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Comparison of the effect of sublingual mesoprostol, rectal and venous oxytocin on cesarean uterine bleeding

Protocol summary

Study aim
Comparison of the effect of sublingual mesoprostol, rectal and venous oxytocin on cesarean uterine bleeding
Design
Clinical trial with control group, with parallel groups, single blind, simple random,Randomization through block randomization, on 180 patients.
Settings and conduct
This study will be performed on a single blind in the operating room of Shahid Sayad Shirazi Hospital in Gorgan on pregnant mothers who are candidates for cesarean section. The sampling method is random and through block randomization, the samples are divided into 3 groups of 60 people. We divide: (groups A, B and C) 1) Group A: Sublingual mesoprostol tablets + intravenous oxytocin 2) Group B: Rectal misoprostol tablets + intravenous oxytocin 3) Group C = or control : Intravenous oxytocin
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients between the ages of 18 and 40, cesarean section candidate, gestational age between 37 and 40 weeks, Spinal anesthesia candidate, patient consent, single pregnancy and low transverse uterine incision. Exclusion criteria: history of PPH (postpartum hemorrhage), placenta proia and acarta, liver or kidney disease, eclampsia and preeclampsia, epilepsy, height below 155 cm, obesity (BMI> 40) ( BMI = Body mass index), infant weight over 4 kg, polyhydramnios (increase) Amniotic fluid), patients receiving anticoagulants, patients with heart and lung problems and underlying diseases such as diabetes, hypertension (hypertension above 140/90 mm Hg), chronic anemia, coagulation disorders and immunodeficiency.
Intervention groups
Samples will be divided into three groups, A, B and C. 1) Group A: Sublingual mesoprostol tablets + intravenous oxytocin 2) Group B: Rectal misoprostol tablets + intravenous oxytocin 3) Group C = or control : Intravenous oxytocin
Main outcome variables
Bleeding during cesarean section

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200501047257N1
Registration date: 2020-05-18, 1399/02/29
Registration timing: registered_while_recruiting

Last update: 2020-05-18, 1399/02/29
Update count: 0
Registration date
2020-05-18, 1399/02/29
Registrant information
Name
Fatemeh Zahra Bagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3223 3381
Email address
bagheri.z1994@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-10, 1399/02/21
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of sublingual mesoprostol, rectal and venous oxytocin on cesarean uterine bleeding
Public title
Evaluation of the effect of misoprostol on cesarean bleeding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between the ages of 18 and 40 Candidates for cesarean section Gestational age between 37 and 40 weeks Candidates for Spinal anesthesia Written consent from the patient Single pregnancy Low transverse uterine incision
Exclusion criteria:
History of PPH (postpartum hemorrhage) Placenta previa and acarta Liver or kidney disease Eclampsia and preeclampsia Epilepsy Height below 155 cm Obesity (BMI> 40) ( BMI = Body mass index) Infant weight over 4 kg Polyhydramnios (increased amniotic fluid) Patients received Anti-coagulation drugs Patients with heart and lung problems and underlying diseases such as diabetes, high blood pressure (140/90 mm Hg), chronic anemia, coagulation disorders and immunodeficiency
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 180
Randomization (investigator's opinion)
Randomized
Randomization description
To allocate groups via permutation block randomization will be used, patients in the study using the blocks 6 each using the letters A, B, and C (for equality groups), the patients into 3 groups of 6 people divided . For permutation block randomization method of sealed envelopes with random sequences will be used.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, blindness is performed for statistical counselors as statistical counselors are not aware of the type of data they perform for analysis and only the data are identified by three groups A, B and C, and they are named by groups. And the method of intervention is unknown.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Sari, Farahabad Road, Mazandaran University of Medical Sciences, School of Paramedical Sciences
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2020-04-29, 1399/02/10
Ethics committee reference number
IR.MAZUMS.REC.1399.134

Health conditions studied

1

Description of health condition studied
The amount of bleeding from a cesarean section
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Bleeding during cesarean section
Timepoint
Bleeding is removed during surgery and after surgery
Method of measurement
The amount of blood lost in each group at the end of the operation, based on the amount of blood in the suction and the estimated blood volume absorbed by each gauze and long gauze with the scales before and after The operation is weighed and the amount of clot excreted from the vagina after uterine massage is calculated at the end of the operation and will be recorded in the desired checklist.

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: After umbilical cord clamping during surgery, the patient will receive 20 oxytocin units within half a liter of Ringer's serum at a rate of 15 cc per minute.In the first intervention group, we place 200 micrograms of misoprostol in the patient's sublingual (It should be noted that Mizoprostol 100 mg tablets are from Abu Reihan Company and 10 units of Oxytocin ampoules are from Alborz Daroo Company).  If proper uterine contraction does not occur after a few minutes (maximum 5 minutes), if the initial intervention is not enough, oxytocin will be repeated up to 100 units (inside the Ringer's serum) and if we need more medication, misoprostol. We continue up to 1000 micrograms
Category
Treatment - Surgery

2

Description
Second intervention group: After umbilical cord clamping during surgery, the patient will receive 20 oxytocin units within half a liter of Ringer's serum at a rate of 15 cc per minute.In the second intervention group, we place 200 micrograms of misoprostol in the patient's rectal area (It should be noted that Mizoprostol 100 mg tablets are from Abu Reihan Company and 10 units of Oxytocin ampoules are from Alborz Daroo Company). If proper uterine contraction does not occur after a few minutes (maximum 5 minutes), if the initial intervention is not enough, oxytocin will be repeated up to 100 units (inside the Ringer's serum) and if we need more medication, misoprostol. We continue up to 1000 micrograms
Category
Treatment - Surgery

3

Description
Control group: After umbilical cord clamping during surgery, the patient will receive 20 oxytocin units within half a liter of Ringer's serum at a rate of 15 cc per minute(It should be noted that the oxytocin ampoule is 10 units from Alborz Daroo Co.) . If proper uterine contraction does not occur after a few minutes (maximum 5 minutes), oxytocin is repeated for up to 100 units (inside the Ringer's serum).
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sayad Shirazi Hospital
Full name of responsible person
Mahboobeh Azadeh Rah
Street address
Shahid Sayad Shirazi Blvd., Shahid Sayad Shirazi Hospital
City
Gorgan
Province
Golestan
Postal code
4917867439
Phone
+98 17 3220 2291
Email
dr.azadehrah@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Majid Saeedi
Street address
Sari, Imam Square, Joibar Three Ways, at the beginning of Valiasr Highway, Central Headquarters of Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4000
Email
magsaeedi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Fatemeh Zahra Bagheri
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Surgical technology
Street address
Gorgan Jadid First Street, 1st Alley, in front of Rosta Complex, two-storey private house
City
Gorgan
Province
Golestan
Postal code
4913714861
Phone
+98 17 3223 3381
Email
bagheri.z1994@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hooshang Akbari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sari, Imam Square, Joibar Three Ways, at the beginning of Valiasr Highway, Central Headquarters of Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4000
Email
hooshangakbari48@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fatemeh Zahra Bagheri
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
Gorgan Jadid First Street, 1st Alley, in front of Rosta Complex, two-storey private house
City
Gorgan
Province
Golestan
Postal code
4913714861
Phone
+98 17 3223 3381
Email
bagheri.z1994@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Not applicable
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
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