| CTRI Number |
CTRI/2024/08/072039 [Registered on: 07/08/2024] Trial Registered Prospectively |
| Last Modified On: |
05/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
to check effect on blood loss on labor |
|
Scientific Title of Study
|
Effect of timing of oxytocin administration in third stage of labor |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHIKHA RANI |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical college Chandigarh |
| Address |
Room no- 341, Department of Obstetrics and Gynaecology , Government Medical College Chandigarh
Room no- 341, Department of Obstetrics and Gynaecology , Government Medical College Chandigarh
Chandigarh
CHANDIGARH
160032
India |
| Phone |
8288889179 |
| Fax |
|
| Email |
shikhataneja2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shikha rani |
| Designation |
Assitant professor |
| Affiliation |
Government Medical college chandigarh |
| Address |
Room no- 341, Department of Obstetrics and Gynaecology , Government Medical College Chandigarh
Room no- 341, Department of Obstetrics and Gynaecology , Government Medical College Chandigarh
Chandigarh
CHANDIGARH
160032
India |
| Phone |
8288889179 |
| Fax |
|
| Email |
shikhataneja2000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sandeep Galgat |
| Designation |
junior resident |
| Affiliation |
Government Medical college chandigarh |
| Address |
room no 341 department of obstetrics and gynaecology Government Medical college chandigarh
room no 341 department of obstetrics and gynaecology Government Medical college chandigarh
Chandigarh
CHANDIGARH
160032
India |
| Phone |
8288889179 |
| Fax |
|
| Email |
galgatsandeep786@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 341, Department of Obstetrics and Gynaecology , Government Medical College sector -32 Chandigarh Pin code -160032 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 SANDEEP GALGAT |
Govt medical college Sector -32 chandigarh |
Labor Room 15 Dept of obstetrics and gynaecology Government medical college Sector -32 chandigarh
Chandigarh
CHANDIGARH |
01722601023
GALGATSANDEEP786@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institiutional ethics Committee GMCH 32 chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
Injection of 10 units of oxytocin administration through IM route within 15 seconds of delivery of the baby. |
| Comparator Agent |
Group B |
Injection of 10 units of oxytocin administration through IM route at 3 minutes of delivery of the baby |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Inclusion Criteria
The following women undergoing vaginal birth will be eligible for enrollment in the study:
Gestation greater than 35 weeks of gestation
Singleton gestation
Last Hb during pregnancy more than 8.0 gm/dl
|
|
| ExclusionCriteria |
| Details |
Pregnant women with coagulopathy and bleeding disorder
Pregnant women with APH (Placenta previa, placental abruption, uterine rupture and vasa previa)
Fetal distress
Severe FGR (fetal growth retardation
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome
Maternal mean blood loss during delivery at 0
Neonatal outcome
Birth weight within 5 minutes
Apgar score within 5 minutes
Need for phototherapy after delivery
Neonatal intensive care unit admission
Packed cell volume in neonate at 6+2 hours of age will be done
|
Primary outcome
Maternal mean blood loss during delivery at 0
Neonatal outcome
Birth weight within 5 minutes
Apgar score within 5 minutes
Need for phototherapy after delivery
Neonatal intensive care unit admission
Packed cell volume in neonate at 6+2 hours of age will be done
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Neonatal outcome
Birth weight
Apgar score
Need for phototherapy
Neonatal intensive care unit admission
Packed cell volume in neonate at 6+2 hours of age will be done
|
at zero hours that is at the time of delivery |
|
|
Target Sample Size
|
Total Sample Size="208"
Sample Size from India="208"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
31/08/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
A total of 208 patients with defined inclusion criteria above will be randomly allocated in to two groups of 104 patients each using computer generated random number table and the allocated number will be secured in a coded opaque sealed envelope. The patient will be allocated in one of following two groups. Group A (N=104): patient will be given injection oxytocin 10 units IM within 15 secs of delivery followed by delayed cord clamping.8 Group B (N=104): Patient will be given injection oxytocin 10 units IM at 3 minutes of delayed cord clamping.8 |