Cold Magnesium Sulfate Solution for Perineal Swelling Fol... | NCT02024256

Studies
Cold Magnesium Sulfate Solution for Perineal Swelling Following Vaginal Delivery

NCT02024256

Sponsor

HaEmek Medical Center, Israel

Status

Unknown status

Last Update Posted

Sep 30, 2016Estimated

Enrollment

206Estimated

Phase

Not Applicable

Conditions

Vaginal Delivery
Perineal Swelling
Perineal Pain

Interventions

Cold pads soaked in Magnesium sulfate solution
Cold pads soaked in water

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Jan 2018Estimated

Completion Date

Not provided

First Submitted Date

Dec 25, 2013

First Submission Date that Met QC Criteria

Dec 30, 2013

First Posted Date

Dec 31, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2016

Last Update Posted Date

Sep 30, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

206Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Magnesium sulfate	Active Comparator	Pads soaked in cold magnesium sulfate solution	Other: Cold pads soaked in Magnesium sulfate solution
Water	Sham Comparator	Pads soaked with cold water	Other: Cold pads soaked in water

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cold pads soaked in Magnesium sulfate solution	Other		Magnesium sulfate	Epson salt, MgSo4

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction in the level of perineal pain		3 days
Reduction in perineal swelling		3 days

Secondary Outcomes

Measure	Description	Time Frame
Reduction in hemorrhoids pain and swelling		3 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zohar Nahum, MD	Contact	97246494158		nachum_zo@clalit.org.il
Irit Friedman, MA	Contact	972546202261		iritdavid@gmail.com, irit_da@clalit.org.il

Overall Officials

Name	Affiliation	Role
Zohar Nahum, MD	HaEmek medical center affiliated to Rappaport faculty of medicine, Technion, Haifa, Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
HeEmek medical center	Recruiting	Afula		18101	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33034900	Derived	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.

ID	Term
D006878	Hydroxides
D000468	Alkalies
D007287	Inorganic Chemicals
D000838	Anions
D007477