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Evaluation of the Efficacy of Rectal or Sub-linguinal Misoprostol concomitant with Oxytocin for Prevention of Postpartum Hemorrhage in women with preeclampsia

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History
# Registration date Revision Id
2 2022-05-19, 1401/02/29 227169
1 2020-11-05, 1399/08/15 157577
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  • General information

    126
    128
    empty
    Only 126 patients were changed to 128 patients.
    empty
    فقط تعداد 126 بیمار به 128 بیمار تغییر یافت.
    Pocket shuffling, In this study for a total sample size of 126, the principle investigator write number 1 on 42 blanck cards, number 2 on 42 blanck cards, number 3 on 42 blanck cards. Then, she place them in non-transparent pockets, then give all of them to another person that will shuffle them and put them in a box and give the box back to PI. For every patients included in the study, the PI picks up one card and assign the patient to one of the 3 groups based on the information on that card. The rest of the cards is then shuffled again and placed in a box to be used by another patient. This continues until the last patient.
    Pocket shuffling, In this study for a total sample size of 128, the principle investigator write number 1 on 43 blanck cards, number 2 on 43 blanck cards, number 3 on 43 blanck cards. Then, she place them in non-transparent pockets, then give all of them to another person that will shuffle them and put them in a box and give the box back to PI. For every patients included in the study, the PI picks up one card and assign the patient to one of the 3 groups based on the information on that card. The rest of the cards is then shuffled again and placed in a box to be used by another patient. This continues until the last patient.
    به هم ریختن پاکت ها، در این مطالعه با توجه به حجم نمونه کل 126، محقق اصلی روی 42 کارت سفید شماره گروه 1، روی 42 کارت سفید شماره گروه 2، و روی 42 کارت سفید شماره گروه 3 را می نویسد. سپس این کارت ها را درون پاکت های تیره رنگ که در نور قابل رویت نباشد قرار داده و کل کارت ها را به شخص دیگری می دهد، شخص دیگر این کارت ها را بر می زند و مجددا در اختیار محقق اصلی قرار می دهد. در نهایت پاکت ها را تحویل محقق اصلی می دهد. محقق اصلی با ورود هر شخص به مطالعه یک کارت مهر و موم شده را تصادفا برداشته و آن را باز می کند و بر اساس اطلاعات داخل آن بیمار را به یک گروه وارد کرده و درمان لازم را تجویز می کند. سپس مابقی کارت ها دوباره با هم مخلوط شده و در جعبه گذاشته می شود تا برای بیمار بعدی مورد استفاده باشد. این کار تا آخرین بیمار ادامه می یابد.
    به هم ریختن پاکت ها، در این مطالعه با توجه به حجم نمونه کل 128، محقق اصلی روی 43 کارت سفید شماره گروه 1، روی 43 کارت سفید شماره گروه 2، و روی 43 کارت سفید شماره گروه 3 را می نویسد. سپس این کارت ها را درون پاکت های تیره رنگ که در نور قابل رویت نباشد قرار داده و کل کارت ها را به شخص دیگری می دهد، شخص دیگر این کارت ها را بر می زند و مجددا در اختیار محقق اصلی قرار می دهد. در نهایت پاکت ها را تحویل محقق اصلی می دهد. محقق اصلی با ورود هر شخص به مطالعه یک کارت مهر و موم شده را تصادفا برداشته و آن را باز می کند و بر اساس اطلاعات داخل آن بیمار را به یک گروه وارد کرده و درمان لازم را تجویز می کند. سپس مابقی کارت ها دوباره با هم مخلوط شده و در جعبه گذاشته می شود تا برای بیمار بعدی مورد استفاده باشد. این کار تا آخرین بیمار ادامه می یابد.

