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CTRI Number  CTRI/2022/05/042469 [Registered on: 11/05/2022] Trial Registered Prospectively
Last Modified On: 17/01/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Safe dose of oxytocin to control excessive bleeding from uterus during cesarean section in patients with body weight above normal 
Scientific Title of Study   ED90 of Prophylactic Oxytocin Infusion During Cesarean Delivery in Non-laboring Obese vs. Non-Obese Patients: An Up-Down Sequential Allocation Dose- Response Study 
Trial Acronym  None 
Secondary IDs if Any  
Secondary ID  Identifier 
Not applicable  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Asha Tyagi 
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, Dilshad Garden, Shahadra

East
DELHI
110095
India 
Phone    
Fax    
Email  drashatyagi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Asha Tyagi 
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, Dilshad Garden, Shahadra

East
DELHI
110095
India 
Phone    
Fax    
Email  drashatyagi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Asha Tyagi 
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, Dilshad Garden, Shahadra

East
DELHI
110095
India 
Phone    
Fax    
Email  drashatyagi@gmail.com  
 
Source of Monetary or Material Support  
University College of Medical Sciences and GTB Hospital Dilshad Garden, Shahdra, Delhi, 110095 
 
Primary Sponsor  
Name  UCMS and GTBH 
Address  Dilshad Garden, Shahadra, Delhi-110095 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Asha Tyagi  University College of Medical Sciences and GTB Hospital  Department of Anaesthesiology and Critical Care, Dilshad Garden, Shahadra
East
DELHI 		 011-22692415

drashatyagi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-HR of University College of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O754||Other complications of obstetric surgery and procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  In Non-laboring Obese Patients: Titrated dose of intravenous oxytocin infusion  The dose of the infusion will be 13IU/h(0.22IU/min) for the first patient.Dosing interval (increase) for unsatisfactory response will be 2U/h.Duration will be from cord clamping to end of surgery 
Intervention  In Non-laboring Obese patients: Titrated dose of intravenous oxytocin infusion  The dose of the infusion will be 13IU/h(0.22IU/min) for the first patient.Dosing interval (increase) for unsatisfactory response will be 2U/h.Duration will be from cord clamping to end of surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  All non-laboring parturient >18 years age will be enrolled. The two arms will include obese (body mass index ≥30 kg/m2) or non-obese pregnant patients (body mass index < 30 kg/m2) posted for cesarean section under spinal anesthesia.

 
 
ExclusionCriteria 
Details  Exclusion criteria shall be patient refusal, presence of labor (defined as cervical dilatation of 3 cm or more), use of oxytocin in the preoperative period, history of PPH or more than one previous uterine surgery as well as bleeding disorders, presence of abnormal placentation and uterine fibroid, contraindications to spinal block, such as hemodynamic instability, infection at the injection site, and coagulopathy (thrombocytopenia with platelet count<100,000/mm3 or INR>1.5).

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The calculated ED90 of prophylactic oxytocin infusion in both cohorts  The status of uterine tone assessed by the operating obstetrician ( satisfactory or unsatisfactory) at 4-minute post oxytocin intiation. 
 
Secondary Outcome  
Outcome  TimePoints 
The requirement of additional uterotonic drugs.  From cord clamping to end of surgery. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   N/A 
Date of First Enrollment (India)   16/05/2022 
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="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drashatyagi@gmail.com].

  6. For how long will this data be available start date provided 28-02-2024 and end date provided 28-01-2029?
    Response (Others) -  5 YEARS AFTER COMPLETION OF PATIENT ENROLLMENT

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Introduction: Postpartum hemorrhage (PPH) is a major cause of maternal morbidity and mortality.The commonest cause of PPH is uterine atony. We plan to evaluate the minimum effective dose of oxytocin infusion for adequate uterine tone during cesarean section in non-laboring obese patients, and compare it with a control group of non-obese patients. Herein, the ED90 dose will be taken to represent the “minimum effective dose”. 
Non-laboring patients scheduled for caesarean section under spinal block will be included. Those with body mass index ≥30 kg/m2 will be included as “obese” and those with <30 kg/m2 as “non-obese” cohort. 
The anaesthetic management for both the groups will be standardized as per routine practice. Oxytocin infusion will be initiated upon clamping of the umbilical cord, in the first patient of each group (Obese and non-obese).
The dose of the infusion will be 13 IU/h (i.e., 0.22 IU/min) for the first patient in both cohorts (obese vs. non-obese controls). The uterine tone will be assessed and graded as satisfactory or unsatisfactory by the obstetrician, 4 minutes after the initiation of the oxytocin infusion. If uterine tone is deemed satisfactory with designated dose of oxytocin, the dose will be categorized as a “success”, and the infusion will be continued till end of surgery at same rate. In case of an unsatisfactory uterine tone, the dose will be considered as a “failure” and the infusion rate doubled in the particular patient (not greater than 36 IU/h). If uterine tone does not improve after another 3- to 6-minute period, an additional uterotonic agent as well as uterine massage will be administered.
The dose in subsequent cases for both cohorts will be decided by the response to oxytocin in previous patient of particular cohort. After a “failed” dose of oxytocin, the next patient of the cohort will receive an infusion rate increased by 2 IU/h. In case of a “successful” dose, the next subject’s infusion rate will be determined via a biased allocation method with 90% chance to maintain the same infusion rate and a 10% chance to decrease the infusion rate by 2 IU/h. This method of biased allocation will be determined by drawing black and white marbles (ratio 1:9) out of an opaque bag. The allocation assignments will be concealed in sequentially numbered opaque envelopes by an investigator not involved in the clinical care of the patient.
 
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