| CTRI Number |
CTRI/2018/01/011308 [Registered on: 12/01/2018] Trial Registered Prospectively |
| Last Modified On: |
30/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Blood from umbilical cord will be drained after delivery of baby to see how long it takes for placental delivery |
|
Scientific Title of Study
|
Effect of placental cord blood drainage in the management of third stage of labor. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chaithra Rani K |
| Designation |
Post graduate |
| Affiliation |
Kasturba medical college, Manipal |
| Address |
Room No. 213, Sonia hostel, Kasturba medical college, Manipal, Udupi district
Kasturba medical college, Manipal, Udupi district- 576104
Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9538698442 |
| Fax |
|
| Email |
chaithrarani3110@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vidyashree |
| Designation |
Assistant professor |
| Affiliation |
Kasturba medical college, Manipal |
| Address |
Deprtment of obstetrics and gynecology, Kasturba medical college, Manipal, Udupi district
Udupi
KARNATAKA
576104
India |
| Phone |
9901731619 |
| Fax |
|
| Email |
drvidyaganesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chaithra Rani K |
| Designation |
Post graduate |
| Affiliation |
Kasturba medical college, Manipal |
| Address |
Room No. 213, Sonia hostel, Kasturba medical college, Manipal, Udupi district
Kasturba medical college, Manipal, Udupi district- 576104
Karnataka
KARNATAKA
576104
India |
| Phone |
9538698442 |
| Fax |
|
| Email |
chaithrarani3110@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba medical colloege, Manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba medical college Manipal |
| Address |
Madhav nagar, Near tiger circle, Manipal, Karnataka- 576104 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Chaithra rani k |
Kasturba medical college, Manipal |
Labor room, Department of OBG, KMC, Manipal
Madhav nagar, Near tiger circle, Maipal
Udupi
KARNATAKA |
9538698442
chaithrarani3110@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Kastura hospital, Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, Term pregnant ladies who undergo normal vaginal delivery at kasturba hospital, Manipal, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Singleton pregnancy, Vertex presentation, Gestational age ≥37 weeks, vaginal delivery, No major medical (or) obstetric complications. |
|
| ExclusionCriteria |
| Details |
Hemoglobin <10 gm/dl, History of APH, Instrumental delivery, cesarean section, Multiple pregnancy, Mal-presentations, Large baby (more than 3.5 kg), Polyhydramnios, known coagulations disorders, Previous surgeries on the uterus. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of the third stage of labor |
Duration of the third stage of labor |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
ï‚´Postpartum blood loss
ï‚´Incidence of postpartum hemorrhage
ï‚´Incidence of retained placenta
ï‚´Requirement for the manual removal of the placenta
ï‚´Need for blood transfusion
ï‚´Changes in maternal hemoglobin after delivery
ï‚´Additional uterotonic drugs required |
1 year |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/01/2018 |
| Date of Study Completion (India) |
15/09/2018 |
| 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
Modification(s)
|
The study has been published in International Journal of Clinical Obstetrics and Gynaecology |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The active management of third stage of labor, as approved by FIGO in 2003, acts prompt to time to combat postpartum hemorrhage, should it occur, so that the valuable lives of pregnant mother can be saved. The present study is designed to evaluate and compare the efficacy of placental cord blood drainage after vaginal delivery, versus no placental cord blood drainage as a part of active management of third stage of labor. |