| CTRI Number |
CTRI/2024/06/068990 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
15/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Safety and Use of Dydrogesterone in Women with Repeated Miscarriages or Pregnancy Complications |
|
Scientific Title of Study
|
A cross-sectional analysis to assess the safety and Utilization of dydrogesterone in Patients with bad obstetRIc hiStory or habitual abortion in rEal world outpatients of India |
| Trial Acronym |
UPRISE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krupa Shah |
| Designation |
Principal Investigator |
| Affiliation |
Ayuh Fertility Centre |
| Address |
Ayuh Fertility Centre,
SF-201,202,Shivalik Square, 132 Ft Ring Road,
Nava Wadaj
Ahmadabad
GUJARAT
380013
India |
| Phone |
7948983895 |
| Fax |
|
| Email |
ayuhfertilitycentre@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krupa Shah |
| Designation |
Principal Investigator |
| Affiliation |
Ayuh Fertility Centre |
| Address |
Ayuh Fertility Centre,
SF-201,202,Shivalik Square, 132 Ft Ring Road,
Nava Wadaj
Ahmadabad
GUJARAT
380013
India |
| Phone |
7948983895 |
| Fax |
|
| Email |
ayuhfertilitycentre@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishnaprasad K |
| Designation |
General Manager - Medical Strategic Affairs (India,RoW) |
| Affiliation |
Torrent Pharmaceuticals Ltd. |
| Address |
Torrent Pharmaceuticals Ltd.,
Torrent House,
Ashram Road - Navrangpura,
Ahmedabad
Ahmadabad
GUJARAT
380009
India |
| Phone |
7069000572 |
| Fax |
|
| Email |
krishnaprasadkorukonda@torrentpharma.com |
|
|
Source of Monetary or Material Support
|
| Torrent Pharmaceuticals Ltd., Ashram Road - Navrangpura, Ahmedabad, GUJARAT-380009, India |
|
|
Primary Sponsor
|
| Name |
Torrent Pharmaceuticals Ltd |
| Address |
Torrent Pharmaceuticals Ltd.,
Torrent House,
Ashram Road, Navrangpura,
Ahmedabad 380009 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Krupa Shah |
Ayuh Fertility Centre |
SF-201,202,Shivalik Square, 132 Ft Ring Road
Nava Wadaj
Ahmadabad
GUJARAT |
7948983895
ayuhfertilitycentre@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sangini Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O092||Supervision of pregnancy with other poor reproductive or obstetric history, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
1. Pregnant women up to 12 weeks of gestation
2. Women with a history of miscarriage with suspect luteal phase insufficiency
3. Patients willing for follow-up at scheduled visit as per protocol at same center |
|
| ExclusionCriteria |
| Details |
1. Known hypersensitivity or contraindication to study drug
2. Heavy vaginal bleeding requiring surgical intervention.
3. Any uterine anomalies.
4. Any associated medical and surgical illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ongoing pregnancy rate (fetal viability confirmed with ultrasound) |
At 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient acceptability to treatment |
At 4 weeks |
| Safety assessment for Common Adverse events |
At 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="2000"
Sample Size from India="2000"
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)
|
26/06/2024 |
| 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="0"
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 - NO
|
|
Brief Summary
|
- This study is planned to evaluate the safety and effectiveness of dydrogesterone in Indian patients with bad obstetric history.
- Study design: Post Approval Observational Studies (PAOS).
- Duration of Observation: 12 weeks (At least)
- Study drug and dose: Dydrogesterone 10 mg
|