Comparison of the effect of acupressure and topical magnesium sulfate on cervical edema during labor
Design
Clinical trial with control group with parallel groups, double-blind, randomized, phase 2 on 66 pregnant women.
Settings and conduct
This study will be performed in the maternity ward of Mobini Hospital in Sabzevar. Research units are selected by simple sampling, then randomly will be divided to 3 groups of acupressure, topical magnesium sulfate and control group (routine care).The assistant researcher and the participants are unaware of the type of intervention and the study is double-blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18-35 years old age; full-term pregnancy; singleton pregnancy; multiparous woman; live and healthy fetus; cervical edema in the active phase of labor; low-risk pregnancy
Exclusion criteria: Contraindications for vaginal delivery; obstetric and delivery complications
Intervention groups
This double-blind clinical trial study will be performed on 66 pregnant women in 3 groups of acupressure, magnesium sulfate and control group. In the magnesium sulfate group; 10 cc of 50% magnesium sulfate will be poured topically on the cervix. In the acupressure group, pressure will be applied at point SP6 for 30 minutes. Also, the control group will receive routine care.
Main outcome variables
Improve cervical edema
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161222031519N3
Registration date:2020-10-21, 1399/07/30
Registration timing:prospective
Last update:2020-10-21, 1399/07/30
Update count:0
Registration date
2020-10-21, 1399/07/30
Registrant information
Name
Zahra Zare
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 8301
Email address
zarez@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-04-19, 1400/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of acupressure and topical magnesium sulfate on the improvement of cervical edema in women during labor
Public title
Comparison of the effect of acupressure and topical magnesium sulfate on cervical edema during labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Term pregnancy (37-42 weeks)
Singleton pregnancy
multipar woman
The fetus is alive and well
Pregnancy is low risk
There are not contraindications for vaginal delivery
Be in the active phase of labor
Exclusion criteria:
Vaginal bleeding during labor
Non-reassuring fetal heart rate
Detection of Cephalopelvic disproportion during labor
Non-cooperation of pregnant woman
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, "A, B, C" Words are written on 3 pieces of paper and put inside the envelope. Research units are asked to take a piece of paper. Randomization is done for the first three participants, so the process will be repeated for other subjects. A represents the acupressure group, B represents the magnesium sulfate group and C represents the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
For research blinding, drug and acupressure will be conducted by researcher. Examinations for survey cervical edema will be performed by research assistant, who is unaware of the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Tohidshahr Blvd, Pardis Building, Sabzevar University of Medical Sciences, School of Nursing
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Approval date
2020-10-14, 1399/07/23
Ethics committee reference number
IR.MEDSAB.REC.1399.109
Health conditions studied
1
Description of health condition studied
cervical edema
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Evaluation of cervical edema in vaginal examination
Timepoint
One and two hours after the start of the intervention
Method of measurement
vaginal examination
Secondary outcomes
1
Description
Duration of labor
Timepoint
At the time of delivery
Method of measurement
Timer
Intervention groups
1
Description
First intervention group: In the magnesium sulfate group, 10 cc of 50% magnesium sulfate is poured topically on the cervix through a syringe. The mother is asked not to get out of bed until half an hour after sulfate administration.
Category
Treatment - Drugs
2
Description
Second intervention group: In the acupressure group, pressure is applied at point SP6 for one minute and rested for one minute.The pressure continues with the appropriate force (whitening of half of the nail color) and to the extent that the excitatory reaction of pain, heat, tingling, throbbing and heaviness occurs in the research unit.The intervention is performed each time for one foot. The total intervention time lasts 30 minutes.
Category
Treatment - Other
3
Description
Control group: The control group will receive routine care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Sabzevar Mobini Hospital
Full name of responsible person
zahra zare
Street address
Kashefi St, Mobini Hospital
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4423 8100
Email
zare1984@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr Freshteh Ghorat
Street address
Tohidshahr Blvd, Vice Chancellor for Research, Sabzevar University of Medical Sciences
City
sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8301
Email
vc.Research@medsab.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
zahra zare
Position
Instructor of the midwifery group
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Tohidshahr Boulevard, Sabzevar University of Medical Sciences
City
sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8301
Email
zare1984@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
zahra zare
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Sohadaye hastei boulevard, Sabzevar university of medical Sciences Campus
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8319
Email
zare1984@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
zahra zare
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Sohadaye hastei boulevard, Sabzevar university of medical Sciences Campus
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8101
Email
zare1984@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
It is possible to share all the data while maintaining the principle of not mentioning the names of individuals
When the data will become available and for how long
One year after the publication of the related article
To whom data/document is available
Researchers of university centers
Under which criteria data/document could be used
The data of the present study can be used after obtaining permission and approval from the Vice Chancellor for Research and Technology of Sabzevar University of Medical Sciences
From where data/document is obtainable
Refer to the project manager, zahra zare, with email address: zare1984@yahoo.com. and contact number 051- 44018301
What processes are involved for a request to access data/document
After completing the research and publishing the relevant article, individuals can apply to the Vice Chancellor for Research and Technology of Sabzevar University of Medical Sciences to receive documents and after obtaining permission from this department, send a confirmation from the Vice Chancellor for Research to the project manager Can access documentation.