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CTRI Number  CTRI/2024/02/063174 [Registered on: 26/02/2024] Trial Registered Prospectively
Last Modified On: 27/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparison of effect between Oral Dydrogesterone and Oral Micronized Progesterone in treating Threatened Miscarriage 
Scientific Title of Study   An Open-Label, Randomized Controlled Trial to Compare the Efficacy and Safety of Oral Dydrogesterone Versus Oral Micronized Progesterone in Treating Threatened Miscarriage and in Modulation of Immune Factors 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MC/DDB/23-013, Version 1.0 Dated 6 November 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Alka Kriplani 
Designation  Head Department, Gynaecology and Obstetrician 
Affiliation  Paras Hospitals 
Address  Paras Hospital, Dept of Gynaecology and Pediatric, Room No.11 C-1, Sushant Lok-1, Sector-43, Phase-1, Gurugram,Haryana, 122002

Gurgaon
HARYANA
122002
India 
Phone  9810828717  
Fax    
Email  kriplanialka16@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Alka Kriplani 
Designation  Head Department, Gynaecology and Obstetrician 
Affiliation  Paras Hospitals 
Address  Paras Hospital, Dept of Gynaecology and Pediatric, Room No.11 C-1, Sushant Lok-1, Sector-43, Phase-1, Gurugram,Haryana, 122002

Gurgaon
HARYANA
122002
India 
Phone  9810828717  
Fax    
Email  kriplanialka16@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Alka Kriplani 
Designation  Head Department, Gynaecology and Obstetrician 
Affiliation  Paras Hospitals 
Address  Paras Hospital, Dept of Gynaecology and Pediatric, Room No.11 C-1, Sushant Lok-1, Sector-43, Phase-1, Gurugram,Haryana, 122002

Gurgaon
HARYANA
122002
India 
Phone  9810828717  
Fax    
Email  kriplanialka16@gmail.com  
 
Source of Monetary or Material Support  
Mankind Pharma 262, Okhla Industrial Estate Phase III, New Delhi, India. 
 
Primary Sponsor  
Name  Mankind Pharma 
Address  262, Okhla Industrial Estate Phase III, New Delhi, India. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 11  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashima Taneja  Dayanand Medical College & Hospital  Dayanand Medical College & Hospital, Department of Obstetrics and Gynecology, Ludhiana, Punjab, 141001, India
Ludhiana
PUNJAB 		 9815500198

kauraashima@gmail.com 
Dr Nisha Saumil Patel   Dev Art Ivf and Shachi Womens Hospital  Dev Art Ivf and Shachi Womens Hospital , Department of Obstetrics and Gynecology, Kaveri Complex, Subhash Bridge, opp. RTO Circle, Keshav Nagar, Ranip, Ahmedabad, Gujarat 380027
Ahmadabad
GUJARAT 		 9879596512

nishadevartivf@gmail.com  
Dr Gouri Shankar Kamilya  IPGME&R and SSKM Hospital  IPGME&R and SSKM Hospital, Department of Obstetrics and Gynecology, Ground Floor, Room No. 7, 244 AJC Bose Road,Kolkata-700020 West Bengal
Kolkata
WEST BENGAL 		 9433122643

drgkamilya@gmail.com 
Dr Choudhary Shilpa Ramesh  Lifeline Medicare Hospital   Lifeline Medicare Hospital,Department of Obstetrics and Gynecology, Ground Floor,DLH Park,SV Road,Near MTNL Signal,Sunder Nagar,Goregaon West, Maharashtra : 400062
Mumbai
MAHARASHTRA 		 9820497795

drshilpchoudharycr@yahoo.com 
Dr Gayathri Karthik Nagesh  Manipal Hospital  Manipal Hospital, Department of Obstetrics and Gynecology, Floor -1, 98 Old Airport Road, Bengaluru, Karnataka, 560017
Bangalore
KARNATAKA 		 9845072208

