| CTRI Number |
CTRI/2022/09/046096 [Registered on: 30/09/2022] Trial Registered Prospectively |
| Last Modified On: |
07/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study comparing the effects of oxytocin administered at different rates during planned caesarean surgery. |
|
Scientific Title of Study
|
Comparative study of different infusion rates of oxytocin in elective caesarean section. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kunal Singh |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Patna |
| Address |
Department of Anaesthesiology, All India Institute of Medical
Sciences Patna, Phulwarisharif, Patna
Patna
BIHAR
801507
India |
| Phone |
9411514945 |
| Fax |
|
| Email |
drsinghkunal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kunal Singh |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Patna |
| Address |
Department of Anaesthesiology, All India Institute of Medical
Sciences Patna, Phulwarisharif, Patna
BIHAR
801507
India |
| Phone |
9411514945 |
| Fax |
|
| Email |
drsinghkunal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kunal Singh |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Patna |
| Address |
Department of Anaesthesiology, All India Institute of Medical
Sciences Patna, Phulwarisharif, Patna
BIHAR
801507
India |
| Phone |
9411514945 |
| Fax |
|
| Email |
drsinghkunal@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Patna |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Patna |
| Address |
Department of Anaesthesiology, All India Institute of Medical
Sciences Patna, Phulwarisharif, Patna |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Amarjeet Kumar |
Department of Anaesthesiology, All India Institute of Medical Sciences Patna, Phulwarisharif, Patna |
| Rajnish Kumar |
Department of Anaesthesiology, All India Institute of Medical
Sciences Patna, Phulwarisharif, Patna |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Kunal Singh |
All India Institute of Medical Sciences Patna |
Department of Anaesthesiology, All India Institute of Medical
Sciences Patna, Phulwarisharif, Patna
Patna
BIHAR |
9411514945
drsinghkunal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences, Patna Institutional Ethics Committee |
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 |
| Comparator Agent |
Oxytocin infusion 2.5 IU/hour |
All patients will receive 1 IU of oxytocin intravenously over the duration of one minute when the umbilical cord is clamped. Following this injection, an oxytocin infusion will commence at a rate of 2.5 IU/hour. This treatment will last for four hours. |
| Intervention |
Oxytocin infusion 5 IU/hour |
All patients will receive 1 IU of oxytocin intravenously over the duration of one minute when the umbilical cord is clamped. Following this injection, an oxytocin infusion will commence at a rate of 5 IU/hour. This treatment will last for four hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant patients undergoing elective caesarean section in spinal anaesthesia will be included in the study.
1. Uncomplicated, singleton pregnancy
2. ASA class 1 & 2 |
|
| ExclusionCriteria |
| Details |
1. Patients with multiple pregnancies
2. Complicated pregnancies, risk factors for postpartum haemorrhage (PPH)
3. Contraindication to spinal anaesthesia and
4. Patients in active labour.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure the total estimated blood loss (EBL) in intraoperative period after the infusion of 5U/h and 2.5 U/h of oxytocin during elective caesarean section under spinal anaesthesia. |
Intraoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To measures the following after the administration of oxytocin:
1. Adequacy of uterine tone.
2. Need for additional uterotonics.
3. Incidence of postpartum haemorrhage (PPH).
4. Any oxytocin-related side effects for example: tachycardia, hypotension, chest pain. |
Intraoperative period |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/10/2022 |
| Date of Study Completion (India) |
05/07/2023 |
| 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
|
Lavoie A, McCarthy RJ, Wong CA. The ED90 of prophylactic oxytocin infusion after delivery of the placenta during cesarean delivery in laboring compared with nonlaboring women: an up-down sequential allocation dose-response study. Anesth Analg. 2015 Jul;121(1):159-164 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Oxytocin is the most commonly used uterotonic agent in obstetrics. It is routinely administered after both normal and operative delivery to initiate and maintain adequate uterine contractility for minimizing blood loss and preventing postpartum haemorrhage. Several regimens of oxytocin have been tested during caesarean delivery (CD) with variable wanted and unwanted effects. Since appropriate dose of oxytocin has not been established this study will be carried out with aim to compare effects of low dose oxytocin given as IV bolus plus infusion. |