Comparison of postpartum hemorrhage in three groups receiving oxytocin, sublingual misoprostol and intrauterine misoprostol
Design
Clinical trial without control group, with parallel groups, double-blind, randomized, phase 2 on 237 patients. Excel software rand function was used for randomization.
Settings and conduct
Sequences of the intervention groups will be provided for the operating room in matte envelopes, and When the cesarean section is started, it will be opened by the nurse cooperating in the study. All participants and surgeons will be unaware of the grouping of the participants before the time of the intervention. Intervention will be applied in the operating room after placental abruption to all three groups
Participants/Inclusion and exclusion criteria
Pregnant women between the ages of 18 and 40 with a term pregnancy will be included in the study if they have a history of cesarean section and will be excluded from the study if they have coagulation problems and multiple pregnancies.
Intervention groups
Intervention group 1: Oxytocin 10 units (inside 500 cc of Ringer serum) and sublingual misoprostol tablets of 400 micrograms (after placental abruption and uterine correction are inserted in the patient's sublingual and controlled by anesthesia technician to prevent suffocation)
Intervention group 2: Oxytocin recipient 10 units (inside 500 cc of Ringer serum) and intrauterine misoprostol tablet of 400 micrograms (after placental abruption and uterine correction, it is inserted in two uterine poles - 200 micrograms in each cornea)
Intervention group 3: Oxytocin receptor 30 units (within 500 cc of Ringer serum)
Main outcome variables
Bleeding volume during cesarean section and within 24 hours after surgery; Drug side effects and duration of surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100429003833N2
Registration date:2021-10-02, 1400/07/10
Registration timing:registered_while_recruiting
Last update:2021-10-02, 1400/07/10
Update count:1
Registration date
2021-10-02, 1400/07/10
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
3373741
Email address
rahmaniv@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-06-02, 1401/03/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of misoprostol and oxytocine on postpartum Hemorrhage
Public title
Comparison of the effects of misoprostol and oxytocine on postpartum Hemorrhage
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
singleton pregnant women
elective cesarean delivery
Maximum history of once cesarean section
Exclusion criteria:
Preeclampsia
Cardiovascular diseases
Uterine myoma
A history of excessive bleeding after delivery.
Underlying disease, such as coagulopathy
Abnormal placental implantation (Placenta peria or Ecrta)
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
237
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients will be divided into three groups using a table of random numbers. This table contains the numbers 1 to 237 irregularly and without a specific pattern. To prepare this table, the site https://www.Randomization.com will be used. Numbers will be read by default (up, down, left or right). Then, the numbers 0-90 will be considered for group A, the numbers 91-181 for group B and the numbers 182-273 for group C. For concealment, opaque and sealed envelopes will be used. Each number will be written on a card and the cards will be placed inside the envelopes. When a patient enters the study, one of the envelopes is opened and the assigned group of that patient is revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
Sequences of the intervention groups will be provided for the operating room in matte envelopes, and When the cesarean section is started, it will be opened by the nurse cooperating in the study. Each group will be treated according to a specific treatment protocol. All participants and surgeons will be unaware of the grouping of the participants before the time of the intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Tabriz University Of Medical Sciences
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2021-08-02, 1400/05/11
Ethics committee reference number
IR.TBZMED.REC.1400.409
Health conditions studied
1
Description of health condition studied
Postpartum hemorrhage
ICD-10 code
072.1
ICD-10 code description
Other immediate postpartum haemorrhage
Primary outcomes
1
Description
Bleeding volume during cesarean section
Timepoint
After the placenta is removed until the uterus is repaired
Method of measurement
Number of gases and lumps of wet gases and volume of blood in suction
2
Description
Bleeding volume during the first 24 hours of cesarean section
Timepoint
Hemoglobin and hematocrit are measured 24 hours after surgery and compared with preoperative values.
Method of measurement
blood test
3
Description
Duration of surgery
Timepoint
From the start of surgery to complete repair of the uterus
Method of measurement
Record start and end times
Secondary outcomes
1
Description
Drug side effects
Timepoint
From the time of hospitalization to the patient's discharge
Method of measurement
Control vital signs
Intervention groups
1
Description
Intervention group 1: Oxytocin 10 units (inside 500 cc of Ringer's serum) and sublingual misoprostol tablets of 400 micrograms (after placental abruption and uterine correction are inserted in the patient's sublingual and controlled by anesthesia technician to prevent suffocation.)
Category
Treatment - Drugs
2
Description
Intervention group 2: Oxytocin recipient 10 units (inside 500 cc of Ringer serum) and intrauterine misoprostol tablet of 400 micrograms (after placental abruption and uterine correction, it is inserted in two uterine poles - 200 micrograms in each cornea)
Category
Treatment - Drugs
3
Description
Intervention group 3: Oxytocin receptor 30 units (within 500 cc of Ringer serum)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Vahideh Rahmani
Street address
Alzahra Hospital, South Artesh St.,Tabriz, iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research,Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Mohammad Samiei
Street address
No. 2 Central Building, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3335 7310
Email
lahroudin@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research,Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Vahideh Rahmani
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 35519161
Email
lahroudin@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Vahideh Rahmani
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
004135539161
Email
lahroudin@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Vahideh Rahmani
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 35519161
Email
lahroudin@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