Vaginal DeliveryMgSo4NCT02024256
Cold Magnesium Sulfate Solution for Perineal Swelling Following Vaginal Delivery
A study testing Cold pads soaked in Magnesium sulfate solution and Cold pads soaked in water in people with Vaginal Delivery and Perineal Swelling, run by HaEmek Medical Center, Israel at 2 sites in Israel.
Trial summary
The purpose of this study is to compare the impact of treatment with cooled magnesium sulfate and cold water-soaked pads on perineal pain and swelling following vaginal delivery. Assessment of appropriateness for each patient to take part in the study will be performed approximately 2 hours following delivery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginal Delivery, Perineal Swelling, Perineal Pain
- What is being tested?
- Cold pads soaked in Magnesium sulfate solution and Cold pads soaked in water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 2 sitesIsrael
- Study dates
- Jan 2014to Jan 2018
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- parturients following normal vaginal birth or vacuum-assisted vaginal delivery
- reporting of perineal pain equal to or greater than 3 on a 0-10 scale
Who cannot join
- parturients following cesarean section
- lack of consent to take part in the study
- parturients interested in early discharge (within 48 hours of childbirth)
- girls under 18 years of age
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
HeEmek medical center
Afula, 18101
Zohar Nahum, md, 97241584649, nachum_zo@clalit.org.il
Irit Friedman, 972546202261, iritdavid@gmail.com, irit_da@clalit.org.il
- Recruiting
HaEmek medical center
Afula
Nahum Zohar, MD
About this study
Official title: Comparison Between Treatment With Gauze Soaked With Cold Magnesium Sulfate Solution Against Gauze Soaked With Cold Water for Treatment of Perineal Swelling Following Vaginal Delivery - A Double Blind Placebo Controlled Trial
The purpose of this study is to compare the impact of treatment with cooled magnesium sulfate and cold water-soaked pads on perineal pain and swelling following vaginal delivery.
Assessment of appropriateness for each patient to take part in the study will be performed approximately 2 hours following delivery. Those patients who consent to participate in the trial will be allocated to treatment groups in a double-blinded, randomized manner. Women in the study group will receive treatment with pads soaked in a cold aqueous solution of magnesium sulfate at 33% (w/v) concentration, while those in the control group will receive treatment with pads soaked in cold water.
Read more
Nurses will initiate treatment according to the group to which the patient was randomized. Said pads will be given the patients routinely 5 times a day at regular times.
A physician will assess the perineal swelling according to visual (photographed) scale in which severe, moderate, light and no swelling will be defined. Measurement of swelling in centimeters (maximal length and breadth); photography, by a medical photographer or the examining doctor, of the perineal area with a centimeter ruler, before, during and after treatment (photography is dependent on patient approval and is not a precondition to participation in the trial.); and additional examination, on the above basis, will be performed regarding hemorrhoids in the event that a patient has complained of such.
A nurse will assess the perineal pain and swelling on a scale ranging from 0 to 10 prior to the patient being given the pad and an hour following treatment. An additional assessment by the same method will be performed regarding hemorrhoid pain. Any analgesia administered will also be recorded.
Likewise, for follow-up purposes a blood test for serum magnesium concentration will be taken before and after treatment.
Period of follow-up will be 48-72 hours from childbirth.
- Conditions
- Vaginal Delivery, Perineal Swelling, Perineal Pain
- Being tested
- Cold pads soaked in Magnesium sulfate solution, Cold pads soaked in water
- Keywords
- Vaginal delivery, Perineal swelling, Perineal pain, MgSo4, Magnesium sulfate, Cold water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold pads soaked in Magnesium sulfate solutionOther
Also called Epson salt, MgSo4
Cold pads soaked in waterOther
| Study group | Role | What they receive |
|---|---|---|
| Magnesium sulfate | Active comparator | Pads soaked in cold magnesium sulfate solution Receives: Other: Cold pads soaked in Magnesium sulfate solution |
| Water | Sham comparator | Pads soaked with cold water Receives: Other: Cold pads soaked in water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the level of perineal pain
Measured: 3 days
Reduction in perineal swelling
Measured: 3 days
Secondary outcomes (1)
Reduction in hemorrhoids pain and swelling
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaginal DeliveryStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zohar Nahum, MD, Principal investigator, HaEmek medical center affiliated to Rappaport faculty of medicine, Technion, Haifa, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024256
- Sponsor's protocol ID
- MG33
- Acronym
- MgSo4
- Status last verified
- Sep 2016
- First submitted
- 25 Dec 2013
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
East CE, Dorward ED, Whale RE, Liu J. Local cooling for relieving pain from perineal trauma sustained during childbirth. Cochrane Database Syst Rev. 2020 Oct 9;10(10):CD006304. doi: 10.1002/14651858.CD006304.pub4.
