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CTRI Number  CTRI/2024/09/073451 [Registered on: 05/09/2024] Trial Registered Prospectively
Last Modified On: 04/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Comparison of early versus delayed umbilical cord clamping in premature babies 
Scientific Title of Study   Comparison of early versus delayed cord clamping in preterm deliveries 
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 Madhusmita Shyam 
Designation  Post graduate trainee 
Affiliation  Silchar medical college and hospital 
Address  Department of obstetrics and gynecology, Silchar medical college and hospital, Silchar 788014 ASSAM India

Cachar
ASSAM
788014
India 
Phone  8822820155  
Fax    
Email  madhusmitashyam10@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neeta Sarma 
Designation  Associate professor  
Affiliation  Silchar medical college and hospital 
Address  Department of obstetrics and gynecology, Silchar medical college and hospital, Silchar 788014 ASSAM India

Cachar
ASSAM
788014
India 
Phone  9864044623  
Fax    
Email  neetasarma15@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Neeta Sarma 
Designation  Associate professor  
Affiliation  Silchar medical college and hospital 
Address  Department of obstetrics and gynecology, Silchar medical college and hospital, Silchar 788014 ASSAM India

Cachar
ASSAM
788014
India 
Phone  9864044623  
Fax    
Email  neetasarma15@gmail.com  
 
Source of Monetary or Material Support  
Silchar medical college and hospital, Cachar, 788014 Assam India  
 
Primary Sponsor  
Name  Dr Madhusmita Shyam 
Address  Silchar medical college and hospital, Silchar, 788014, Assam, India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 Madhusmita Shyam  Silchar medical college and hospital  Department of Obstetrics & Gynaecology, Mother and child building, labour room
Cachar
ASSAM 		 8822820155

madhusmitashyam10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Silchar Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  women with singleton pregnancy who delivered at a gestational age less than 37 week 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Comparison of early versus delayed cord clamping in preterm deliveries  Participants were divided into two groups, namely group A and group B, through simple randomization. Group A includes patients with early cord clamping, and Group B includes patients with delayed cord clamping.Following the delivery, neonates from both groups were evaluated for 1.APGAR scores 2. Incidence of jaundice 3. The necessity for neonatal ICU admission 4. Blood tests for neonatal hemoglobin and hematocrit were performed 4 hours post-delivery and again after 24 hours. 5. Serum bilirubin levels were measured at 12 hours post-delivery and monitored on the third day for follow-up. The maternal intra-delivery blood loss was monitored by recording the number of operative towels used and the volume of blood in the suction unit. Additionally, maternal complete blood count (CBC) tests were conducted after 12 hours. All mothers were monitored for primary postpartum hemorrhage (PPH) and assessed for the need for blood transfusions within the initial 24 hours.  
Comparator Agent  Early cord clamping  Participants are divided into two groups where group A underwent early cord clamping and group B underwent delayed clamping. Early cord clamping is done within 30 seconds whereas delayed is done after 1 minutes of birth. Now Delayed cord clamping is compared with early cord clamping to evaluate the maternal outcome in terms of blood loss undergoing a cesarean section and fetal outcome. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1. Women with singleton pregnancies who delivered at a gestational period of less than 37 weeks were included in the study. 
 
ExclusionCriteria 
Details  1. Women experiencing intra-partum surgical complications such as uterine artery injury, lower segment extension, or IUFD were excluded.
2. Pregnant women suffering from chronic medical conditions like diabetes and hypertension were not part of the study.
3. Cases featuring abnormal placentation, placental abruption, liquor abnormality, or anomalous fetuses were also excluded from the research.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess delayed versus early umbilical cord clamping in mothers undergoing delivery regarding the maternal intra-operative blood loss.  From admission of patient to 24 hrs post delivery 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effect of delayed cord clamping versus early cord clamping regarding the neonatal outcomes.  From admission of patient to delivery of the baby & upto 3 days perioperatively. 
 
Target Sample Size   Total Sample Size="380"
Sample Size from India="380" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   15/09/2024 
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="1"
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   The third stage of labour is defined as the period of time between the birth of an infant and the complete expulsion of the placenta. The timing of umbilical cord clamping, more specifically, early cord clamping versus Obstetrics delayed cord clamping remains a controversial issue and a subject of continuing debate.

 DCC in preterm infants also showed many significant benefits, including establishing better red blood cell volume, decreasing the need for blood transfusion, improving the transitional circulation, and lowering the incidence of intraventricular haemorrhage and necrotizing enterocolitis As a result, the American College of Obstetricians and Gynecologists (ACOG) recommends DCC for at least 30–60 seconds after birth in both preterm and term newborns 

DCC presents a number of clinically relevant benefits, with minimal (if any) additive risks, even in healthy infants. These include decreasing neonatal anaemia and iron deficiency, which may have an impact on development. These advantages are also present in populations in which iron deficiency has a relatively low prevalence. Therefore, a universal approach to DCC in the term infant can be justified, given the currently available evidence. Hence, this study aims to evaluate the effect of Early cord clamping and delayed cord clamping during delivery.
 
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