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CTRI Number  CTRI/2024/03/064554 [Registered on: 20/03/2024] Trial Registered Prospectively
Last Modified On: 08/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of combination of Oxytocin and Misoprostol and Oxytocin alone in third stage of labor of emergency caesarean delivery  
Scientific Title of Study   Comparison of the efficacy of a combination of Intramuscular Oxytocin (10 IU) and Sublingual Misoprostol(600mcg) with Intramuscular Oxytocin alone for Active Management of the Third Stage of Labour following Singleton Emergency Caesarean delivery - A Randomised, Double-blinded, Placebo-Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vijayalakshmi k 
Designation  Junior resident  
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research  
Address  Obstetrics and Gynaecology department JIPMER Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  8056760179  
Fax    
Email  Vijayalakshmikaruppaiah04@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  T Parvathi  
Designation  Associate Professor  
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research  
Address  Obstetrics and Gynaecology Department JIPMER Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9566537193  
Fax    
Email  Parvathinaik1@gmail.com  
 
Details of Contact Person
Public Query  
Name  T Parvathi  
Designation  Associate Professor  
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research  
Address  Obstetrics and Gynaecology Department JIPMER Pondicherry


PONDICHERRY
605006
India 
Phone  9566537193  
Fax    
Email  Parvathinaik1@gmail.com  
 
Source of Monetary or Material Support  
Intramural Research Fund, Jawaharlal Institute of Medical Education and Research Dhanvantari Nagar Pondicherry 605006 
 
Primary Sponsor  
Name  Jawaharlal Institute of Medical Education and Research  
Address  Jawaharlal Institute of Medical Education and Research Pondicherry 605006 
Type of Sponsor  Research institution and hospital 
 
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 
DrVijayalakshmi k  Jawaharlal Institute of Postgraduate Medical Education and Research   Department of obstetrics and gynaecology Women and children hospital
Pondicherry
PONDICHERRY 		 8056760179

Vijayalakshmikaruppaiah04@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Interventional Studies  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O720||Third-stage hemorrhage,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control arm - AMTSL with Injection Oxytocin 10 IU IM and Placebo sublingual   Control arm - AMTSL with Injection Oxytocin 10 IU IM and Placebo sublingual will be administered within 1 minute of delivery. Delayed cord clamping (2-3 minutes) will be done if immediate neonatal resuscitation is not warranted. The placenta and membranes will be delivered by controlled cord traction. 
Intervention  Study arm - AMTSL with Injection Oxytocin 10IU IM and Tablet Misoprostol600mcg sublingual  Study arm - AMTSL with Injection Oxytocin 10IU IM and Tablet Misoprostol600mcg sublingual will be administered within 1 minute of delivery. Delayed cord clamping (2-3 minutes) will be done if immediate neonatal resuscitation is not warranted. The placenta and membranes will be delivered by controlled cord traction. The vital signs (pulse rate, blood pressure and temperature) will be recorded intraoperatively and every 15 minutes for 1 hour following delivery or for 2 hours if bleeding continues beyond 1 hour. In case of continuous bleeding following AMTSL further intervention will be administered as per the standard protocol for the management of postpartum haemorrhage. All additional medical or surgical interventions will be recorded.After 24 hours of delivery, 2 ml blood sample will be collected for haemoglobin estimation. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Pregnant women ≥ 18 years of age
2. Gestational age ≥37 weeks to 42 weeks
3. Following singleton emergency lower segment caesarean
delivery
4. Under regional anaesthesia 
 
ExclusionCriteria 
Details  1. Antepartum haemorrhage
2. Pre-existing bleeding disorders
3. Coagulation disorders
4. Fever (greater than 38degree C)
5. Acute Gastroenteritis
6. Known hypersensitivity to Oxytocin or Misoprostol
7. Distressed due to labour pains to give informed consent
8. Liver and Renal Impairment
9. Severe Anaemia
10. On Steroid therapy  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Blood loss in ml- intraoperative and postoperative at 1 hour or 2 hours (if
bleeding continues beyond one hour) 		 Blood loss in ml- intraoperative and postoperative at 1 hour or 2 hours (if
bleeding continues beyond one hour) 
 
Secondary Outcome  
Outcome  TimePoints 
1. Need for additional uterotonics
2. Uterine massage, bimanual uterine compression
3. Duration of the third stage of labour (in minutes)
4. Surgical intervention (Balloon tamponade or compression sutures or stepwise pelvic devascularization or peripartum hysterectomy)
5. Blood transfusion
6. Severe maternal morbidity like ICU admission, Shock (shock index greater than or equal to 0.9)
7. Retained placenta requiring manual removal of placenta
8. Change in haemoglobin level (Predelivery-24 hours postpartum) (g per dl)
9. Hypotension
10. Nausea and vomiting
11. Fever (greater than or equal to 38 degree C)
12. Shivering
13. Abdominal pain
14. Diarrhoea
15. Maternal death 		 Till discharge from the hospital  
 
Target Sample Size   Total Sample Size="270"
Sample Size from India="270" 
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 
Date of First Enrollment (India)   15/04/2024 
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 Applicable 
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 - 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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [parvathinaik1@gmail.com].

  6. For how long will this data be available start date provided 01-03-2024 and end date provided 01-03-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Postpartum haemorrhage (PPH) is defined as blood loss of 1000ml or more within 24 hours following a Lower Segment Cesarean Section (LSCS). It nearly affects 5% of the women population giving birth. PPH accounts for about 1/4th of all maternal deaths and is the leading cause of the same. WHO recommendation for the prevention of PPH through Active Management of the Third Stage of Labour (AMSTL) is 10U IM or IV oxytocin immediately following delivery of the baby. In 2018, WHO recommended using oxytocin 10U (IM or IV) and misoprostol (400 or 600 micrograms) to prevent PPH for all births. Injectable prostaglandins are not recommended for preventing PPH. In the setting of oxytocin unavailability and skilled health personnel are not present to administer injectable uterotonics, the administration of Misoprostol (400 or 600 micrograms) by community and lay health workers is recommended

There is a lack of efficacy studies comparing the combination of sublingual misoprostol 600mcg and IM oxytocin 10 IU versus IM oxytocin 10 IU IM for active management of the third stage of labour for singleton emergency caesarean delivery.

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