| CTRI Number |
CTRI/2025/07/090226 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study of oral vs vaginal natural micronized progesterone in management of preterm labour. |
|
Scientific Title of Study
|
Comparative study of oral vs vaginal natural micronized progesterone in management of preterm labour |
| 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 kriti vardani |
| Designation |
Postgraduate resident |
| Affiliation |
Varun Arjun medical college and rohilkhand hospital banthra Shahjahanpur |
| Address |
Department of obstetrics and gynaecology ,Varun Arjun medical college and rohilkhand hospital ,banthra , Shahjahanpur , Uttar Pradesh
Department of obstetrics and gynaecology ,Varun Arjun medical college and rohilkhand hospital , Banthara, Shahjahanpur, Uttar Pradesh,242307
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9511481415 |
| Fax |
|
| Email |
Kritee1090@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran Dabholkar |
| Designation |
Professor |
| Affiliation |
Varun Arjun medical college and rohilkhand hospital banthra Shahjahanpur |
| Address |
Faculty quarters B 41 ground floor Varun Arjun medical college and rohilkhand hospital banthra Shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9167008017 |
| Fax |
|
| Email |
explain4you@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiran Dabholkar |
| Designation |
Professor |
| Affiliation |
Varun Arjun medical college and rohilkhand hospital banthra Shahjahanpur |
| Address |
Faculty quarters B 41 ground floor Varun Arjun medical college and rohilkhand hospital banthra Shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9167008017 |
| Fax |
|
| Email |
explain4you@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Obstetrics and Gynaecology , Varun Arjun Medical College and Rohilkhand Hospital ,banthra ,Shahjahanpur , India, 242307 |
|
|
Primary Sponsor
|
| Name |
Dr kriti vardani |
| Address |
Department of obstetrics and gynaecology, Varun Arjun medical college and rohilkhand hospital , banthra , Shahjahanpur ,India ,242307 |
| Type of Sponsor |
Other [Self] |
|
|
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 kriti vardani |
Varun Arjun medical college and rohilkhand hospital banthra Shahjahanpur |
Department of obstetrics and gynaecology Varun Arjun medical college and rohilkhand hospital banthra Shahjahanpur
Shahjahanpur
UTTAR PRADESH |
9511481415
Kritee1090@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Varun Arun Medical College Banthara Shahjahanpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O601||Preterm labor with preterm delivery, (2) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral natural micronized progesterone 200 mg 12 hourly versus vaginal natural micronized progesterone 200 mg 12 hourly till 37 weeks of pregnancy in preventing preterm labour. |
50 antenatal patients will be given oral natural micronized progesterone 200 mg 12 hourly and 50 antenatal patient will be given vaginal micronized progesterone 200 mg 12 hourly till 37 weeks of pregnancy.A comparison will be done based on prevention of preterm labour in both the intervention. |
| Intervention |
Oral natural micronized progesterone 200mg 12 hourly vs vaginal natural micronized progesterone 200mg 12 hourly till 37 weeks of pregnancy. |
50 antenatal patients will be given oral natural micronized progesterone 200mg 12 hourly and 50 antenatal patients will be given vaginal natural micronized progesterone 200 mg 12 hourly till 37 weeks of pregnancy. Comparison of the efficacy of both routes will be studied in the management of preterm labour. |
| Intervention |
Oral natural micronized progesterone 200mg 12 hourly vs vaginal natural micronized progesterone 200mg 12 hourly till 37 weeks of pregnancy. |
50 antenatal patients will be given oral natural micronized progesterone 200 mg 12 hourly and 50 antenatal patient will be given vaginal micronized progesterone 200 mg 12 hourly till 37 weeks of pregnancy.A comparison will be done based on prevention of preterm labour in both the intervention. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women aged eighteen to forty years. History of spontaneous preterm birth. Live singleton pregnancy. |
|
| ExclusionCriteria |
| Details |
Allergic to progesterone therapy. Refusal of patient to provide informed written consent. Known fetal anomalies. Multiple pregnancy. Prior progesterone treatment during current pregnancy. Suspected chorioamnionitis. Intrauterine fetal demise. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of patients who landed up in preterm labour. |
At 37 weeks , 40 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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)
|
15/07/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
A comparative study of oral vs vaginal natural micronized progesterone in management of preterm labour in patients visiting antenatal clinic of outpatient department in obstetrics and gynaecology Varun Arjun medical College and rohilkhand hospital ,banthra Shahjahanpur, India. We will look for patients who will land up in preterm labour even after progesterone injections. |