| CTRI Number |
CTRI/2024/10/075727 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
19/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Response of patient of threatened abortion to two oral forms of progesterone |
|
Scientific Title of Study
|
Comparison between Oral Dydrogesterone and Oral Micronized Progesterone in Threatened Abortion : A randomized controlled trial |
| 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 Jairath Nikki Brijbhushan |
| Designation |
Junior Resident |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
Room no 2028
Department of Obstetrics and Gynaecology
Rohilkhand Medical College and Hospital Pilibhit Bypass road
Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9665066760 |
| Fax |
|
| Email |
nikkijairath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jairath Nikki Brijbhushan |
| Designation |
Junior Resident |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
Room no 2028
Department of Obstetrics and Gynaecology
Rohilkhand Medical College and Hospital Pilibhit Bypass road
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9665066760 |
| Fax |
|
| Email |
nikkijairath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shobha Mukherjee |
| Designation |
Professor |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
Room no 2028
Department of Obstetrics and Gynaecology
Rohilkhand Medical College and Hospital Pilibhit Bypass road
Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9319854442 |
| Fax |
|
| Email |
shosa@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Rohilkhand Medical College and Hospital, Pilibhit Bypass road,
Bareilly,
UTTAR PRADESH,
243006,
India |
|
|
Primary Sponsor
|
| Name |
Rohilkhand Medical College and Hospital, Bareilly |
| Address |
Rohilkhand Medical College and Hospital, Pilibhit Bypass Road, Bareilly, Uttar Pradesh 243006, India |
| Type of Sponsor |
Private 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 |
| Dr Jairath Nikki Brijbhushan |
Rohilkhand Medical College and Hospital |
Department of Obstetrics and Gynaecology Rohilkhand Medical College and Hospital
Pilibhit Bypass Road
Bareilly
Bareilly
UTTAR PRADESH |
9665066760
nikkijairath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, RMCH, Bareilly, U.P. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O08||Pregnancy with abortive outcome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Oral Dydrogesterone |
Dydrogesterone is an exogenous synthetic progesterone that is identical to natural synthetic progesterone in structure and pharmacological actions. It doesnt exhibit androgenic (in the mother) and estrogenic (in the fetus) side effects like other synthetic progesterone in use.
Duration of intervention is 16 weeks. |
| Intervention |
Oral Micronized Progesterone |
Oral micronized progesterone is a form of natural progesterone in the form of suspension of oil. It closely mimics the natural Progesterone, solves the problem of absorption and it lacks the adverse metabolic effects of synthetic progesterone.
Duration of intervention is 16 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
All Patients presenting with the threatened abortion of age more than or equal to 18 years with a live intrauterine gestation of less than or equal to 20 weeks confirmed by Ultrasonography. |
|
| ExclusionCriteria |
| Details |
- Known parental chromosomal anomaly.
- Heavy bleeding per vaginum requiring surgical intervention.
- Known allergy to any of the two or both the drugs.
- Case of recurrent miscarriage i.e. three or more spontaneous miscarriages in the past.
- Suspected or confirmed breast or genital cancer, hepatic disease or tumour. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
- To compare Dydrogesterone and Oral Micronized Progesterone in Threatened Abortion
- To determine the efficacy and safety of Oral dydrogesterone in threatened abortion.
- To assess the efficacy and safety of Oral micronized progesterone in threatened abortion. |
Follow up visits scheduled at 7th, 14th and 21st day of prescription |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- duration and extent of bleeding
- fetomaternal outcomes.
- mode of delivery and weight of the baby for health status
- side effects during treatment |
Follow up visits scheduled at 7th, 14th and 21st day of prescription |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/11/2024 |
| 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="1"
Months="0"
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
|
Abortion can be defined as the extraction or expulsion of a foetus or an embryo weighing less than 500 grams at less than 20 weeks period of gestation (WHO and The National Centre of Health Statistics), incapable of independent survival. Abortion is a common outcome occurring in 10-15% of total clinically recognised pregnancies. It can be a devastating event for women leading to stress, depression, anxiety, delay in family completion, economic burden and hence family tension.
Of the many clinical presentations of abortion, at one end we have inevitable abortion which presents with bleeding, cervical dilatation and pain in the abdomen, indicating impending abortion and on the other we have threatened abortion where excluding genetic causes timely intervention can lead to a positive fetomaternal outcome. Threatened abortion presents with spotting per vaginum, with or without abdominal discomfort less than 20 weeks of gestation, with an alive intrauterine fetus. An important prerequisite of threatened abortion is closed internal os in per vaginum examination. Pathogenicity of threatened abortion is multifactorial such as chromosomal anomalies, structural anomalies incompatible with life, infections, uterine anomalies, uncontrolled diabetes, immunological dysfunction like APLA, endocrine factors like levels of thyroid hormone, and absence of adequate progesterone concentration. Decreased progesterone due to dysfunctional corpus luteum is one of the main reasons for threatened abortion. Hence, exogenous progesterone is prescribed as the primary treatment for threatened abortion besides bed rest.
Progesterone is a female sex hormone and as the name suggests is " Pro - Gestation" by aiding implantation, maintaining pregnancy and preventing early contractions of the uterus. Progesterone supplements are available in the form of injections, tablets, capsules and vaginal suppositories. Maximum compliance is noted in the oral route of administration. On the contrary, oral administration of natural progesterone is found less effective as it is highly lipophilic and insoluble in water. In 1980 oral micronized progesterone in the form of suspension of oil came as a boon. It solved the problem of absorption and it lacks the adverse metabolic effects of synthetic progesterone as well. Dydrogesterone is an exogenous synthetic progesterone that is identical to natural synthetic progesterone in structure and pharmacological actions. It doesn’t exhibit androgenic (in the mother) and estrogenic (in the fetus) side effects like other synthetic progestogens in use.
To prevent threatened abortions and to safeguard pregnancy, progesterone has been the choice of drug and is widely prescribed all over. Even so, there is a paucity of studies to manage the condition. As threatened abortion remains one of the important pregnancy outcomes, it’s management requires more evidence-based research. This study compares oral dydrogesterone and oral micronized progesterone in threatened abortion, its efficacy and side effects.
|