| CTRI Number |
CTRI/2017/11/010496 [Registered on: 15/11/2017] Trial Registered Prospectively |
| Last Modified On: |
20/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Use of oxytocin at different rates for contraction of uterus during caesarean delivery in patients in labour |
|
Scientific Title of Study
|
Efficacy of different infusion rates of oxytocin for maintaining uterine tone during non-elective caesarean section in labouring patients– a randomized, double-blind controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Medha Mohta |
| Designation |
Director Professor |
| Affiliation |
University College of Medical Sciences and GTB Hospital |
| Address |
Department of Anaesthesiology and Critical Care, University College of Medical Sciences and GTB Hospital
East
DELHI
110095
India |
| Phone |
9868399626 |
| Fax |
|
| Email |
medhamohta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Medha Mohta |
| Designation |
Director Professor |
| Affiliation |
University College of Medical Sciences and GTB Hospital |
| Address |
Department of Anaesthesiology and Critical Care, University College of Medical Sciences and GTB Hospital
DELHI
110095
India |
| Phone |
9868399626 |
| Fax |
|
| Email |
medhamohta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sheeba Siddiqui |
| Designation |
Postgraduate Student |
| Affiliation |
University College of Medical Sciences and GTB Hospital |
| Address |
Department of Anaesthesiology and Critical Care, University College of Medical Sciences and GTB Hospital
East
DELHI
110095
India |
| Phone |
8800511743 |
| Fax |
|
| Email |
drs.siddiqui.156@gmail.com |
|
|
Source of Monetary or Material Support
|
| University College of Medical Sciences and GTB Hospital, Dilshad Garden, Delhi-110095 |
|
|
Primary Sponsor
|
| Name |
University College of Medical Sciences and GTB Hospital |
| Address |
Dilshad Garden, Delhi-110095 |
| Type of Sponsor |
Government 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 |
| Dr Medha Mohta |
University College of Medical Sciences and GTB Hospital |
Department of
Anaesthesiology and
Critical Care, 2nd Floor,
OT Block
East
DELHI |
9868399626
medhamohta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Full term pregnant patients in labour undergoing caesarean section, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Oxytocin 10.0 |
After an initial oxytocin injection for initiation of uterine contraction, the patients will receive oxytocin infusion @ 10 IU/hr for maintenance of uterine contraction |
| Intervention |
Oxytocin 2.5 |
After an initial oxytocin injection for initiation of uterine contraction, the patients will receive oxytocin infusion @ 2.5 IU/hr for maintenance of uterine contraction |
| Intervention |
Oxytocin 5.0 |
After an initial oxytocin injection for initiation of uterine contraction, the patients will receive oxytocin infusion @ 5.0 IU/hr for maintenance of uterine contraction |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Healthy females with 37 weeks or more gestation,
Uncomplicated, singleton pregnancy,
Labouring patients who have received oxytocin for induction or augmentation of labour
|
|
| ExclusionCriteria |
| Details |
Known drug allergy to oxytocin,
Maternal complications e.g. pre-eclampsia, diabetes mellitus, cardiovascular disease, cerebrovascular disease, bronchial asthma,
Known risk factors for postpartum haemorrhage e.g. Multiple gestation, abnormal placentation, uterine fibroid, macrosomia, hydramnios, history of postpartum haemorrhage or uterine atony
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Estimated blood loss during intraoperative period |
Estimated blood loss during intraoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Adequacy of uterine tone,
Need for additional uterotonics,
Haemoglobin level at 4 and 24 hours,
Any oxytocin related side-effects |
During surgery and till 24 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
Final Enrollment numbers achieved (Total)= "105"
Final Enrollment numbers achieved (India)="105" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
21/11/2017 |
| Date of Study Completion (India) |
05/03/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Spinal anaesthesia will be administered as per standard protocol. At the
time of clamping the umbilical cord, oxytocin 3 U will be administered i.v.
over a period of 1 min to all the patients. Immediately after this injection,
oxytocin infusion will be started at a rate depending on group allocation viz.
2.5 IU/hr or 5 IU/hr or 10 IU/hr. Inadequate uterine tone will be managed with maximum of two rescue doses of oxytocin and carboprost thereafter, if required. Estimated blood loss, adequacy of uterine tone, need for additional uterotonics, change in haemoglobin level at 4 and 24 hours, and any oxytocin related side-effects will be assessed. |