Determining the effect of low oxytocin dose compared to high oxytocin dose in preventing postpartum hemorrhage
Design
Clinical trial without control group, three-way blind, randomized, phase 1 on 60 patients.
Settings and conduct
The first group will receive an oxytocin dose of 10 units per 500 cc of Ringer serum and the second group will receive 60 units of oxytocin per 500 cc of Ringer serum. We chose 10 units A dose for the intervention group and 60 units B for the intervention group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: primiparous; age 18-45 years old; gestational age 37-41 weeks; singleton pregnancy; cephalic.
Exclusion criteria: history of medical and obstetric diseases; fetal malformations; fetal weight estimate over 4000 g; diagnosis of chorioamnionitis; placental abruption.
Exclusion criteria during the study: first and second stage of long labor; cesarean section; labor dystocia; shoulder dystocia; prenatal bleeding; instrumental labor.
Intervention groups
The first group will receive an oxytocin dose of 10 units per 500 cc of Ringer serum and the second group will receive 60 units of oxytocin per 500 cc of Ringer serum. We chose 10 units A dose for the intervention group and 60 units B for the intervention group.
Main outcome variables
postpartum hemorrhage collected in drape sheet 2 hours after delivery; admission hematocrit and hemoglobin; hematocrit and hemoglobin 2 hours after delivery
General information
Reason for update
Acronym
OXT
IRCT registration information
IRCT registration number:IRCT20220122053780N1
Registration date:2022-01-29, 1400/11/09
Registration timing:registered_while_recruiting
Last update:2022-01-29, 1400/11/09
Update count:0
Registration date
2022-01-29, 1400/11/09
Registrant information
Name
Maryam Zamani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 154 6300
Email address
zamanim1@nums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-25, 1400/10/04
Expected recruitment end date
2022-05-25, 1401/03/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of low dose with high dose of oxytocin in prevention of postpartum hemorrhage
Public title
The comparison of low dose with high dose of oxytocin in prevention of postpartum hemorrhage
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous
Age 18-45 years old
Gestational age 37-41 weeks
Singleton pregnancy
Cephalic presentation
Exclusion criteria:
History of medical and obstetric diseases
Fetal malformations
Fetal weight estimate over 4000 g
Diagnosis of cryoamniosis
Placental abruption
First and second stage of long labor
Cesarean section
Labor dystocia
Shoulder dystocia
Prenatal bleeding
Instrumental labor
Age
From 18 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
30
All pregnant mothers admitted to Hakim Neishabour Hospital for normal delivery
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked Randomization with Randomly Selected Block Sizes will be used for random allocation. Through random 4, 8 and 12 blocks, each participant will be placed in one of the intervention groups. The allocation sequence will be generated using the website https://www.sealedenvelope.com/simple-randomiser/v1/lists and with the help of the methodology consultant. Since all participants are registered in a hospital (center), white envelopes will be used to hide the sequence. In this way, each sequence will be placed in a white envelope and the envelopes will be placed next to each other and the envelopes will be numbered. An envelope will be opened for each person in the order of their entry into the study and will be assigned to the groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
To blind the study (three-blind); The researcher, outcome evaluator (assistant researcher), participant and statistical analyst will not know the dose of oxytocin in serums.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Neyshabur University of Medical Sciences
Street address
Farhangian Ave., Neyshabur city
City
Neyshaur
Province
Razavi Khorasan
Postal code
93186-14139
Approval date
2021-12-25, 1400/10/04
Ethics committee reference number
IR.NUMS.REC.1400.036
Health conditions studied
1
Description of health condition studied
Postpartum hemorrhage
ICD-10 code
O72
ICD-10 code description
Postpartum hemorrhage
Primary outcomes
1
Description
Postpartum hemorrhage amount
Timepoint
Immediately after delivery and each quarter to 2 hours after delivery
Method of measurement
Using measured Drape sheets for blood collection (disposable, funnelled, plastic collector bag) and reporting to cc
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Receiving10 unit Oxytocin in 500 cc Ringer serum
Category
Prevention
2
Description
Intervention group: Receiving 60 unit Oxytocin in 500 cc Ringer serum
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hakim Hospital
Full name of responsible person
Maryam Zamani
Street address
Farhangian Ave., Neyshabur
City
Neyshabur
Province
Razavi Khorasan
Postal code
93186-14139
Phone
+98 915 154 6300
Email
zamanim1@nums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Dr. Ali Akbar Mohammadi
Street address
Farhangian Ave., Neyshabur
City
Neyshabur
Province
Razavi Khorasan
Postal code
93186-14139
Phone
+98 51 4330 6219
Email
researchnums1@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Neyshabour 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
Neyshabour University of Medical Sciences
Full name of responsible person
Maryam Zamani
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Medical Sciences Campus, Moqavmat Boulevard, Baghcheban
City
Neyshabur
Province
Razavi Khorasan
Postal code
93186-14139
Phone
+98 915 154 6300
Email
zamanim1@nums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Maryam Zamani
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Medical Sciences Campus, Moqavmat Boulevard, Baghcheban
City
Neyshabur
Province
Razavi Khorasan
Postal code
93186-14139
Phone
+98 915 154 6300
Email
zamanim1@nums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Maryam Zamani
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Medical Sciences Campus, Moqavmat Boulevard, Baghcheban
City
Neyshabur
Province
Razavi Khorasan
Postal code
93186-14139
Phone
+98 915 154 6300
Email
zamanim1@nums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentifiable individuals.
When the data will become available and for how long
Start from 2021
To whom data/document is available
There is no restriction.
Under which criteria data/document could be used
There is no restriction.
From where data/document is obtainable
Maryam Zamani
Zamanim1@nums.ac.ir
00989151546300
What processes are involved for a request to access data/document