| CTRI Number |
CTRI/2023/05/053088 [Registered on: 24/05/2023] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Dose of oxytocin needed during cesarean in patients with pregnancy of less than 37 weeks |
|
Scientific Title of Study
|
Minimum effective dose of prophylactic oxytocin infusion during cesarean delivery: Comparison between patients with preterm versus term pregnancy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Asha Tyagi |
| Designation |
Professor |
| Affiliation |
University College of Medical Sciences and GTB Hospital |
| Address |
Department of Anaesthesiology and Critical Care,UCMS and GTB Hospital, Dilshad Garden,
Shahdra
New Delhi
DELHI
110095
India |
| Phone |
|
| Fax |
|
| Email |
drashatyagi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Asha Tyagi |
| Designation |
Professor |
| Affiliation |
University college of Medical Sciences and GTB Hospital |
| Address |
Department of Anaesthesiology and Critical Care,UCMS and GTB Hospital, Dilshad Garden,
Shahdra
New Delhi
DELHI
110095
India |
| Phone |
|
| Fax |
|
| Email |
drashatyagi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srishty Singla |
| Designation |
Post Graduate Resident 1st year |
| Affiliation |
University College of Medical Sciences and GTB Hospital |
| Address |
Department of Anaesthesiology and Critical Care,UCMS and GTB Hospital, Dilshad Garden,
Shahdra
East
DELHI
110095
India |
| Phone |
9953489108 |
| Fax |
|
| Email |
srishty.singla11@gmail.com |
|
|
Source of Monetary or Material Support
|
| University College of Medical Sciences and Guru Teg Bahadur Hospital |
|
|
Primary Sponsor
|
| Name |
University College of Medical Sciences and GTB Hospital |
| Address |
Dilshad Garden, Shahdra, Delhi |
| 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 Srishty Singla |
University College of Medical Science and GTB Hospital |
Department of
Anaesthesiology and
Critical Care, Dilshad
Garden, Shahdra
East
DELHI |
9953489108
srishty.singla11@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 |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Patients with preterm gestation scheduled for cesarean |
Titrated dose of oxytocin infusion according to sequential
allocation design;
Duration: started at time of fetal delivery and continued till end of surgery,
Dose will vary between 13 IU/hr to 36IU/hr depending on sequential allocation (dosing interval of 2 IU/hr). |
| Comparator Agent |
Patients with term pregnancy scheduled for cesarean |
Titrated dose of oxytocin infusion according to sequential
allocation design;
Duration: started at
time of fetal delivery and continued till end of surgery,
Dose will vary between 13 IU/hr to 36IU/hr depending
on sequential allocation (dosing interval of 2 IU/hr). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Posted for cesarean delivery under spinal block; either into the term or preterm cohort (defined as gestational age of completed 37 weeks (i.e., ≥259 days) or <37 weeks respectively. |
|
| ExclusionCriteria |
| Details |
Laboring with preoperative oxytocin use, or magnesium sulfate therapy, coagulopathy, history of previous uterine atony or postpartum hemorrhage or bleeding disorder or heart disease. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intraoperative uterine tone |
From 4 minutes of oxytocin initiation till end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Need of additional uterotonic as per obstetrician, for inadequate uterine tone |
At ANY time during surgery (after initiating oxytocin to end of surgery) |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
01/06/2023 |
| 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="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Objective: To evaluate and compare during cesarean delivery in patients with preterm and term pregnancy, the minimum effective dose (defined as ED90 i.e., dose expected to be adequate in 90% of target population) of prophylactic oxytocin infusion for achieving and maintaining adequate uterine tone. Methods: This will be a dual-arm, dose finding study, based on biased coin sequential allocation design. The patient, anesthesiologist conducting the case, and obstetrician will be blinded to the dose of oxytocin. All women aged >18 years, and posted for cesarean delivery under spinal block will be evaluated for inclusion, either into the term (completed 37 weeks) or preterm (<37 weeks) cohort. Matching will be done in the preterm and term cohorts for categories of confounding variables known to affect association of oxytocin dose and uterine contraction. Oxytocin administration: Oxytocin infusion will be initiated on clamping of the umbilical cord. The dose of the infusion will be 13 IU/h for the first patient in both cohorts. The designated hourly oxytocin dose will be added to normal saline in a 50 mL syringe, and infused via a syringe infusion pump at 50 mL/h. The dose in subsequent cases, for either cohort, will be determined by the response to oxytocin in previous patient of the particular cohort, based on biased sequential allocation method. The primary outcome measure is the adequacy of intraoperative uterine tone at 4 minutes and continued till the end of surgery, assessed by using 1 finger palpation method. When uterine tone is satisfactory, infusion of oxytocin will be continued till the end of surgery at the same rate. In case of an unsatisfactory tone, the infusion will be doubled and uterine massage initiated, followed by additional uterotonic is still required. Myometrial oxytocin receptor quantification: Full thickness myometrial biopsy will be taken from the upper edge of the uterine transverse incision made for cesarean delivery. Routinely formalin fixed paraffin embedded myometrial tissue will then be used for immunohistochemistry using commercially available antibodies to evaluate myometrial oxytocin receptor density (using manufacturers’ instructions) in 10 out of 30 patients from each cohort. Other Observations: These will include additional indications of efficacy of oxytocin, associated side effects and patients characteristics. |