| CTRI Number |
CTRI/2025/08/093030 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Novel Surgical technique to Control Post Partum Hemorrhage in cases of Placenta Accreta Spectrum (PAS): A Multicenter Clinical Study |
|
Scientific Title of Study
|
Novel technique to control PPH and conserve the uterus is cases of Placenta Accreta Spectrum (PAS) disorder - A prospective interventional study |
| Trial Acronym |
PASCARE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahesh Gupta |
| Designation |
Principal Investigator |
| Affiliation |
Pushpam Upvan Prasutigurh |
| Address |
Department of Obstetrics & Gynecology
Pushpam Upvan Prasutigurh,
108-112, 1st Floor, B wing, Upvan Comm. Center, Nr. Dhartinagar Bunglow, Tragad Road, Chandkheda,
Ahmedabad-382424
Ahmadabad
GUJARAT
382424
India |
| Phone |
9426499922 |
| Fax |
|
| Email |
pushpamgynec@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Gupta |
| Designation |
Principal Investigator |
| Affiliation |
Pushpam Upvan Prasutigurh |
| Address |
Department of Obstetrics & Gynecology
Pushpam Upvan Prasutigurh,
108-112, 1st Floor, B wing, Upvan Comm. Center, Nr. Dhartinagar Bunglow, Tragad Road, Chandkheda,
Ahmedabad-382424
Ahmadabad
GUJARAT
382424
India |
| Phone |
9426499922 |
| Fax |
|
| Email |
pushpamgynec@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh Gupta |
| Designation |
Principal Investigator |
| Affiliation |
Pushpam Upvan Prasutigurh |
| Address |
Department of Obstetrics & Gynecology
Pushpam Upvan Prasutigurh,
108-112, 1st Floor, B wing, Upvan Comm. Center, Nr. Dhartinagar Bunglow, Tragad Road, Chandkheda,
Ahmedabad-382424
Ahmadabad
GUJARAT
382424
India |
| Phone |
9426499922 |
| Fax |
|
| Email |
pushpamgynec@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Matis Multispeciality Hospital, Ahmedabad, Gujarat |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
na |
| Type of Sponsor |
Other [NA] |
|
|
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 Mahesh Gupta |
Matis Multispeciality Hospital |
Room No 201 to 210,
Department of Obstetrics & Gynecology,
Opposite Adani CNG Gas Station Near Motera BRTS Bus Stop, Cross Roads, Motera, Ahmedabad, Gujarat 380005
Ahmadabad
GUJARAT |
09426499922
pushpamgynec@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shakti Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O432||Morbidly adherent placenta, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not applicable |
| Intervention |
Surgical Technique to control Post Partum Hemorrhage in cases of Placenta Accreta Spectrum Disorder |
Systematic devascularisation of Uterus.
Various Compression suture techniques to control bleeding from placental bed |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Age Criteria: Female of Child bearing age group from 18 years to 45 years
2. Patients with antenatal diagnosis of Placenta Previa
3. Patients with antenatal diagnosis or suspected case of PAS disorder
4. Patients with intra operative diagnosis of PAS disorder
|
|
| ExclusionCriteria |
| Details |
1. Patient with Blood coagulopathy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of PPH after surgical intervention |
1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Rate of Cesarean Hysterectomy
|
1 day |
| Estimation of blood loss during intervention |
1 day |
| Feto-Maternal outcome |
7 days |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
25/08/2025 |
| 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 - 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 - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- 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 - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [pushpamgynec@yahoo.com].
- For how long will this data be available start date provided 01-08-2026 and end date provided 31-07-2031?
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
|
Protocol Summary – PAS001 Title A Multicentric Open Label Prospective Interventional Study to Evaluate the Efficacy of a Novel Surgical Technique to Control PPH and Conserve the Uterus in Cases of Placenta Accreta Spectrum PAS Disorder
Protocol ID PAS001 Study Design Prospective multicenter open label interventional study Study Sites
Pushpam Hospital Sabarmati Ahmedabad
Pushpam Upvan Prasutigurh Tragad Ahmedabad
Matis Multispeciality Hospital Motera Ahmedabad
Investigators Dr Mahesh Gupta Dr Rutul Kapadia Dr Usha Gupta
Background and Rationale Placenta Accreta Spectrum PAS disorders are rising due to increasing cesarean deliveries. Conventional management often involves peripartum hysterectomy resulting in high maternal morbidity and loss of fertility. To address this the study proposes a novel conservative surgical technique aimed at controlling postpartum hemorrhage PPH and preserving the uterus in PAS cases.
Aim To evaluate the efficacy of a novel surgical technique in reducing maternal morbidity and mortality by preventing PPH and avoiding hysterectomy in PAS disorders.
Objectives Primary Objectives
Prevent PPH in PAS cases
Conserve the uterus during surgical management
Secondary Objectives
Quantify intraoperative blood loss
Assess maternal and fetal outcomes
Study Population 20 pregnant women aged 18 to 45 years with antenatal or intraoperative diagnosis of PAS meeting inclusion criteria will be enrolled from the three study sites over one year.
Methodology Overview Participants undergoing cesarean delivery will be assessed using a structured surgical approach that includes uterine exteriorization with placenta in situ application of a uterine tourniquet Foleys catheter stepwise arterial ligation and tailored myometrial suturing to achieve hemostasis. Intraoperative blood loss will be measured and postoperative recovery will be monitored.
Key Outcomes Primary Outcomes
Rate of uterine preservation
Incidence of PPH requiring hysterectomy
Secondary Outcomes
Volume of intraoperative blood loss
Maternal complications
Fetal outcomes Apgar score NICU admission
Significance This study introduces a potentially safer uterus sparing surgical technique for PAS cases. If effective it may serve as a practical alternative to radical hysterectomy preserving fertility and reducing maternal risk. |