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CTRI Number  CTRI/2025/05/086110 [Registered on: 01/05/2025] Trial Registered Prospectively
Last Modified On: 30/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To see the difference in amount of blood loss between using tablet misoprostol via rectum before surgery along with vasopressin injection on the uterus and vasopressin injection alone in women undergoing laparoscopic removal of fibroid from uterus  
Scientific Title of Study   Comparison of intraoperative blood loss with rectal misoprostol along with intramyometrial vasopressin and intramyometrial vasopressin alone in women undergoing laparoscopic myomectomy – a double blinded randomized 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  Angelin Vincy 
Designation  PG registrar, OBGYN 
Affiliation  Christian medical college, Vellore 
Address  Angelin vincy E, Department of obstetrics and gynecology, unit -1 OG1 office, department of Obstetrics and gynecology, 7th floor, ISSCC building, CMC hospital campus, Vellore, 632004
Angelin vincy E 215, LIQ, Christian medical college, vellore 632004
Vellore
TAMIL NADU
632004
India 
Phone  9791985744  
Fax  0  
Email  angelvincy97@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Smitha Jacob 
Designation  Assistant professor  
Affiliation  Christian medical college, Vellore 
Address  Department of obstetrics and gynecology, unit -1 OG1 office, department of Obstetrics and gynecology, 7th floor, ISSCC building, CMC hospital campus, Vellore, 632004
Block 62, CMC nursing college housing campus, kagithapatarai, vellore 632004
Vellore
TAMIL NADU
632004
India 
Phone  9791545341  
Fax  0  
Email  smitharony@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Angelin Vincy 
Designation  PG registrar, OBGYN 
Affiliation  Christian medical college, Vellore 
Address  Angelin vincy E, Department of obstetrics and gynecology, unit -1 OG1 office, department of Obstetrics and gynecology, 7th floor, ISSCC building, CMC hospital campus, Vellore, 632004
Angelin vincy E, 215 , LIQ ,christian medical college , Velloore , Tamilnadu 632002
Vellore
TAMIL NADU
632004
India 
Phone  9791985744  
Fax  0  
Email  angelvincy97@gmail.com  
 
Source of Monetary or Material Support  
instuition review board , christian medical college, bagayam,vellore Tamil nadu 632002 India 
 
Primary Sponsor  
Name  Internal fluid research grant 
Address  Christian medical college, office of research , istitution review board, bagayam,vellore Tamil nadu 632002 India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Institutional fluid grant   Christian medical college vellore 
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 Angelin Vincy   Christian medical college   Deparrment of gynaecology unit 1 and 2 , ISSCC building, Ida Scudder road, VELLORE 632002
Vellore
TAMIL NADU 
9791985744

angelvincy97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Christian medical college   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Misoprostol   Misoprostol 600mcg Perrectum Stat single dose prior to surgery along with inj vasopressin (10units in 100 ml NS) upto 200ml intraoperatively Single dose 
Comparator Agent  Vasopressin   Only vasopressin intraoperatively ( standard of care) 10 units in 100ml NS - maximum upto 200ml (20units) Single dose 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Women in reproductive age group (18- 45 years)
Figo type 2- 7 fibroids
Uterus size <20 weeks
Largest myoma < 15 cm 
 
ExclusionCriteria 
Details  Figo Type 0, 1 and 8 fibroid
History of bleeding disorder or patient on anticoagulation
Patient unfit for laparoscopic surgery 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary outcome:
Decrease in intraoperative blood loss
 
day 0 till day 2  
 
Secondary Outcome  
Outcome  TimePoints 
Conversion to laparotomy
Duration of surgery
Ease of enucleation 
Intraoperative findings only
Follow up at 1 week 
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
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)   01/06/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - NO
Brief Summary   Myomectomy, is indicated in symptomatic women who wish to conserve the uterus , may be performed by hysteroscopy, laparoscopy, or laparotomy, according to their size, location, number, and the experience of the surgeon. In women who wish to conserver their uterus for reproductive function or otherwise, laparoscopic myomectomy is preferable to abdominal myomectomy because it provides more rapid recovery, fewer postoperative adhesion, less blood loss, and less postoperative pain. Perioperative complications, reproductive outcomes, and risk of uterine rupture are similar to those obtained with open myomectomy. The most common complication of myomectomy is hemorrhage. Currently, during myomectomy, the myometrium overlying the fibroids is injected with a diluted solution of vasopressin (20 units in 100 mL of normal saline) as it diminishes blood flow locally and regionally at the level of the uterine arteries. 
This study is a randomized controlled study that aims to compare the use of rectal misoprostol with intramyometrial vasopressin and intramyometrial vasopressin alone in reducing the blood loss during myomectomy. Misoprostol exerts its effect on the uterus by inducing myometrial contractions and causes vasoconstriction of the uterine arteries, restricting the vascular supply and hence reducing the blood flow to the leiomyomas. It is also safe, effective and cheap. The minor side effects of Tab. Misoprostol are fever, chills, loose stools , abdominal pain, nausea , vomiting and dyspepsia.
 Patient in this study will be recruited from outpatient department and general wards under department of gynecology units 1 and 2, Christian medical college, Vellore from October 2023 to October 2025. This will be a randomized controlled trial.
The protocol will be submitted to the Institutional review board for approval. Once approved, women planned for myomectomy for symptomatic leiomyoma based on previous transvaginal ultrasound, transabdominal ultrasound or MRI will be enrolled. Based on the imaging – fibroid mapping – once the number, size and location of the fibroid is known, inclusion and exclusion criteria will be applied, and patients will be recruited for the study after informed written consent.
 The patients will be randomly allocated into 2 groups, Group 1 – Rectal misoprostol 800mcg + Intramyometrial vasopressin (n = 65 ) and Group 2 – Intramyometrial vasopressin only (n=65 ), via a computer generated randomization list. A physician not directly involved in the study will prepare the sequentially – numbered sealed envelopes, containing either group 1 or group 2, labelled A and B respectively. After the informed consents are signed, the investigator will open the envelope and the randomization will be ensured by giving the drug to the doctor assigned. Misoprostol tablets 600mcg will be administered per rectally (per rectal examination is not done, only the drug is placed per rectally) by the doctor to the patient based on the randomization, 90 minutes prior to surgery, according to the set protocol. The surgeon is blinded and unaware of which group the patients are randomized into.
 Only assigned surgeons from each unit will be performing all the myomectomies. The myometrium overlying the fibroids is injected with a diluted solution of vasopressin (1 unit/ml of saline). Once the surgery is complete, the surgeon will fill the details in the Performa regarding the blood loss and ease of enucleation. Patients will be monitored postoperatively in the recovery for minimum of 2 hours and then in the ward until discharge for any postoperative complications.
Data entry will be done using Epidata and Statistical analysis will be performed using SPSS version 25 (IBM Inc., Armonk, NY, USA)
 
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