| 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
|
|
|
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) |