  • Recruitment centers

    #1
    Name of recruitment center - English: Shahid Kamali educational center
    Name of recruitment center - Persian: مرکز آموزشی شهید کمالی
    Full name of responsible person - English: Mansooreh Sadeghi Afkham
    Full name of responsible person - Persian: منصوره صادقی افخم
    Street address - English: خیابان شهید بهشتی - میدان شهداء - خیابان کمالی - مرکز آموزشی درمانی کمالی
    Street address - Persian: Shahid- Kamali educational center, Kamali Ave, Shohad St.
    City - English: Karaj
    City - Persian: کرج
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 3134877179
    Phone: +98 26 3222 3021
    Fax:
    Email: m.sadeh.2003@gmail.com
    Web page address:
    Name of recruitment center - English: Shahid Kamali educational center
    Name of recruitment center - Persian: مرکز آموزشی شهید کمالی
    Full name of responsible person - English: Mansooreh Sadeghi Afkham
    Full name of responsible person - Persian: منصوره صادقی افخم
    Street address - English: Shahid- Kamali educational center, Kamali Ave, Shohad St.
    Street address - Persian: خیابان شهید بهشتی - میدان شهداء - خیابان کمالی - مرکز آموزشی درمانی کمالی
    City - English: Karaj
    City - Persian: کرج
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 3134877179
    Phone: +98 26 3222 3021
    Fax:
    Email: m.sadeh.2003@gmail.com
    Web page address:

Protocol summary

Study aim
Evaluation of the efficacy of prophylactic oral misoprostol in comparison with conventiinal treatment for reducing PPH (post-partum hemorrhage) in pre-clampsia Evaluation of the efficacy of prophylactic rectal misoprostol in comparison with conventiinal treatment for reducing PPH (post-partum hemorrhage) in pre-clampsia Evaluation of the efficacy of prophylactic oral and rectal misoprostol for reducing PPH (post-partum hemorrhage) in pre-clampsia
Design
A randomized clinical trial with 2 intercention and 1 control groups, with parellel groups, double blinded, phase 3 on 126 patients, pockent shuffling was used for randomization.
Settings and conduct
The main researcher patients and data analyzer are blind to the study groups. After randomization with the shuffled pocket method, the patient enters the group at random. After spinal anesthesia with the same protocol and C-section, immediately after the umbilical cord clamp, the first group was injected with 400 micrograms of rectal misoprostol, the second group with 400 micrograms of rectal misoprostol. All groups including the control group only recieve 30 U of Oxytocin according to the national protocol.
Participants/Inclusion and exclusion criteria
Inclusion: Age between 18 to 45 years Pregnant mothers with severe pre-eclampsia Hospitalization for C-section Gestational age over 35 weeks A maximum of 2 previous cesarean sections Complete removal of the placenta after cesarean section Exclusion: Chronic hypertension Placental abnormality Complications or emergent condition during surgery High bleeding risk Indication for hysterectomy or TL
Intervention groups
Oral misoprostol Rectal misoprostol Control
Main outcome variables
Gauzes count for blood loss volume will be performed after the operation, 1 hour, 4 hours after surgery, and hemoglobin and hematocrit will be measured 24 hours after delievery.

General information

Reason for update
Only 126 patients were changed to 128 patients.
Acronym
IRCT registration information
IRCT registration number: IRCT20201022049108N1
Registration date: 2020-11-05, 1399/08/15
Registration timing: prospective

Last update: 2022-05-22, 1401/03/01
Update count: 1
Registration date
2020-11-05, 1399/08/15
Registrant information
Name
Mansoore Sadeghi Afkham
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3222 3021
Email address
kh.niloofar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Efficacy of Rectal or Sub-linguinal Misoprostol concomitant with Oxytocin for Prevention of Postpartum Hemorrhage in women with preeclampsia
Public title
Evaluation of the effects of prophylactic misoprostol with oxytocin for postpartum hemorrhage in women with preeclampsia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
ALL pregnant mothers with severe pre-eclampsia who referred to the Shahi Kamali educational center in the study period Hospitalization for C-section Gestational age over 35 weeks Having a healthy and alive fetus Cephalic fetus A maximum of 2 previous cesarean sections Complete removal of the placenta after cesarean section The age of 18-45 years
Exclusion criteria:
Mothers with coagulation disorders History of maternal blood disorders Chronic hypertension Placental adhesion such as placenta previa and ecrta Placental abruption (overt and covert) Complications or emergency during surgery Eclampsia Mild pre-eclampsia Abnormal placenta History of uterine rupture High bleeding risk Indication for hysterectomy or TL
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 128
Randomization (investigator's opinion)
Randomized
Randomization description
Pocket shuffling, In this study for a total sample size of 128, the principle investigator write number 1 on 43 blanck cards, number 2 on 43 blanck cards, number 3 on 43 blanck cards. Then, she place them in non-transparent pockets, then give all of them to another person that will shuffle them and put them in a box and give the box back to PI. For every patients included in the study, the PI picks up one card and assign the patient to one of the 3 groups based on the information on that card. The rest of the cards is then shuffled again and placed in a box to be used by another patient. This continues until the last patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
First, dark envelopes were prepared for the number of total sample size, the inside of which was not visible in the light, and a paper that the name of groups was written on them were placed in them and placed in the operating room. The surgeon picks up an envelope and gives it to the PI. Based on the information in the envelope, the PI prescribes the medication for the patient. The patients and data analyzer will not know what kind of tratment were prescribed.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
lborz University of Medical Sciences
Street address
Kamali St.
City
Karaj
Province
Alborz
Postal code
3134877179
Approval date
2020-10-10, 1399/07/19
Ethics committee reference number
IR.ABZUMS.REC.1399.186

