree perineal tear
- obesity.
- age more than 40 years
- having any complications during labor and delivery(e.g., abnormal presentation, obstructed labor or delivered with instrument)
- having any immediate postnatal complications such as postpartum hemorrhage. ]
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 |
|---|---|---|
| 1-perineal ice-gel pad applicationFor the study group Immediately after delivery (within 30 minutes to one hour after delivery), an ice gel pad will be applied to perineal trauma. each gel pad will have fixed standardized diameter (an approximately 5 cm width, 23 cm length, and 1.5 cm thickness) and approved by Egyptian ministry of health. It will be kept in the freezer for 45-60 minutes and will be removed when frozen. Then, it will be wrapped in a sterile pad and applied to cover the perineum and anal region.The investigator will provide a clear and concise information through oral and written instructions about the following; 1) The ice gel pad's purpose, benefits, anticipated effects and how to apply it, 2) Apply the ice gel pad on perineum after birth within 30 minutes to an hour, 3) Instruct the women to apply the ice gel pad for about 20 minutes every two hours during the first 24 hours postpartum only | Other | study group |
| 2-performance of pelvic floor exercises (Kegel exercises)women will receive instructions to practice pelvic floor exercises (Kegel exercises) and will be asked to perform these exercises from 6 hours postpartum and continue at home till one week. Before applying the technique, the investigator will teach the women how to recognize the accurate muscle, whereby she imagines holding passing gases or trying to stop the flow of urine midstream at the same time. The women will be taught to insert a clean finger into the vagina before practicing the exercises and if the women feeling pressure around her finger, she is on the right track, . The investigator will perform vaginal examination while the woman is doing the pelvic floor exercises (Kegel exercises) to ensure correct use of muscles. The investigator will instruct the women to continue contracting the muscles for about 5 seconds and then to loosen them for 5 seconds and repeat it for five times each set, perform at least five sets per day | Other | study group |
| 3- perineal warm compresses applicationwomen will be instructed to apply warm compresses on perineal trauma 48 hours postpartum at home. This will be done by using a clean pad soaked in warm water and squeezed to remove excess water then placed gently on the perineum, the warm compresses will be applied for 15 minutes three times per day (every 8 hours), and water in the bowl will be replaced with every application. Women will be asked to apply warm compresses on perineal trauma from 48 hours postpartum till one week. | Other | study group |
Primary outcome
Severity of Postpartum Perineal Pain
Time frame: one hour after delivery, six hours after delivery, 24 hours after delivery, day 3 after delivery, day 5 after delivery, day 7 after delivery
Postpartum severity of perineal pain will be assessed by Visual Analogue Scale for pain intensity (VAS).It is a self-reported 10 cm horizontal line which represents the subjective estimation of pain intensity. It comprises 0-10-point numerical scale, the two opposite ends representing no pain to severe pain as follows: no pain (0), mild pain (< 4), moderate pain (4 - < 8), and sever pain (8-10).
Postpartum Perineal Trauma Healing
Time frame: one hour after delivery, six hours after delivery, day 7after delivery
Postpartum perineal trauma healing will be assessed by standardized Redness,Edema,Echymosis,Discharge,Approximation of sutures( REEDA) scale.The total score ranged from 0 to 15 and categorized as the following; 0 to 2 good wound healing , 3 to 5 moderate wound healing, 6 to 8 mild wound healing, and 9 to 15 poor wound healing . the lower score 0 and the maximum score 15 , as the score decreases it indicate better wound healing
2 secondary outcomes
Occurrence of Postpartum Perineal Trauma Infection
Time frame: day 7 after delivery
Postpartum Difficulty With Performing Functional Activity
Time frame: 24 hours after delivery, day 3 after delivery, day 5 after delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Asmaa Abdallah principal investigator
Cairo University
Yousria Ahmed study director
Cairo University
Shadia Abdel Kader study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1-perineal ice-gel pad application, 2-performance of pelvic floor exercises (Kegel exercises) and 3- perineal warm compresses application in people with Perineal Injury, run by Asmaa Abdallah Ahmed Hussein at 1 site in Egypt.
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 7 inclusion and 5 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 19 Mar 2025. 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 Egypt. 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?
Yes. Results are posted in the registry (first posted 27 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Severity of Postpartum Perineal Pain (time frame: one hour after delivery, six hours after delivery, 24 hours after delivery, day 3 after delivery, day 5 after delivery, day 7 after delivery). The study lists 2 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 19 Mar 2025.