| CTRI Number |
CTRI/2020/10/028244 [Registered on: 06/10/2020] Trial Registered Prospectively |
| Last Modified On: |
29/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs
Dydrogesterone and micronized progesterone in pregnant women with threatened abortion
|
|
Scientific Title of Study
|
Comparison of oral Dydrogesterone and oral Micronized progesterone in reducing the risk of miscarriage in pregnant women with threatened abortion.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chinthala Sai Charishma |
| Designation |
postgraduate |
| Affiliation |
maulana azad medical college |
| Address |
Department of Obstetrics and Gynaecology, room number 216,loknayak resident doctors hostel, maulana azad medical college
Gudiwada Krishna District 521301 andrapradesh
New Delhi
DELHI
110002
India |
| Phone |
9640319297 |
| Fax |
|
| Email |
saicharishma1544@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishna agarwal |
| Designation |
Professor |
| Affiliation |
loknayak hospital |
| Address |
Dept of Obstetrics & Gynecology
Maulana Azad Medical College, New Delhi, India
New Delhi
DELHI
110002
India |
| Phone |
9871214208 |
| Fax |
|
| Email |
drkrishna.agarwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chinthala sai charishma |
| Designation |
postgraduate |
| Affiliation |
loknayak hospital |
| Address |
Dept of Obstetrics & Gynecology
Maulana Azad Medical College, New Delhi, India
New Delhi
DELHI
110002
India |
| Phone |
9640319297 |
| Fax |
|
| Email |
saicharishma1544@gmail.com |
|
|
Source of Monetary or Material Support
|
| loknayak hospital, maulana azad medical college |
|
|
Primary Sponsor
|
| Name |
department of Obstetrics and gynaecology |
| Address |
loknayak hospital maulana azad medical college |
| Type of Sponsor |
Government 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 |
| chinthala sai charishma |
Maulana Azad Medical College and Associated Lok Nayak Hospital |
department of Obstetrics and Gynaecology
New Delhi
DELHI |
9640319297
saicharishma1544@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O200||Threatened abortion, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dydrogesterone, duphaston |
40mg stat followed by 10mg BD till 14 weeks of gestation |
| Comparator Agent |
progesterone, susten |
200mg BD till 14 weeks of gestation |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Gestational age less than 12weeks of gestation in women with threatened abortion.
Singleton intrauterine live pregnancy.
Women aged from 20 to 35 years.
|
|
| ExclusionCriteria |
| Details |
History of recurrent miscarriage (defined as at least three consecutive spontaneous miscarriages).
History of cervical surgery.
Heavy vaginal bleeding requiring surgical intervention.
Any uterine anomalies.
Any associated medical and surgical illness. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Miscarriage before 20 weeks of gestation |
Miscarriage rate, time points :20 weeks of gestation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Live birth rate
Period of gestational age at delivery
Birth weight at delivery
Antepartum haemorrhage
Pre-eclampsia
|
20weeks to till delivery |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
12/10/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
this is a randomised, parallel group trial that compares the effectiveness between dydrogesterone and micronized progesterone in prevention of miscarriage in threatened abortion women. The primary outcome measured is miscarriage rate at 20 weeks and secondary outcomes are birth weight, period of gestation at delivery, pre eclampsia, antepartum haemorrhage, live birth rate. |