dr.gayathrikarthik@gmail.com 
Dr Amol Pawar  Nowrosjee Wadia Maternity Hospital, Mumbai  Nowrosjee Wadia Maternity Hospital, Mumbai, Department of Obstetrics and Gynecology, Main OPD building, Ground floor, Acharya Donde Marg, Parel, Mumbai, Maharashtra,India, 400 012
Mumbai
MAHARASHTRA 		 9820610319

amolpawar@hotmail.com 
Dr Alka Kriplani  Paras Hospitals  Paras Hospitals, Dept of Gynaecology and Pediatric Department Room No.11 C-1, Sushant Lok-1, Sector-43, Phase-1, Gurugram,Haryana, 122002
Gurgaon
HARYANA 		 9810828717

kriplanialka16@gmail.com 
Dr T Ramani Devi   Ramkrishna Medical Centre LLP  Ramkrishna Medical Centre LLP, Department of Obstetrics and Gynecology, 20,21 Vivekananda Nagar, Tiruchirappalli, Tamil Nadu 620003
Tiruchirappalli
TAMIL NADU 		 9443155282

ramanidevidr@yahoo.co.in 
Dr Mrinal Kanti Dash   Sparsh Hospital & Critical Care  Sparsh Hospital & Critical Care , Department of Obstetrics and Gynecology, Back Side Of Kalyan Jewellers, A/407, Sparsh Hospital Rd, Saheed Nagar, Bhubaneswar, Odisha 751007
Baleshwar
ORISSA 		 9437960744

mkdash8@gmail.com  
Dr Tapan Kumar Pattnaik  Sum Ultimate Medicare Hospital  Sum Ultimate Medicare Hospital, Department of Obstetrics and Gynecology, Main Building, Ground Floor, K8 Kalinga Nagar, Ghatikia, Bhubaneswar, Odisha 751003
Khordha
ORISSA 		 9937550082

drtapan73@gmail.com 
Dr Tanusree Gupta  Udayan Health Care Pvt Ltd.   Udayan Health Care Pvt Ltd. Department of Obstetrics and Gynecology, 730, near Bangla Bazar, Lucknow, Uttar pradesh
Lucknow
UTTAR PRADESH 		 9956195507

dr_tanusree@yahoo.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 11  
Name of Committee  Approval Status 
Drug Trial Ethics Committee, Dayanand Medical College and Hospital  Approved 
Ethics Committee of Manipal Hospital  Approved 
IEC of New Health Care Nursing Home Address: New Health Care Nursing Home C Satellite Park Near G.C.C Club Mira Road (E) Thane Thane Maharashtra - 401107 India  Approved 
Institutional Ethics Committee Aatman Hospital, 5, Anveshan Row House, Opp Umiya Mata Mandir Bopal-Ghuma Main Road, Bopal Ahmedabad Ahmedabad Gujarat - 380058 India  Approved 
Institutional Ethics Committee, Sparsh Hospitals and Critical Care Private Limited Address: Sparsh Hospitals and Critical Care Private Limited Plot No-A/407, Saheed Nagar, Bhubaneswar Khordha, Orissa - 751007 India  Approved 
Institutional Ethics Committee, Harshamitra Superspeciality Cancer Centre  Approved 
Institutional Ethics Committee, Nowrosjee Wadia Maternity Hospital  Approved 
Institutional Ethics Committee-Clinical Research & Studies (IEC-CRS)  Approved 
IPGME&R Research Oversight Committee  Approved 
Paras Hospital Ethics Committee  Approved 
The Institutional Human EC, Udyan Health Care, 730, near Bangla Bazar, Lucknow, Uttar pradesh,   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O039||Complete or unspecified spontaneous abortion without complication,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Oral dydrogesterone  Oral dydrogesterone (40 mg STAT, followed by 10 mg TID) till a maximum of 14 weeks of gestation 
Comparator Agent  Oral micronized progesterone  Oral micronized progesterone (200 mg BID) till a maximum of 14 weeks of gestation 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  39.00 Year(s)
Gender  Female 
Details  1. Pregnant women aged 20 to 39 years with threatened miscarriage (vaginal bleeding and or abdominal pain)in the first trimester
2. Gestational age between 5 to 12 weeks
3. Euthyroidism or controlled hypothyroidism(based on medical history)
4. Presence of a viable pregnancy
5. Presence of intrauterine gestational sac on ultrasonography if a urine pregnancy test is first positive within the past 2 weeks
6. BMI between 18 and 30 kg per m2
7. Willingness to provide written informed consent
 
