| CTRI Number |
CTRI/2024/01/061865 [Registered on: 25/01/2024] Trial Registered Prospectively |
| Last Modified On: |
19/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [CUT CORD MILKING VS EARLY CORD CLAMPING] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
the placental transfusion in cut-umbilical cord milking vs Early cord clamping |
|
Scientific Title of Study
|
Cut umbilical cord milking(C-UCM)as a mode of placental transfusion in twin pregnancies of 30-37 weeks gestation-a randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bijan Saha |
| Designation |
Associate Professor |
| Affiliation |
SSKM HOSPITAL |
| Address |
DEPARTMENT OF NEONATOLOGY
IPGMER AND SSKM HOSPITAL
KOLKATA
DEPARTMENT OF NEONATOLOGY
IPGMER AND SSKM HOSPITAL
KOLKATA
Kolkata
WEST BENGAL
700020
India |
| Phone |
90513891230 |
| Fax |
|
| Email |
bijansaha18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bijan Saha |
| Designation |
Associate Professor |
| Affiliation |
SSKM HOSPITAL |
| Address |
DEPARTMENT OF NEONATOLOGY
IPGMER AND SSKM HOSPITAL
KOLKATA
DEPARTMENT OF NEONATOLOGY
IPGMER AND SSKM HOSPITAL
KOLKATA
Kolkata
WEST BENGAL
700020
India |
| Phone |
9051389120 |
| Fax |
|
| Email |
bijansaha18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ASHADUR ZAMAL |
| Designation |
POST DOCTORAL TRAINEE |
| Affiliation |
SSKM HOSPITAL |
| Address |
DEPARTMENT OF NEONATOLOGY
IPGMER AND SSKM HOSPITAL
KOLKATA
DEPARTMENT OF NEONATOLOGY
IPGMER AND SSKM HOSPITAL
KOLKATA
Kolkata
WEST BENGAL
700020
India |
| Phone |
9874731846 |
| Fax |
|
| Email |
zamalashadur@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF NEONATOLOGY |
| Address |
DEPARTMENT OF NEONATOLOGY
IPGMER AND SSKM HOSPITAL
KOLKATA |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DEPARTMENTAL FUNDING |
DEPARTMENT OF NEONATOLOGY
IPGMER AND SSKM HOSPITAL
KOLKATA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr BIJAN SAHA |
SSKM HOSPITAL |
DEPARTMENT OF NEONATOLOGY
Kolkata
WEST BENGAL |
9051389120
bijansaha18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I999||Unspecified disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
cut cord miking |
In both arms, the obstetrician shall clamp and cut the umbilical cord within 30 seconds of delivery. In the milked group, the cord shall be cut keeping a length of about 30 cm from the umbilical stump (length measured with the help of a dedicated sponge holding forceps). The baby will be then immediately passed on to the resuscitation team and positioned under the radiant warmer. One resident shall perform the cord milking while another resident will resuscitate the baby according to NRP protocol. With one hand, the cord would be held up, untwisted and then milked from the clamped end towards the baby three times at an average speed of ten cm/ sec. Properly functioning wall-mounted clocks shall be present in the delivery room for accurately noting down the timings. After the procedure, the extra length of the cord will be cut and clamped at a distance of about 3 cm from the umbilical stump. |
| Comparator Agent |
EARLY CORD CLAMPING |
In both arms, the obstetrician shall clamp and cut the umbilical cord within 30 seconds of delivery. In the milked group, the cord shall be cut keeping a length of about 30 cm from the umbilical stump (length measured with the help of a dedicated sponge holding forceps). The baby will be then immediately passed on to the resuscitation team and positioned under the radiant warmer. One resident shall perform the cord milking while another resident will resuscitate the baby according to NRP protocol. With one hand, the cord would be held up, untwisted and then milked from the clamped end towards the baby three times at an average speed of ten cm/ sec.7A properly functioning wall-mounted clocks shall be present in the delivery room for accurately noting down the timings. After the procedure, the extra length of the cord will be cut and clamped at a distance of about 3 cm from the umbilical stump. In the control arm or non-milked group, no cord milking shall be performed and the cord will be simply cut and clamped 3 cm from the stump. The necessary stabilization and subsequent care will be similar to that received in the intervention arm. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
during the delivery time |
|
| ExclusionCriteria |
| Details |
i. Neonates born at gestation less than 30weeks or more than or equal to 37 weeks
ii. Outborn neonates
iii. Major lethal congenital anomalies or known/suspected chromosomal anomalies
iv. Fetal hydrops
v. Rh isoimmunization
vi. Cord prolapse, cord abnormalities such as true knots
vii. Twin-to-twin transfusion syndrome
viii. Discordant twins (a weight difference of >20%)
ix. Short umbilical cord length
x. Noparentalconsent
xi. Residence beyond 20 kms radius from our unit.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine venous hematocrit at 48 (+/- 4 ) hours of
postnatal age
|
To determine venous hematocrit at 48 (+/- 4 ) hours of
postnatal age
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a. Hct and serum ferritin at 6weeks of postnatal age
b. Hb,hct and bilirubin level at 12,48hours of postnatal age.
c. Heartrate, mean bloodpressure in the first 48 hours of life
d. Hyperbilirubinemia requiring phototherapy
e. Symptomatic polycythemia in first 48 hours
f. Incidence of hemodynamically significant patent ductus arteriosus,NEC (Stage 2 and above), IVH on cranial ultrasound(grade3andabove), ROP(stage2andabove) and BPD
g. Total number of PRBC transfusions till 6 weeks of postnatal age
h. Duration of hospital stay
i. Death up to 6weeks of postnatal age
|
6 weeks post-natal age |
|
|
Target Sample Size
|
Total Sample Size="166"
Sample Size from India="166"
Final Enrollment numbers achieved (Total)= "168"
Final Enrollment numbers achieved (India)="168" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
05/02/2024 |
| Date of Study Completion (India) |
14/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
not applicable now |