Health conditions studied

1

Description of health condition studied
severe pre-eclampsia
ICD-10 code
O14.13
ICD-10 code description
Severe pre-eclampsia, third trimester

Primary outcomes

1

Description
Bleeding volume with gauze counting
Timepoint
Immediately, 1 hour, and 4 hours after C-section
Method of measurement
gauze counting

2

Description
Hemoglobin and hematocrit changes
Timepoint
24 hours after C-section
Method of measurement
Blood test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Oral misoprostol manufactured in Aboorehyan pharmacy CO, Iran, give to patients sublingually after C-section it is in combination with conventional treatment that is infusion of 30 IU (3 X ampule 10 IU/mL) of same company.
Category
Treatment - Drugs

2

Description
Control group: Without Intervention: after C-section aconventional treatment that is infusion of 30 IU (3 X ampule 10 IU/mL) of Abooreyhan pharmacy CO. Iran. will give to patients.
Category
N/A

3

Description
Intervention group: rectal misoprostol, Oral misoprostol manufactured in Aboorehyan pharmacy CO, iran, give to patients rectally after C-section it is in combination with conventional treatment that is infusion of 30 IU (3 X ampule 10 IU/mL) of same company.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Kamali educational center
Full name of responsible person
Mansooreh Sadeghi Afkham
Street address
Shahid- Kamali educational center, Kamali Ave, Shohad St.
City
Karaj
Province
Tehran
Postal code
3134877179
Phone
+98 26 3222 3021
Email
m.sadeh.2003@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohammad Noori-Sepehr
Street address
Alborz university of medical sciences, Edari town, North Taleghani Blvd., Taleghani SQ
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3255 8920
Email
research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Mansooreh Sadeghi Afkham
Position
Resident of Obstetricians and Gynecologists
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
خیابان شهید بهشتی - میدان شهداء - خیابان کمالی - مرکز آموزشی درمانی کمالی
City
Karaj
Province
Alborz
Postal code
3134877179
Phone
+98 26 3222 2021
Email
m.sadeh.2003@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mina Ataee
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
خیابان شهید بهشتی - میدان شهداء - خیابان کمالی - مرکز آموزشی درمانی کمالی
City
Karaj
Province
Alborz
Postal code
3134877179
Phone
+98 26 3222 2021
Email
ataee.mina@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mansooreh Sadeghi Afkham
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
خیابان شهید بهشتی - میدان شهداء - خیابان کمالی - مرکز آموزشی درمانی کمالی
City
karaj
Province
Alborz
Postal code
3134877179
Phone
+98 26 3222 2021
Email
m.sadeh.2003@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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Results of the study will be published. The study protocol and statistical analysis will be included in the manuscript
When the data will become available and for how long
One year after finishing the study, data will be published and will be available in databases
To whom data/document is available
After permission form the sponsor, data of the study will be available for academic researchers, physicians and scientific institutes
Under which criteria data/document could be used
Other researchers are permitted to included the results in their systematic reviews and metaanalysis
From where data/document is obtainable
Mina Ataee, Shahid Kamali Hospital, Alborz
What processes are involved for a request to access data/document
After receiving the query, dependent on the requested data, the scientific responsible person of the study will response to the query in coordinate with the sponsor within 2 weeks
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