 
ExclusionCriteria 
Details  1. Pregnant women with inevitable abortion
2. History of recurrent miscarriage defined as at least two consecutive spontaneous miscarriages
3. Heavy vaginal bleeding or severe abdominal pain requiring surgical intervention
4. Presence of intrauterine fetus with a crown-rump length inappropriate for gestational age, with no visible heartbeat, or a mean
gestational sac of greater than equal to 25mm with no viable fetal pole in ultrasound
5. Evidence of ectopic pregnancy
6. Conceived on gonadotrophins or with the use of assisted reproductive technologies
7. Abnormalities in the structure of the uterus or amputation of the cervix, or any other genital tract anomalies
8. Uterine myoma with submucosal location of the node(a clinically significant size as judged by the Investigator)
9. Anembrion or fetal malformations as established causes of loss of previous pregnancies
10. Other clinically significant causes of miscarriage identified during
examination (including but not limited to pre-pregnancy diabetes, pre-pregnancy uncompensated thyroid dysfunction, history of malignant tumors or current tumors, or psychiatric illnesses)
11. Known Sexually Transmitted Diseases (STDs)
12. Administration of enzyme-inducing medicinal products such as (anticonvulsants, antipsychotics, antidepressants, tranquilizers), use
of psychoactive substances before and during pregnancy
13. Multiple pregnancy
14. Known as having an endocervical polyp
15. Known as having infection such as pneumonia, pyelonephritis, septicemia
16. Known as having autoimmune diseases such as systemic lupus erythematosus, systemic sclerosis, rheumatoid arthritis
17. Known as having a coagulation defect
18. Known as having severe heart, liver, lung, kidney, or other organ disorder
19. Current or ongoing substance abuse, including alcohol and tobacco, as determined by the Investigator
20. History of chemotherapy or radiotherapy
21. Known allergy or hypersensitivity to dydrogesterone or oral micronized progesterone
22. Use of hCG or dydrogesterone or progesterone within 1 month prior to study enrollment
23. Participation in any other clinical trial within 30 days prior to the study enrollment
24. Planned participation in any other trial during the entire duration of the study
25. Refusal or inability to comply with the requirements of the protocol for any reason, including scheduled clinic or hospital visits and
laboratory tests
26. Any other condition(s) which would make the patient, in the opinion of the Investigator, unsuitable for the study
27. Any other clinical condition(s) that, as judged by the Investigator, contradict(s) inclusion criteria, may lead to early termination of the subject participation in the study, or make it difficult to interpret the results obtained in the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Miscarriage rate before 20 weeks of gestation  Week5, Week6, Week8, Week10, Week12, Week14 and Week 18-20 ( Weeks of gestation) 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary endpoints
1. Ongoing pregnancy rate at 24 weeks
2. Change in serum levels of
cytokines(IL-4, IL-10, IFN-γ, & TNF-α) from baseline to end of treatment
3. Time to symptom (vaginal bleeding or abdominal pain) resolution

Safety Endpoints
4.Treatment-Emergent Adverse Events(TEAEs)
5. Changes in Complete Blood Count(CBC)
6. Change in results of Liver Function Tests (LFT) from baseline to 14 & 24-26 weeks of gestation
7. Change in results of Kidney Function Tests (KFT) from baseline to 14 & 24-26 weeks of gestation

