| 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
|
|
|
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
|
|
|
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. |