Women After Delivery With Perineal PainPhase 4NCT04464005
Comparison Between Pads With Cold Solution of Magnesium Sulfate or Cold Water Postpartum Perineal Pain and Healing
A Phase 4 study testing Magnesium sulfate 33% solution and Cold water in people with Women After Delivery With Perineal Pain, run by The Baruch Padeh Medical Center, Poriya at 1 site in Israel.
Trial summary
Perineal pain after delivery is common and is caused by local bruising or episiotomy. The pain may last for several days or months. Thus, several analgesic methods are offered. Topical magnesium sulfate 33% solution is a common treatment for perineal pain, wound treatment and alleviation of swelling. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Women After Delivery With Perineal Pain
- What is being tested?
- Magnesium sulfate 33% solution and Cold water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Nov 2023to 29 Sep 2025
- Phase
- Phase 4
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman after spontaneous or operative vaginal delivery
- Perineal pain score of at least 2 NRS
Who cannot join
- Women after cesarean delivery
- Refuse to participate
- Under 18 years of age
- Magnesium sulfate treatment not related to the study
- Contraindication for magnesium sulfate treatment
- Workers of the local obstetric department
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Pads With Cold Solution of Magnesium Sulfate or Cold Water to Treat Pain and Improve Healing of the Perineum After Vaginal Delivery. A Prospective, Randomized, Double-blind Controlled Study.
Perineal pain after delivery is common and is caused by local bruising or episiotomy. The pain may last for several days or months. Thus, several analgesic methods are offered. Topical magnesium sulfate 33% solution is a common treatment for perineal pain, wound treatment and alleviation of swelling. Yet, the efficacy of this treatment was not tested sufficiently in a clinical trials.
In the present study we will compare the efficacy of topical magnesium sulfate versus cold water for perineal pain and improved perineal healing after delivery.
Women after vaginal delivery (spontaneous or operative) with pain score of 3 in 0-10 numeric rating scale (NRS) will randomly be allocated to receive either pad with cold magnesium sulfate 33% solution or cold water. Pain score and healing parameters will be assessed at baseline, after one day of treatment and after two days of treatment.
- Conditions
- Women After Delivery With Perineal Pain
- Being tested
- Magnesium sulfate 33% solution, Cold water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfate 33% solutionDrug
Topical pads with cold magnesium sulfate 33% solution will be given 5 times/day for 15 minutes
Cold waterOther
Topical pads with cold water will be given 5 times/day for 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| Pads with cold magnesium sulfate 33% solution | Experimental | Not described Receives: Drug: Magnesium sulfate 33% solution |
| Pads with cold water | Placebo comparator | Not described Receives: Other: Cold water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of women with perineal pain score< 3 NRS at the day after treatment initiation
Measured: 24 hours post enrollment
Perineal pain intensity according to NRS scale at the day after treatment initiation
Measured: 24 hours post enrollment
Secondary outcomes (3)
Degree of perineal healing using the REEDA scale
Measured: 2 days
Perineal pain intensity according to NRS scale two days after treatment initiation
Measured: 2 days (if still in hospital)
Rate of women with improvement in hemorrhoids characteristics in women with hemorrhoids
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start15 Nov 2023
- Primary completion29 Sep 2025
- Study completion29 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women After Delivery With Perineal PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Baruch Padeh Medical Center, Poriya
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464005
- Sponsor's protocol ID
- 112-19
- Status last verified
- Sep 2026
- First submitted
- 5 Jul 2020
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Pads With Cold Solution of Magnesium Sulfate or Cold Water to Treat Pain and Improve Healing of the Perineum After Vaginal Delivery. A Prospective, Randomized, Double-blind Controlled Study.
- ClinicalTrials.gov ID
- NCT04464005
- Acronym / sponsor ID
- 112-19
- Conditions
- Women After Delivery With Perineal Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- The Baruch Padeh Medical Center, PoriyaOther government
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 29 Sep 2025 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 9 Jul 2020 (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.
Perineal pain after delivery is common and is caused by local bruising or episiotomy. The pain may last for several days or months. Thus, several analgesic methods are offered. Topical magnesium sulfate 33% solution is a common treatment for perineal pain, wound treatment and alleviation of swelling. Yet, the efficacy of this treatment was not tested sufficiently in a clinical trials.
In the present study we will compare the efficacy of topical magnesium sulfate versus cold water for perineal pain and improved perineal healing after delivery.
Women after vaginal delivery (spontaneous or operative) with pain score of 3 in 0-10 numeric rating scale (NRS) will randomly be allocated to receive either pad with cold magnesium sulfate 33% solution or cold water. Pain score and healing parameters will be assessed at baseline, after one day of treatment and after two days of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pads with cold magnesium sulfate 33% solution | Experimental | Drug: Magnesium sulfate 33% solution |
| Pads with cold water | Placebo comparator | Other: Cold water |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Woman after spontaneous or operative vaginal delivery
- Perineal pain score of at least 2 NRS
Key exclusion criteria (6 listed)
- Women after cesarean delivery
- Refuse to participate
- Under 18 years of age
- Magnesium sulfate treatment not related to the study
- Contraindication for magnesium sulfate treatment
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 |
|---|---|---|
| Magnesium sulfate 33% solutionTopical pads with cold magnesium sulfate 33% solution will be given 5 times/day for 15 minutes | Drug | Pads with cold magnesium sulfate 33% solution |
| Cold waterTopical pads with cold water will be given 5 times/day for 15 minutes | Other | Pads with cold water |
Primary outcome
Rate of women with perineal pain score< 3 NRS at the day after treatment initiation
Time frame: 24 hours post enrollment
Perineal pain intensity according to NRS scale at the day after treatment initiation
Time frame: 24 hours post enrollment
3 secondary outcomes
Degree of perineal healing using the REEDA scale
Time frame: 2 days
Perineal pain intensity according to NRS scale two days after treatment initiation
Time frame: 2 days (if still in hospital)
Rate of women with improvement in hemorrhoids characteristics in women with hemorrhoids
Time frame: 2 days
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 9 Sep 2026.
- Individual participant dataSharing planned: Undecided
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 Phase 4 study testing Magnesium sulfate 33% solution and Cold water in people with Women After Delivery With Perineal Pain, run by The Baruch Padeh Medical Center, Poriya at 1 site in Israel.
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 2 inclusion and 6 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 9 Sep 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 Israel. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Rate of women with perineal pain score< 3 NRS at the day after treatment initiation (time frame: 24 hours post enrollment). 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 9 Sep 2026; AzTrials last refreshed its copy on 31 Oct 2026.