Cold Magnesium Sulfate Solution for Perineal Swelling Following Vaginal Delivery
NCT ID: NCT02024256
Last Updated: 2016-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
206 participants
INTERVENTIONAL
2014-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison Between Pads With Cold Solution of Magnesium Sulfate or Cold Water Postpartum Perineal Pain and Healing
NCT04464005
Epsom Salt Compresses to Relieve Perineal for Postpartum Care: a Clinical Trial
NCT06393608
Magnesium Sulfate vs Placebo for Placental Abruption
NCT00186069
A Device Designed to Protect the Perineum During Labor
NCT01533467
Magnesium Sulfate Versus Indomethacin for Preterm Labor
NCT00116623
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Magnesium sulfate
Pads soaked in cold magnesium sulfate solution
Cold pads soaked in Magnesium sulfate solution
Water
Pads soaked with cold water
Cold pads soaked in water
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cold pads soaked in Magnesium sulfate solution
Cold pads soaked in water
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* reporting of perineal pain equal to or greater than 3 on a 0-10 scale
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
HaEmek Medical Center, Israel
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zohar Nahum, MD
Role: PRINCIPAL_INVESTIGATOR
HaEmek medical center affiliated to Rappaport faculty of medicine, Technion, Haifa, Israel
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
HeEmek medical center
Afula, , Israel
HaEmek medical center
Afula, , Israel
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MG33
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.