| CTRI Number |
CTRI/2025/09/095456 [Registered on: 29/09/2025] Trial Registered Prospectively |
| Last Modified On: |
27/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The Study Aims To Determine The Use Of Chitosan Covered Gauze For Prevention Of Post Partum Hemorrhage ( Bleeding After Delivery) In Women At High Risk Of Uterine Atony. |
|
Scientific Title of Study
|
A Comparative Study Of Chitosan Covered Gauze With Intramuscular Oxytocin Versus Intramuscular Oxytocin For Prevention Of Atonic Postpartum Hemorrhage In Women With Risk Of Uterine Atony. |
| 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 Nikita Arali |
| Designation |
Junior Resident |
| Affiliation |
Shri B M Patil Deemed To Be University. |
| Address |
Obg Opd 2 ,
Shri. B M Patil Deemed To Be University,Medical College And Research Centre.
Bangaramma Sajjan Campus ,Solapur Road,Vijayapura
Obg Opd 2 ,
Shri. B M Patil Deemed To Be University,Medical College And Research Centre.
Bangaramma Sajjan Campus ,Solapur Road,Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9113960727 |
| Fax |
|
| Email |
aralinikita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajasri G Yaliwal |
| Designation |
Professor |
| Affiliation |
Shri B M Patil Deemed To Be University |
| Address |
Obg Opd 2 ,
Shri. B M Patil Deemed To Be University,Medical College And Research Centre.
Bangaramma Sajjan Campus ,Solapur Road,Vijayapura
Obg Opd 2 ,
Shri. B M Patil Deemed To Be University,Medical College And Research Centre.
Bangaramma Sajjan Campus ,Solapur Road,Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9845152240 |
| Fax |
|
| Email |
ryaliwal@bldedu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikita Arali |
| Designation |
Junior Resident |
| Affiliation |
Shri B M Patil Deemed To Be University |
| Address |
Obg Opd 2 ,
Shri. B M Patil Deemed To Be University,Medical College And Research Centre.
Bangaramma Sajjan Campus ,Solapur Road,Vijayapura
Obg Opd 2 ,
Shri. B M Patil Deemed To Be University,Medical College And Research Centre.
Bangaramma Sajjan Campus ,Solapur Road,Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9113960727 |
| Fax |
|
| Email |
aralinikita@gmail.com |
|
|
Source of Monetary or Material Support
|
| BLDE (DU) Shri BM PATIL MEDICAL COLLEGE ,HOSPITAL AND RESEARCH CENTRE,VIJAYAPURA,KARNATAKA,INDIA
586103 |
|
|
Primary Sponsor
|
| Name |
BLDEDU Shri Bm Patil medical college Hospital and Research Center |
| Address |
Obg Opd 2 ,
Shri. B M Patil Deemed To Be University,Medical College And Research Centre.
Bangaramma Sajjan Campus ,Solapur Road,Vijayapura
586103 |
| Type of Sponsor |
Private medical college |
|
|
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 Nikita Arali |
BLDE (DU) Shri B M Patil medical college ,hospital and research centre |
Obg Opd 2 ,
Shri. B M Patil Deemed To Be University,Medical College And Research Centre.
Bangaramma Sajjan Campus ,Solapur Road,Vijayapura
586103
Bijapur
KARNATAKA |
9113960727
aralinikita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituional Ethical Commiitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O098||Supervision of other high risk pregnancies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Use Of Chitosan Coated Gauze For Pevention Of Post Partum Hemorrhage In Risk Of Pregnancies With Uterine Atony. |
The Chitosan coated gauze is packed within uterus after vaginal delivery along with administration of 10 units of oxytocin Intramuscular injection given within one minute of delivery for high-risk women prone to PPH. |
| Comparator Agent |
Use Of Intramuscular Oxytocin In Risk Of Pregnancies With Risk Of Uterine Atony. |
10 units of oxytocin Intramuscular injection will be given to high-risk women prone to PPH .
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Delivering viable babies with high-risk pregnancies who are prone to Postpartum haemorrhage.
Maternal age of more than 18 years
Grand multipara
Hydramnios
Hypertensive disorders of pregnancy
Eclampsia
Gestational Diabetes Mellitus
Abruption
Anemia
Multiple gestation
Prolonged labour
|
|
| ExclusionCriteria |
| Details |
The use of Chitosan gauze only for vaginal lacerations.
Patients undergoing caesarean section.
Patients with Traumatic PPH.
Adherant or retained placenta.
Anamolous uterus.
Suspected chorioamniotis.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the blood loss during vaginal delivery when Chitosan coated gauze for prevention of of postpartum haemorrhage is used along with IM oxytocin in comparision to IM oxytocin alone |
The amount of blood loss in PPH with and without application of uterine chitosan gauze in high-risk women is measured using brass vaginal drapes, weighing wet gauzes and clots. (1gm=1mL)
Any other additional intervention or information, pharmacological or surgical are noted. Pre delivery and post delivery(after 72 hours ) Hemoglobin shall be recorded and difference noted.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the need for additional uterotonic drugs.
To assess the need for surgical intervention
|
|
To asses the need for additional uterotonic drugs.
To assess the need for surgical intervention. |
. Pre delivery and post delivery(after 72 hours ) Hemoglobin shall be recorded and difference noted. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/10/2025 |
| 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 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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [aralinikita@gmail.com].
- For how long will this data be available start date provided 15-09-2025 and end date provided 15-04-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Uterine packing with a chitosan-covered tamponade is an emerging tool in the armamentarium of the obstetrical team, especially when resources for advance surgical and other invasive options may be limited and in pregnant women with risk of uterine atony. Patients will be selected for the study based on inclusion and exclusion criteria and randomised into two groups. • Group 1-The Chitosan coated gauze is packed within uterus after vaginal dlivery along with administration of 10 units of oxytocin Intramuscular injection given within one minute of delivery for high-risk women prone to PPH. • Group 2- 10 units of oxytocin Intramuscular injection will be given to high-risk women prone to PPH . The amount of blood loss in PPH with and without application of uterine chitosan gauze in high-risk women is measured using brass vaginal drapes, weighing wet gauzes and clots. (1gm=1mL) Any other additional intervention or information, pharmacological or surgical are noted. Pre delivery and post delivery(after 72 hours ) Hemoglobin shall be recorded and difference noted. |