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CTRI Number  CTRI/2024/07/070137 [Registered on: 07/07/2024] Trial Registered Prospectively
Last Modified On: 27/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Delayed Cord clamping at one minute vs Physiologic cord clamping in terms of outcomes for the mother and baby 
Scientific Title of Study   A Randomized controlled trial to compare the feto-maternal outcomes after physiologic cord clamping vs delayed cord clamping at one minute in women undergoing elective caesarean section at term 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mishu Mangla 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Bibinagar, Hyderabad 
Address  Department of Obstetrics and Gynaecology All India Institute of Medical Sciences Bibinagar Hyderabad

Hyderabad
TELANGANA
508126
India 
Phone  9493980850  
Fax    
Email  mishusingla83@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nireesha Bukke 
Designation  post graduate student 
Affiliation  All India Institute of Medical Sciences, Bibinagar, Hyderabad 
Address  Department of Obstetrics and Gynaecology All India Institute of Medical Sciences Bibinagar Hyderabad

Hyderabad
TELANGANA
508126
India 
Phone  8639172708  
Fax    
Email  bukkenireesha99@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mishu Mangla 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Bibinagar, Hyderabad 
Address  Department of Obstetrics and Gynaecology All India Institute of Medical Sciences Bibinagar Hyderabad

Hyderabad
TELANGANA
508126
India 
Phone  9493980850  
Fax    
Email  mishusingla83@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Bibinagar, Hyderabad, Telangana. 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  All India Institute of Medical Sciences, Bibinagar, Hyderabad- 508126, Telangana, INDIA 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mishu Mangla  All India Institute of Medical Sciences  Room no. 19/20, Department of Obstetrics and Gynaecology, AIIMS Bibinagar Hyderabad
Hyderabad
TELANGANA 
9988805850

mishusingla83@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (AIIMS BBN-IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Delayed cord clamping  Cord clamping and cutting at 60 seconds of birth of baby. 
Intervention  Physiologic cord clamping after birth  The baby and placenta will be handed over to neonatologist, umbilical cord clamp will be applied by the neonatologist only after complete cessation of blood flow across umbilical cord. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Patients, aged 18-45 years, scheduled to undergo a planned/elective caesarean section in AIIMS Bibinagar for a routine indication.
2. Singleton pregnancy
3. Gestational age of the fetus is more than 37 weeks
4. No e/o fetal growth restriction or uteroplacental insufficiency
 
 
ExclusionCriteria 
Details  1. Patients refusing to give consent to participate in the study
2. Patients undergoing emergency caesarean section
3. Women with pregnancy carrying fetus with congenital anomaly
4. Patients with any cause of high-risk pregnancy,
5. Babies needing urgent neonatal resuscitation, or
6. Any other indication mandating immediate cord clamping, like placenta praevia, Rh incompatibility.
7. Neonates with any signs suggestive of distress, or not crying immediately after birth.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Evaluate the effect of physiologic cord clamping versus delayed cord clamping at 1 minute on the amount of postpartum haemorrhage .  At the time of delivery 
 
Secondary Outcome  
Outcome  TimePoints 
Determine the impact of physiologic cord clamping versus delayed cord clamping at one minute on neonatal admissions due to any of the followings
• Respiratory distress since birth (or)
• Requiring positive pressure ventilation for more than 30 secondes (or)
• Noenatal jaundice (or)
• Noenatal polycythemia (or)
• Any other procedure related events/ complications
 
At the time of discharge from NICU  
Duration of third stage of labour and total surgical time
 
At the time of Caesarean Section 
Serum ferritin levels of the baby  6 months of life 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Umbilical cord clamping is a pivotal step in the third stage of labor which serves to separate the newborn from the placenta. The timing of this procedure has become a global point of contention. Although several reputable medical organizations, including the American College of Obstetrics and Gynaecologists (ACOG) (9), American Academy of Paediatrics (AAP) [10], European Resuscitation Council [11], National Institute for Health and Care Excellence (NICE) [12], Society of Obstetrician and Gynaecologists of Canada [13], and the World Health Organization [14], advocate for Delayed Cord Clamping (DCC), there is a lack of consistency in its definition. The recommended duration of DCC in these society guidelines ranges from 30 seconds to 5 minutes or even longer, or until umbilical cord pulsation ceases. Surveys on DCC have also highlighted significant variations in its clinical implementation. The World Health Organization (WHO) categorizes early cord clamping as the clamping done within the initial 60 seconds after birth. Conversely, delayed cord clamping occurs between 1 to 3 minutes after birth or when the umbilical cord pulsations cease [1, 2]. In its 2014 Guideline on delayed cord clamping, WHO recommends a delay of at least 60 seconds before clamping, even when positive pressure ventilation is necessary, for both term and preterm infants [1]. This protocol underscores the significance of appropriate timing in ensuring the well-being of newborns during this crucial stage of childbirth. Although most of the leading scientific organisations of obstetrics and neonatology recommend delayed cord clamping, the definition of DCC used vary from one scientific society to another. While most of them recommend delaying clamping the cord to more than 60 seconds (4), some consider that it can be delayed up to 5 minutes if the new born is vigorous and p[laced in skin to skin contact with the mother (5).  The Pan American Health Organization (regional office of the World Health Organization) recommends “The optimal time to clamp the umbilical cord for all infants regardless of gestational age or fetal weight is when the circulation in the cord has ceased, and the cord is flat and pulseless (approximately 3 minutes or more after birth) (6). 

The advantages of delayed cord clamping, after the delivery of fetus have been widely documented in literature. Nevertheless, the potential impacts on maternal health remain uncertain, warranting a comprehensive investigation into its consequences. To date, only  few studies in the existing literature have focused on maternal mortality and hemorrhage as primary outcomes. Thus, there is a pressing need for additional research to thoroughly evaluate both maternal and neonatal outcomes following the shift in active management during the third stage of delivery (1-3). Allowing the baby to remain attached to the placenta via the umbilical cord after delivery does not pose any negative consequences for both the mother and the newborn. It’s important to recognize that in Western cultures until the 17th century, the practice of clamping and cutting the cord used to occur after the placenta was delivered. The shift to clamping before the placenta’s birth primarily happened for the sake of convenience [7, 8]. Therefore, the present study is planned to compare two different intervals of delayed cord clamping, one after 60 seconds, and second being physiological clamping of the cord after the delivery of placenta by neonatologist, after complete cessation of placental transfusion, on feto-maternal outcomes.

 
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