Normal Vaginal DeliveryNCT06921200
Effect of Perineal Cryotherapy on Episiotomy
A study testing Cryotherapy in people with Normal Vaginal Delivery and Perineal Episiotomy, run by Mansoura University.
Trial summary
The present study aims to evaluate the effect of perineal cryotherapy on episiotomy- associated pain among postpartum women. The study hypothesis: Post-partum women who apply perineal cryotherapy have lower level of episiotomy- associated pain than those who don't apply. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Normal Vaginal Delivery, Perineal Episiotomy
- What is being tested?
- Cryotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Postpartum mothers who are in a good health immediately after giving delivery.
- Having an episiotomy and a normal vaginal birth.
- Having a vaginal birth at full term.
- The delivery of a healthy single fetus having normal weight and vertex presentation.
Who cannot join
- Women who are experiencing labor or complications after giving birth, such as hemorrhage, a tear, or a cut in the perineum.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Perineal Cryotherapy on Episiotomy- Associated Pain Among Postpartum Women
The present study aims to evaluate the effect of perineal cryotherapy on episiotomy- associated pain among postpartum women.
The study hypothesis: Post-partum women who apply perineal cryotherapy have lower level of episiotomy- associated pain than those who don't apply.
Read the detailed description
The present study included postpartum mothers who are in a good health immediately after giving delivery, having an episiotomy and a normal vaginal birth of a single, full term, healthy baby with normal weight and vertex presentation.
- Conditions
- Normal Vaginal Delivery, Perineal Episiotomy
- Being tested
- Cryotherapy
- Keywords
- Episiotomy, Pain, Perineal cryotherapy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyProcedure or surgery
Cryotherapy is one of the non-pharmacological pain-relieving techniques, which involves chilling specific body areas with ice packs, ice cubes, ice water, or ethyl chloride sprays. The present study intervention will be conducted on 50 post-partum women to assist in relieve episiotomy pain. The researchers will assess the baseline level of episiotomy pain for each woman then the researchers will instruct women to perform perineal care. After cleaning the perineum, the researchers will ask the women to maintain her knee more flexed and apply ice gel pad against the episiotomy line for about 20 minutes then remove it and keep it in the freezer for reusing and assess the level of episiotomy pain using the Numeric Rating Scale for Pain after two hours from delivery. Ice gel pad will be applied for the second time after the episiotomy.
| Study group | Role | What they receive |
|---|---|---|
| Post-partum women who apply perineal cryotherapy after normal vaginal delivery with episiotomy | Experimental | Apply perineal cryotherapy after normal vaginal delivery with episiotomy (interventional group) Receives: Procedure: Cryotherapy |
| control group | No intervention | Postpartum women who receive routine episiotomy care after normal delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of episiotomy-associated pain
Measured: from enrollmet until four hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Vaginal DeliveryStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Ahmed Fadel, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921200
- Sponsor's protocol ID
- IRB. 0562
- Status last verified
- Feb 2025
- First submitted
- 3 Mar 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perineal Cryotherapy on Episiotomy- Associated Pain Among Postpartum Women
- ClinicalTrials.gov ID
- NCT06921200
- Acronym / sponsor ID
- IRB. 0562
- Conditions
- Normal Vaginal Delivery, Perineal Episiotomy
- Keywords
- Episiotomy, Pain, Perineal cryotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 10 Apr 2025 (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.
The present study aims to evaluate the effect of perineal cryotherapy on episiotomy- associated pain among postpartum women.
The study hypothesis: Post-partum women who apply perineal cryotherapy have lower level of episiotomy- associated pain than those who don't apply.
Detailed description
The present study included postpartum mothers who are in a good health immediately after giving delivery, having an episiotomy and a normal vaginal birth of a single, full term, healthy baby with normal weight and vertex presentation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-partum women who apply perineal cryotherapy after normal vaginal delivery with episiotomy | Experimental | Procedure: CryotherapyApply perineal cryotherapy after normal vaginal delivery with episiotomy (interventional group) |
| control group | No intervention | –Postpartum women who receive routine episiotomy care after normal delivery |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Postpartum mothers who are in a good health immediately after giving delivery.
- Having an episiotomy and a normal vaginal birth.
- Having a vaginal birth at full term.
- The delivery of a healthy single fetus having normal weight and vertex presentation.
Key exclusion criteria (1 listed)
- Women who are experiencing labor or complications after giving birth, such as hemorrhage, a tear, or a cut in the perineum.
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 |
|---|---|---|
| CryotherapyCryotherapy is one of the non-pharmacological pain-relieving techniques, which involves chilling specific body areas with ice packs, ice cubes, ice water, or ethyl chloride sprays. The present study intervention will be conducted on 50 post-partum women to assist in relieve episiotomy pain. The researchers will assess the baseline level of episiotomy pain for each woman then the researchers will instruct women to perform perineal care. After cleaning the perineum, the researchers will ask the women to maintain her knee more flexed and apply ice gel pad against the episiotomy line for about 20 minutes then remove it and keep it in the freezer for reusing and assess the level of episiotomy pain using the Numeric Rating Scale for Pain after two hours from delivery. Ice gel pad will be applied for the second time after the episiotomy. | Procedure or surgery | Post-partum women who apply perineal cryotherapy after normal vaginal delivery with episiotomy |
Primary outcome
Level of episiotomy-associated pain
Time frame: from enrollmet until four hours after delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy in people with Normal Vaginal Delivery and Perineal Episiotomy, run by Mansoura University.
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 4 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: opening soon, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eman A. Fadel, Assist. prof (+2 01002934749, e_a@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of episiotomy-associated pain (time frame: from enrollmet until four hours after delivery). 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 23 Sep 2025.