| CTRI Number |
CTRI/2025/10/096177 [Registered on: 17/10/2025] Trial Registered Prospectively |
| Last Modified On: |
16/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
uterine artery clamp(T- clamp) to reduce blood loss in cesarean section |
|
Scientific Title of Study
|
Prophylactic application of trans abdominal uterine artery clamp immediately after delivery of baby vs standard care to reduce blood loss in cesarean section - a randomised control study in a tertiary care centre |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Sismitha B |
| Designation |
DNB Resident |
| Affiliation |
rajagiri hospital |
| Address |
Department of Obstetrics and gynaecology,
Rajagiri hospital,
Chunangamvely,
Aluva,
Kochi,
Kerala,
India- 683112.
Ernakulam
KERALA
683112
India |
| Phone |
8489138887 |
| Fax |
|
| Email |
sismithabommuraj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Soumya |
| Designation |
Senior Consultant |
| Affiliation |
Rajagiri hospital |
| Address |
Department of Obstetrics and gynaecology,
Rajagiri hospital,
Chunangamvely,
Aluva,
Kochi,
Kerala,
India- 683112.
Ernakulam
KERALA
683112
India |
| Phone |
9901319562 |
| Fax |
|
| Email |
soumyar10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Sismitha B |
| Designation |
DNB Resident |
| Affiliation |
Rajagiri hospital |
| Address |
Department of Obstetrics and gynaecology,
Rajagiri hospital,
Chunangamvely,
Aluva,
Kochi,
Kerala,
India- 683112.
Ernakulam
KERALA
683112
India |
| Phone |
9746709317 |
| Fax |
|
| Email |
sismithabommuraj@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rajagiri hospital |
| Address |
Rajagiri hospital,
Chunangamvely,
Aluva,
Kochi,
Kerala
India- 683112. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sismitha B |
Rajagiri Hospital |
Rajagiri Hospital, Chunangamvely,
Aluva, Kochi, Kerala,India - 683112
Ernakulam
KERALA |
8489138887
-
sismithabommuraj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RAJAGIRI HOSPITAL INSTITUTONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O679||Intrapartum hemorrhage, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Active Management of Third stage of labour +
Trans- abdominal uterine artery clamp (T- clamp) |
Transabdominal uterine artery clamp, is a modified shorter iteration(22.5cm) of transvaginal uterine artery clamp devised by Dr.V.P.Paily. The distal end of the blades is of length 2.5cm and width 1cm covering larger surface area. They have inner atraumatic serrations to increase the grip.
When T clamp is applied directly on the uterine arteries, it temporarily dampens flow velocities ,protects the nascent unstable clot formed in distal arterial cascades which is usually washed away by the “Trip hammer effect”, at each pulse wave and thus these vessels will resist further bleeding during the next systolic pulse wave.
It can also be used to grip the bleeders in the uterine edges. Their wider blades covers a larger surface area compared to the conventional clamp used.
All these mechanisms help to reduce blood loss in cesarean section and the morbidity associated with it.
Active Management of Third Stage of Labour - Uterotonics, controlled cord traction and massage of uterine fundus
Immedaitely after delivery of baby, Active management of third stage labour given and T-clamp applied over bilateral uterine arteries and bleeders in uterine edges before placental separation |
| Comparator Agent |
Standard care of management - Active Management of third stage of labour |
Active management of third stage of labour - uterotonic drugs immediately upon fetal delivery, controlled cord traction, and massage of the uterine fundus
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Women undergoing caesarean section(Emergency and elective
caesarean section)
Gestational age 34 weeks – 40 weeks |
|
| ExclusionCriteria |
| Details |
Women refusing to give informed consent
Placenta previa, Placenta accreta, Placental abruption
Crash Lower Segment Cesarean Section - cord prolapse, prolonged fetal bradycardia, placental abruption
Blood dyscarias |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Blood loss in cesarean section
|
Time point 1 - calculated at the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Drop in Haemoglobin cesarean section |
Time point 1- measured 24 hours preoperatively
Time point 2 - 24 hours post operatively
|
| Need of blood transfusion |
Time point 1 - intraoperatively,
Time point 2- post operatively within 48 hours |
| Need for secondary surgical interventions |
Time point 1 - intraoperatively,
Time point 2- post operatively within 48 hours |
| Incidence of surgical complications |
Time point 1 - intraoperatively,
Time point 2- post operatively within 48 hours |
|
|
Target Sample Size
|
Total Sample Size="190"
Sample Size from India="190"
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)
|
27/10/2025 |
| 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="1"
Months="6"
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 - YES
- 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).
- What additional supporting information will be shared?
Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sismithabommuraj@gmail.com].
- For how long will this data be available start date provided 19-03-2028 and end date provided 19-03-2033?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Global prevalence of cesarean section is 21.50 percentage. With increasing trend of cesarean, one of the main concern is the blood loss which is twice the amount of vaginal delivery. Bleeding associated with cesarean section has become an important cause of hemorrhage - related maternal deaths and morbidity. One third of deaths followed by cesarean section is attributed to Postpartum hemorrhage, inspite of Active management of third stage of labour, The major reasons of bleeding after delivery of fetus is Atonic PPH and Arterial bleeders from uterine tears. Usually we address this after delivery of placenta but a quick method of promptly arresting the bleeding is by clamping the bleeders on arterial bleeders on uterine edges and angles and uterine artery vessels on both sides using a T clamp without waiting for placental separation The Purpose of this study is to evaluate the efficacy of prophylactic transabdominal uterine artery clamp application immediately after delivery of baby in reducing the blood loss and incidence of Postpartum hemorrhage in cesarean section. A Randomised control study is planned to be conducted in the Department of obstetrics and gynecology, Rajagiri hospital, Aluva. Since there are no published articles regarding efficacy of Transabdominal uterine artery clamp in cesarean section, we are planning to conduct a pilot study We hypothesise that prophylactic application of Transabdominal uterine artery clamp in cesarean section immediately after delivery of baby reduces the blood loss and incidence of Postpartum hemorrhage, need for blood transfusions, need for secondary interventions, incidence of postpartum anaemia. Our study sample will be divided into two groups by simple randomization with one group receiving prophylactic transabdominal uterine artery clamp immediately after delivery and the other group receiving only the standard care. We shall compare the amount of blood loss between two groups, incidence of PPH,need of blood transfusion, incidence of anaemia at discharge, need of secondary surgical interventions, surgical complications in both groups. |