PubMed 33034900
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Treatment With Gauze Soaked With Cold Magnesium Sulfate Solution Against Gauze Soaked With Cold Water for Treatment of Perineal Swelling Following Vaginal Delivery - A Double Blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT02024256
- Acronym / sponsor ID
- MgSo4 / MG33
- Conditions
- Vaginal Delivery, Perineal Swelling, Perineal Pain
- Keywords
- Vaginal delivery, Perineal swelling, Perineal pain, MgSo4, Magnesium sulfate, Cold water
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2018 (estimated)
- First posted
- 31 Dec 2013 (estimated)
- 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 purpose of this study is to compare the impact of treatment with cooled magnesium sulfate and cold water-soaked pads on perineal pain and swelling following vaginal delivery.
Assessment of appropriateness for each patient to take part in the study will be performed approximately 2 hours following delivery. Those patients who consent to participate in the trial will be allocated to treatment groups in a double-blinded, randomized manner. Women in the study group will receive treatment with pads soaked in a cold aqueous solution of magnesium sulfate at 33% (w/v) concentration, while those in the control group will receive treatment with pads soaked in cold water.
Nurses will initiate treatment according to the group to which the patient was randomized. Said pads will be given the patients routinely 5 times a day at regular times.
A physician will assess the perineal swelling according to visual (photographed) scale in which severe, moderate, light and no swelling will be defined. Measurement of swelling in centimeters (maximal length and breadth); photography, by a medical photographer or the examining doctor, of the perineal area with a centimeter ruler, before, during and after treatment (photography is dependent on patient approval and is not a precondition to participation in the trial.); and additional examination, on the above basis, will be performed regarding hemorrhoids in the event that a patient has complained of such.
A nurse will assess the perineal pain and swelling on a scale ranging from 0 to 10 prior to the patient being given the pad and an hour following treatment. An additional assessment by the same method will be performed regarding hemorrhoid pain. Any analgesia administered will also be recorded.
Likewise, for follow-up purposes a blood test for serum magnesium concentration will be taken before and after treatment.
Period of follow-up will be 48-72 hours from childbirth.
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 |
|---|---|---|
| Magnesium sulfate | Active comparator | Other: Cold pads soaked in Magnesium sulfate solutionPads soaked in cold magnesium sulfate solution |
| Water | Sham comparator | Other: Cold pads soaked in waterPads soaked with 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)
- parturients following normal vaginal birth or vacuum-assisted vaginal delivery
- reporting of perineal pain equal to or greater than 3 on a 0-10 scale
Key exclusion criteria (4 listed)
- parturients following cesarean section
- lack of consent to take part in the study
- parturients interested in early discharge (within 48 hours of childbirth)
- girls under 18 years of age
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 |
|---|---|---|
| Cold pads soaked in Magnesium sulfate solutionAlso: Epson salt, MgSo4 | Other | Magnesium sulfate |
| Cold pads soaked in water | Other | Water |
Primary outcome
Reduction in the level of perineal pain
Time frame: 3 days
Reduction in perineal swelling
Time frame: 3 days
1 secondary outcome
Reduction in hemorrhoids pain and swelling
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
- Derived from this study: PubMed 33034900East CE, Dorward ED, Whale RE, Liu J. Local cooling for relieving pain from perineal trauma sustained during childbirth. Cochrane Database Syst Rev. 2020 Oct 9;10(10):CD006304. doi: 10.1002/14651858.CD006304.pub4.
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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.
Zohar Nahum, MD principal investigator
HaEmek medical center affiliated to Rappaport faculty of medicine, Technion, Haifa, Israel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold pads soaked in Magnesium sulfate solution and Cold pads soaked in water in people with Vaginal Delivery and Perineal Swelling, run by HaEmek Medical Center, Israel at 2 sites 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 4 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: status not confirmed, as of the sponsor's last update on 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zohar Nahum, MD (97246494158, nachum_zo@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in the level of perineal pain (time frame: 3 days). 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?
On the ClinicalTrials.gov record for NCT02024256, which also lists 1 linked publication.
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 30 Sep 2016.