The effect of delayed umbilical cord clamping in term cesarean delivery on the mother and child's short-term outcomes
.
Design
A randomized clinical trial, with two parallel arms, a blind, randomized phase 3 will be conducted on 118 women candidates for elective cesarean section. Eligible people will be selected during hospitalization in the delivery room using the available method and then will be assigned to two intervention and control groups using a random block of 4. Blocks of 4 will be generated using a table of random numbers.
Settings and conduct
The research population includes all eligible mothers undergoing elective cesarean section hospitalized in Ayatollah Mousavi Teaching Hospital, Zanjan will be assigned. In the present study, patients will be blind about the allocation of groups. In the intervention group, the umbilical cord of the baby during cesarean section will be one minute after birth. In the control group, the time of tying the umbilical cord will be immediately after the baby's birth.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Gestational age 37 to 41 weeks
Candidate for caesarean section
Singleton pregnancy
Term pregnancy
Exclusion criteria
Having a high-risk pregnancy
Emergency caesarean section
Fetal distress
Abnormalities of the fetus based on ultrasound
Fetal growth restriction
Intervention groups
In the intervention group, the baby's umbilical cord will be clamped one minute after birth. In the control group, the time to tie the umbilical cord will be clamped immediately after the birth of the baby.
Main outcome variables
Hemoglobin; Hematocrit; Platelet ; Blood lost during the operation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230507058111N1
Registration date:2024-04-25, 1403/02/06
Registration timing:registered_while_recruiting
Last update:2024-04-25, 1403/02/06
Update count:0
Registration date
2024-04-25, 1403/02/06
Registrant information
Name
nassim ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3542 2706
Email address
nassimahmadi9458@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-19, 1403/01/31
Expected recruitment end date
2024-08-19, 1403/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of delayed umbilical cord clamping in term cesarean delivery on the mother and child's short-term outcomes
Public title
The effect of delayed umbilical cord clamping in term cesarean delivery on the mother and child's short-term outcomes
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age 37 to 47 Weeks
Candidate for caesarean section
Singleton pregnancy
Term pregnancy
Exclusion criteria:
Having a high-risk pregnancy
Emergency caesarean section
Fetal distress
Abnormalities of the fetus based on sonography
Fetal growth restriction
Age
From 16 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
118
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible people will be assigned using convenience method during hospitalization in the delivery room. Blocks of 4 will be selected using a random number table so that the sample size reaches 59 people per each group. Blocking will be done by a person not involved in sampling.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, all patients will not know about the allocation of groups due to receiving anaesthesia for cesarean section.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zanjan University of Medical Sciences
Street address
Dr. Youssef Sobuti Blvd , Zanjan University of Medical Sciences, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956184
Approval date
2024-01-15, 1402/10/25
Ethics committee reference number
IR.ZUMS.REC.1402.239
Health conditions studied
1
Description of health condition studied
Delayed separation of umbilical cord
ICD-10 code
P96.82
ICD-10 code description
Delayed separation of umbilical cord
Primary outcomes
1
Description
Hemoglobin
Timepoint
Before the operation and 6 hours after the operation
Method of measurement
Laboratory
2
Description
Hematocrit
Timepoint
Before the operation and 6 hours after the operation
Method of measurement
Laboratory
3
Description
platelet
Timepoint
Before the operation and 6 hours after the operation
Method of measurement
Laboratory
4
Description
Average blood loss during cesarean section
Timepoint
After cesarean section
Method of measurement
The difference in the weight of gases used before and after cesarean section plus the amount of suctioned blood
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A group of mothers who undergo delayed umbilical cord clamping
Category
N/A
2
Description
Control group: A group of mothers who do not undergo delayed umbilical cord clamping
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Mousavi Zanjan Hospital
Full name of responsible person
Behnaz Molaie
Street address
Dr. Yusuf Sobuti .Blvd, Zanjan University of Medical Sciences, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3346 0180
Email
info@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Nassim Ahmadi
Street address
Dr. Youssef Sobuti Blvd, Zanjan University of Medical Sciences,Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3313 0001
Email
info@zums.ac.ir
Web page address
https://zums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Nassim Ahmadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Dr. Youssef sobuti Blvd., Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 41 3542 2706
Email
Nassimahmadi9458@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Behnaz Molai
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Dr. Youssef Sobuti Blvd., Zanjan University of Medical Sciences, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 41 3542 2706
Email
molai@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Nassim Ahmadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Dr. Youssef Sobuti Blvd., Zanjan University of Medical Sciences, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 41 3542 2706
Email
Nassimahmadi9458@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD