| CTRI Number |
CTRI/2022/11/047511 [Registered on: 22/11/2022] Trial Registered Prospectively |
| Last Modified On: |
04/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare the patient reported outcomes with the use of oral dydrogesterone vs. micronized vaginal progesterone in high risk pregnancies |
|
Scientific Title of Study
|
A prospective, observational study to compare the patient reported outcomes with the use of oral dydrogesterone vs. micronized vaginal progesterone in high risk pregnancies (PERCEPT study) |
| Trial Acronym |
PERCEPT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EPL/PER/21/01,Version00,Dated 3.8.21 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjeev Khurd |
| Designation |
Director |
| Affiliation |
Khurd Infertility and IVF Centre |
| Address |
Khurd infertility and IVF Centre Belbaug Commercial Complex City Post Office Square Laxmi Road Pune
Belbaug Commercial Complex City Post Office Square Laxmi Road Pune
Pune
MAHARASHTRA
411002
India |
| Phone |
|
| Fax |
|
| Email |
sanjeevkhurd@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeev Khurd |
| Designation |
Director |
| Affiliation |
Khurd Infertility and IVF Centre |
| Address |
Khurd infertility and IVF Centre Belbaug Commercial Complex City Post Office Square Laxmi Road Pune
Belbaug Commercial Complex City Post Office Square Laxmi Road Pune
Pune
MAHARASHTRA
411002
India |
| Phone |
|
| Fax |
|
| Email |
sanjeevkhurd@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjeev Khurd |
| Designation |
Director |
| Affiliation |
Khurd Infertility and IVF Centre |
| Address |
Khurd infertility and IVF Centre Belbaug Commercial Complex City Post Office Square Laxmi Road Pune
Belbaug Commercial Complex City Post Office Square Laxmi Road Pune
Pune
MAHARASHTRA
411002
India |
| Phone |
|
| Fax |
|
| Email |
sanjeevkhurd@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Emcure Pharmaceuticals Ltd, Rajiv Gandhi IT Park, MIDC, Hinjawadi, Pune - 411057 |
|
|
Primary Sponsor
|
| Name |
Emcure Pharmaceuticals Ltd |
| Address |
Rajiv Gandhi IT Park, MIDC, Hinjawadi, Pune |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjeev Khurd |
Khurd infertility and IVF Centre |
Department of Obstetrics Gynecology and Infertility
Pune
MAHARASHTRA |
8007041333
sanjeevkhurd@yahoo.com |
| Dr Neelam Ohri |
New Life Hospital |
Department of Obstetrics and Gynecology
Varanasi
UTTAR PRADESH |
9415201293
drneelamohri@gmail.com |
| Dr Bhavin Khambati |
Pragati Multispeciality Hospital |
Department of Obstetrics and Gynecology
Mumbai (Suburban)
MAHARASHTRA |
9619249820
bhavinkhambati84@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Sangini Hospital Ethics Commitee, Ahmedabad for Dr. Bhavin Khambati, Mumbai |
Approved |
| Sangini Hospital Ethics Commitee, Ahmedabad for Dr. Neelam Ohri |
Approved |
| Sangini Hospital Ethics Commitee, Ahmedabad for Dr. Sajeev Khurd |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1.Pregnant women with age of ≥ 18 years and who are ready to give informed consent for participation in the study.
2.Women with clinically diagnosed pregnancy of ≤ 12 weeks of gestation and visiting department of obstetrics and gynecology.
3.History of more than two miscarriages and/or presenting with vaginal bleeding
4.Patient suitable for treatment with micronized vaginal progesterone or dydrogesterone therapy based on locally approved prescribing information. |
|
| ExclusionCriteria |
| Details |
1.Pregnant women who have contraindications for use of micronized vaginal progesterone or dydrogesterone.
2.Any condition that, in the opinion of the investigator, does not justify the patient’s inclusion in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Patient reported adverse events:
o Vulvovaginal symptoms reported: vaginal itching, irritation, burning, discharge and others.
o Other adverse events reported: Nausea, vomiting, abdominal cramps, gastritis, diarrhoea, constipation headache, fatigue, breast pain or tenderness, muscle, joint or bone pain and others.
2.Patient experience with the study medication |
Week 4 and Week 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Treatment compliance |
Week 4 and Week 8 |
| Utilization pattern: Dose prescribed, Dosing frequency, Duration of treatment |
Week 4 and Week 8 |
| Percentage of patients lost to follow up |
Week 4 and Week 8 |
| Percentage of patients switched to other treatment (other type of progesterone) |
Week 4 and Week 8 |
| Other measures: Obstetric History, Risk factor(s), Co-prescribed Medication(s) |
Week 4 and Week 8 |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
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)
|
01/12/2022 |
| 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
|
The objective of
the study is to compare oral dydrogesterone vs. micronized vaginal progesterone
in high risk pregnancies in terms of patient reported outcomes, treatment
compliance, proportion of patients switched to other treatment during the study
period and to understand the utilization pattern.
The outcome
variables like treatment details, patient reported adverse events, patient
experience and treatment compliance will be recorded at week 4 and week 8. Data
from the CRFs will be entered in a Microsoft Excel Sheet and analyzed.
Intention to treat analysis approach will be followed. Descriptive statistics
will be calculated. Categorical data will be represented in frequencies,
percentages. Quantitative data will be described as Mean ± SD. Data within the
group at more than 2 time intervals will be compared using Repeated measures
ANOVA (for normally distributed data) or Friedman’s test (for data which is not
normally distributed), followed by pairwise comparisons for significant
differences. The level of significance in the study will be < 0.05 and 95%
confidence intervals will be used to assess its significance |