Exploratory Endpoints


8. Rate of live birth
9. Mode of delivery
10. Gestational age & birth weight of newborn
11. Resuscitation requirements
12. Congenital anomalies in the newborn
13. History of pre-eclampsia 		 Secondary Endpoints
1. Week5,6,8,10,12,14,18-20 & 24-26
2. Week5,6,8,10,12,14,18-20 & 24-26, Post delivery
3. Week5,6,8,10,12,14,18-20 & 24-26, Post delivery
Safety Endpoints
1. Week5,6,8,10,12,14,18-20 & 24-26, Post delivery
2. Week5,6,8,10,12,14,18-20 & 24-26
3. Week5-12,14,24-26
4. Week5-12,14,24-26

Exploratory Endpoints
1. Post Delivery
2. Post Delivery
3. Post Delivery
4. Post Delivery
5. Post Delivery
6. Post Delivery

 
 
Target Sample Size   Total Sample Size="304"
Sample Size from India="304" 
Final Enrollment numbers achieved (Total)= "304"
Final Enrollment numbers achieved (India)="304" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/02/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 is an Open-Label, Randomized Controlled Trial to Compare the Efficacy and Safety of Oral Dydrogesterone Versus Oral Micronized Progesterone in Treating Threatened Miscarriage and in Modulation of Immune Factors. The primary objective is to compare the reduction in miscarriage rate before 20 weeks of gestation between pregnant women with threatened miscarriage treated with oral dydrogesterone versus oral micronized progesterone. 
Subjects satisfying all eligibility criteria will be offered intervention according to randomization till 14 weeks of gestation. The interventional medicinal products will be – Progesterone Micronized oral 200 mg two times a day (BID) or Dydrogesterone 40 mg STAT followed by 10 mg three times a day (TID) for up to 1 week after the bleeding is stopped, or till a maximum of 14 weeks of gestation, or until miscarriage is confirmed within 14 weeks of gestation. The continuation of treatment after 14 weeks of gestation will solely be at the discretion of the treating doctor. All adverse events will be recorded. Data collected at baseline and follow-up visits will be analyzed.

The study visit will be as per the following schedule:

Visit1 (screening and randomization): 5-12 weeks of gestation
Visit 2 (one week after Visit 1): 6-13 weeks of gestation*
Visit 3(two weeks after Visit 2): 8-14 weeks of gestation**
Visit4 (End of treatment visit): 14 weeks (window period: +3 days)
Visit5 (FU visit 1): 18-20 weeks
Visit6 (FU visit 2): 24-26 weeks***
Visit7 (FU visit 3): Telephonic visit post-delivery
*If Visit 2 happens at 13 weeks of gestation, then Visit 3 will be scheduled after 1 week of the same (i.e., at the 14th week)
**If Visit 3 happens before 14 weeks of gestation, the additional visits will be scheduled every 2 weeks until 14 weeks of gestation
➢ Scheduled blood/urine evaluations, and Ultrasonography:
•Visit 1 [CBC, LFT, KFT, Urine routine and culture, HVS culture sensitivity, Blood group, Rh factor, viral markers, immunomodulation markers i.e., serum levels of cytokines (IL-4, IL-10, IFN-γ, and TNF-α), dating USG/Level-1]
•Visit 2 [USG/Level-1]
•Visit 3 [USG/Level-1 or NT-NB scan#, dual marker test]
•Visit 4 [CBC, LFT, KFT, immunomodulation markers, i.e., serum levels of cytokines (IL-4, IL-10, IFN-γ, and TNF-α)]
•Visit 5 [USG/Level 2 scan]
•Visit 6 [CBC, LFT, KFT]
•Visit 7 [Telephonic visit post-delivery]
#NT-NB scan will be done at 11-13 weeks of gestation
 
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