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The effect of mummy on postpartum hemorrhage in Afghan multiparous women

Protocol summary

Study aim
Investigating the effect of mummy medicine on postpartum bleeding
Design
After convenience sampling, the samples are placed in two groups using random allocation by the software. After the removal of the placenta and fetal membranes, the researcher will put the first dose of mummy rectal suppository (intervention group) and placebo (control group) and the next dose with an interval of 2 hours. Bleeding rate during the third stage of labor and the first 4 hours after delivery were measured.
Settings and conduct
A two-group, three-blind, randomized clinical trial (intervention, placebo) on Afghan women referred to Hazrat Umm al-Binin (pbuh) and Shahid Hasheminejad hospitals in Mashhad.
Participants/Inclusion and exclusion criteria
Afghan women aged 18-45 living in Mashhad, number of births less than 5, normal delivery, single baby and full-term, healthy, hospitalized in the active phase of labor, hemoglobin above 8, not having a history of mental illness, Not using specific chemical or herbal medicines, no addiction to drugs, no history of uterine surgery or caesarean, no use of drug analgesia to reduce labor pain, no severe bleeding in postpartum, no history of allergy to mummy according to the mother of self-report/ Exclusion criteria: the mother's unwillingness to continue the research, the mother's refusal to take the second dose of the drug or placebo, the occurrence of complications that disrupt the routine care.
Intervention groups
After the removal of the placenta and fetal membranes, the researcher will place the first dose of mummy rectal suppository or placebo and the next dose with an interval of 2 hours. Bleeding rate using droshit blood collection bag and hygienic pad during the third stage of labor and the first 4 hours after delivery were measured. The result will be recorded in the bleeding information form.
Main outcome variables
postpartum hemorrhage in women

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240318061331N1
Registration date: 2024-03-31, 1403/01/12
Registration timing: prospective

Last update: 2024-03-31, 1403/01/12
Update count: 0
Registration date
2024-03-31, 1403/01/12
Registrant information
Name
Hamideh Yazdimoghaddam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4465 4082
Email address
ha_yazdimoghaddam@yahoo.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-04-17, 1403/01/29
Expected recruitment end date
2026-01-17, 1404/10/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mummy on postpartum hemorrhage in Afghan multiparous women
Public title
The effect of mummy on postpartum hemorrhage in women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Afghan women aged 18-45 living in Mashhad, Being literate, number of births less than 5, normal delivery, single baby and full-term, healthy, hospitalized in the active phase of labor, hemoglobin above 8, not having a history of mental illness, Not using specific chemical or herbal medicines, no addiction to drugs, alcohol, psychological and tobacco, no history of uterine surgery or caesarean, no use of drug analgesia to reduce labor pain, no severe bleeding in postpartum (bleeding that requires drug therapy or blood transfusion and transfer to the operating room), absence of the complications during labor, baby weight between 2500-4000 g, absence of neonatal complications and no history of allergy to mummy according to the mother of self-report.
Exclusion criteria:
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of women to two groups of mummy suppositories and placebo is random, which will be done with a random sequence created by the site "sealedenvelope.com" and random blocking (blocks of 4).
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo suppository is prepared by using polyethylene glycol and non-effect color to match the color of the placebo with the original drug. For blinding, mummy and placebo rectal suppositories are prepared by the pharmacist consultant in similar forms (appearance, color and packaging) with two different codes. Each of the suppositories has a code that was chosen by lottery and only the pharmacist consultant is aware of it. Women who are eligible to enter the study are placed in groups in according to code numbers.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
School of Nursing and Midwifery, Shahid Dr. Kharazmi Educational Complex, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square, , Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2024-03-05, 1402/12/15
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.136

Health conditions studied

1

Description of health condition studied
postpartum hemorrhage in women
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
postpartum hemorrhage
Timepoint
The amount of bleeding during the third stage of labor and the first 4 hours after delivery
Method of measurement
The amount of blood measured by the blood collection bag (ml) in the third stage of labor, the amount of blood calculated by weighing the sheet and pad (ml) in the first, second, third and fourth hour after delivery and finally the total volume Blood lost in four hours after delivery (blood amount calculated by Drosheet and pad) and final blood volume lost (blood amount calculated by blood collection bag and blood amount calculated by Drosheet and pad). Bleeding after childbirth is calculated by weighing and calculating the amount of blood collected in a plastic blood collection bag. This bag is cone-shaped and transparent, the size of the opening of the bag is 40 cm and the height of the bag is 50 cm, and the dimensions of the laminated fabric are two layers (60 x 80 cm), which expands under the mother's buttocks.

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group, after removing the placenta and fetal membranes, the first dose of mummy rectal suppository and the next dose with an interval of 2 hours by the researcher were administered. Bleeding rate using droshit blood collection bag and hygienic pad during the third stage of labor and the first 4 hours after delivery were measured.
Category
Treatment - Other

2

Description
In the control group, after removal of the placenta and fetal membranes, the first dose of placebo rectal suppository and the next dose with an interval of 2 hours by the researcher were administered. Bleeding rate using droshit blood collection bag and hygienic pad during the third stage of labor and the first 4 hours after delivery were measured.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Umm al-Binin Hospital (s)
Full name of responsible person
Nahid Sahebdel
Street address
Corner of Ayatollah Behjat 16, Zarineh Crossroad, Mashhad, Razavi Khorasan, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9144734767
Phone
+98 51 3223 1061
Email
SahebdelN1@mums.ac.ir

2

Recruitment center
Name of recruitment center
Mashhad Shahid Hashminejad Hospital
Full name of responsible person
Seyyed Mohamad Mousavi
Street address
End of Aburihan Blvd, Mufteh St., Mashhad, Razavi Khorasan, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9145919618
Phone
+98 51 3273 7011
Email
MosaviMH@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahmoud Mohammadzadeh Shabestari
Street address
Eastern Door of University Campus, Azadi Square, Mashhad, Razavi Khorasan, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
ShabestariMM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Zahra Karimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Shahid Dr. Kharazmi Educational Complex, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square , Razavi Khorasan, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
karimifz@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Zahra Karimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Shahid Dr. Kharazmi Educational Complex, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square , Razavi Khorasan, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
karimifz@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Zahra Karimi
Position
Fatemeh Zahra Karimi
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Shahid Dr. Kharazmi Educational Complex, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square , Razavi Khorasan, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
karimifz@mums.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
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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