Effect of Intravenous Magnesium Sulfate and Sublingual Nitroglycerin Spray on Increased Uterine Activity in Labor in Pregnant Women Referred to Mahdie Hospital
Design
Pregnant women who undergo more than 5 contraction per minute for 10 minutes after the second phase of delivery after misoprostol or oxytocin or follow-up spontaneous pain after initial resuscitation measures one group of candidates receiving magnesium sulfate for 4 grams intravenous infusion within ten minutes and the other group receiving sublingual nitroglycerin spray puffs were repeated. After ten minutes the therapeutic response is evaluated and compared in terms of the number of contractions and the fetal heart rate. Standard treatment will be given to patients if they do not correct the fetal heart rate drop following these two medications
Settings and conduct
The study was performed at Mahdieh Hospital in Tehran.Patients entered the screening stage after receiving the necessary information about the trial and drug side effects, and if they wished to enter the study. Pregnant women who experienced more than five contractions in ten minutes after using misoprostol or oxytocin or following spontaneous pain before the second stage of labor.The study was conducted randomly and the participants entered the study only according to the necessary conditions in the entry criteria section
Participants/Inclusion and exclusion criteria
Entry requirements:Mothers who have had increased uterine contractility during labor.
No entry conditions: Use any other medication to reduce contractions such as pethidine
Intervention groups
Intervention group 1: Magnesium sulfate 4 g intravenous infusion within ten minutes
Intervention group II: receive a sublingual nitroglycerin spray puff
Main outcome variables
Magnesium Sulfate; Age of Pregnancy; Nitroglycerin Spray ; Extra Uterine Contractions ; Heart Rate Deficit; Emergency Cesarean
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191106045347N1
Registration date:2020-06-30, 1399/04/10
Registration timing:retrospective
Last update:2020-06-30, 1399/04/10
Update count:0
Registration date
2020-06-30, 1399/04/10
Registrant information
Name
Maryam Azad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 0980
Email address
azad@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-04, 1399/02/15
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized comparison of intravenous magnesium sulfate VS subligual nitroglycerin spray on Uterine hypercontractility during labor in Mahdieh-hospital
Public title
Randomized comparison of intravenous magnesium sulfate VS subligual nitroglycerin spray on Uterine hypercontractility during labor in Mahdieh-hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy women without underlying disease
Single pregnancy pregnancy
A healthy fetus with a normal heart rate
Pregnancy over 37 weeks (semester and post semester)
Spontaneous labor pain or induced by misoprostol or oxytocin
Exclusion criteria:
Contraindications to MgSo4 include Myasthenia Gravis, advanced muscle weakness, a history of allergy to MgSo4, severe renal impairment, and heart block.
Restricted fetal growth, abnormalities and known fetal anomalies
Fetal distress
Chorioamnionitis
placenta previa,placenta acaeta-increta-precreta
Multiple pregnancies
Patient dissatisfaction
Polyhydramnios
Previous cesarean section
Oct positive test
Take any medication other than multivitamins, multivitamins and iron
Pregnant women with underlying diseases such as diabetes, high blood pressure, heart disease and so on
Nitroglycerin contraindications
Acute circulatory failure such as shock collapse system circulatory system
Clear hypotension in systolic blood pressure less than 90
Severe anemia (hemoglobin less than 7)
Age
From 18 years old to 50 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly assigned (Using random table of numbers) to be divided into two groups. One group of candidates received magnesium sulfate at 4 g intravenous infusion within ten minutes, and the other candidate received a subcutaneous spray of nitroglycerin spray. The even numbers will belong to the first group and the odd numbers will belong to the second group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19839-63113
Approval date
2019-06-24, 1398/04/03
Ethics committee reference number
IR.SBMU.MSP.REC.1398.300
Health conditions studied
1
Description of health condition studied
increased uterine activity during childbirth
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
uterine activity during delivery
Timepoint
During delivery
Method of measurement
In the second stage of labor, the number of contractions will be recorded in ten minutes
Secondary outcomes
1
Description
number of uterine contractions
Timepoint
During excessive uterine activity during induction of labor
Method of measurement
More than 5 contraction within 10 minutes during induction of labor
Intervention groups
1
Description
Intervention group 1: Receiving magnesium sulfate in the amount of 4 g intravenous infusion within ten minutes.
Category
Treatment - Drugs
2
Description
Intervention group 2: Get a sublingual spray nitroglycerin spray puff.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdieh Hospital
Full name of responsible person
Maryam Azad
Street address
Shoush Square, Fadaiyan Eslam St , Glass House Alley , Shahid Rajab Nia St
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
mahdiyeh_hospital@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak,
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
tayebeh.jahed@yahoo.com
Grant name
.
Grant code / Reference number
.
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Azad
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 8, Unit 6, West Golestan St., 22 Eskandar St., East Prophet, Ashrafi Isfahani Intersection
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
Azad@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Azad
Position
MD
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 8, Unit 6, West Golestan St., 22 Eskandar St., East Prophet, Ashrafi Isfahani Intersection
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
Azad@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Azad
Position
MD
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 8, Unit 6, West Golestan St., 22 Eskandar St., East Prophet, Ashrafi Isfahani Intersection
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
Azad@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD