| CTRI Number |
CTRI/2024/05/067880 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
19/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study of efficacy of Prostaglandin F2A gel alone and mifepristone with ProstaglandinF2A gel as cervical ripening agent |
|
Scientific Title of Study
|
Comparative study of efficacy of dinoprostone gel alone and mifepristone with dinoprostone gel as cervical ripening agent |
| 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 Charu Jain |
| Designation |
Assistant Professor |
| Affiliation |
Command Hospital Air Force, Bengalore |
| Address |
Division -01, Room No -6
Department of Obstetrics and Gynecology
Command Hospital Airforce
Bengaluru
Bangalore
KARNATAKA
560007
India |
| Phone |
9571330102 |
| Fax |
|
| Email |
amitcharu0412@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charu Jain |
| Designation |
Assistant Professor |
| Affiliation |
Command Hospital Air Force, Bengalore |
| Address |
Division -01, Room No -6
Department of Obstetrics and Gynecology
Command Hospital Airforce
Bengaluru
Bangalore
KARNATAKA
560007
India |
| Phone |
9571330102 |
| Fax |
|
| Email |
amitcharu0412@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Charu Jain |
| Designation |
Assistant Professor |
| Affiliation |
Command Hospital Air Force, Bengalore |
| Address |
Division -01, Room No -6
Department of Obstetrics and Gynecology
Command Hospital Airforce
Bengaluru
Bangalore
KARNATAKA
560007
India |
| Phone |
9571330102 |
| Fax |
|
| Email |
amitcharu0412@gmail.com |
|
|
Source of Monetary or Material Support
|
| Command Hospital Airforce Bangalore |
|
|
Primary Sponsor
|
| Name |
DR M Rasheed |
| Address |
Command Hospital Airforce Bangalore
Cambridge Layout
Bangalore, Karnataka
Pin-560007 |
| 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 Charu Jain |
Command Hospital Air Force, Bangalore |
Room No-06, Division-01
Department of Obstetrics and Gynecology
Command Hospital Air Force, Bangalore
Cambridge Layout, Bangalore, Karnataka
PIN.560007
Bangalore
KARNATAKA |
9571330102
amitcharu0412@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Command Hospital Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dinoprostone gel(PGF2A) |
Dose-0.5mg
Route of administration- Per Vaginal
Frequency-6 hrs interval
Duration of therapy-total 3 doses
Local application of prostaglandin E2 – dinoprostone – is commonly used for cervical ripening |
| Comparator Agent |
Tab Mifepristone 200 mg With Dinoprostone gel(PGF2A) |
Mifepristone 200 mg orally single dose.
Dinoprostone gel
Dose-0.5mg Route of administration- Per Vaginal Frequency-6 hrs interval Duration of therapy-total 3 doses
Mifepristone/RU-486, a new class of pharmacological agent (antiprogesterone), has been developed to antagonize the action of progesterone. It is the 19 nor-steroid, which has greater affinity for progesterone receptor than does progesterone itself. It blocks the action of progesterone at the cellular level.Mifepristone also is a steroidal compound that has antiglucocorticoid and antiprogesterone properties. Progesterone stops uterine contractions, so mifepristone is used to stop the action of this hormone; thus, it induces labor or allows the pregnancy to be terminated. Mifepristone is a potential method of inducing labor in late pregnancy through its action in antagonizing progesterone, thus increasing uterine contractility and increasing the sensitivity of uterus to the action of prostaglandins. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Term singleton pregnancy in Cephalic Presentation with intact membrane with Bishop score less than 5 |
|
| ExclusionCriteria |
| Details |
Any presentation other than cephalic, pregnancy with asthma, any contraindication to prostaglandins, previous uterine scars, multiple pregnancy |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Bishop score after 6 hrs of 1st dose of diniprostone gel
2.Induction to delivery time
3.mode of delivery
|
12 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. APGAR score of neonate at birth & after 5min
2.PPH
3.hospital stay. |
12 months |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
25/06/2024 |
| 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 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
|
- The process by which the cervix becomes soft, compliant and partially dilated is termed “cervical ripening.†Cervical ripening is thought to be due to combination of biochemical, endocrinal , mechanical, and possibly inflammatory events. Cervical ripening allows the uterine contractions to effectively dilate the cervix.The goal of cervical ripening is to facilitate the process of cervical softening, effacement and dilatation, thus reducing the induction-to-delivery time. When there is an indication for induction and the cervix is unfavorable, agents for cervical ripening may be used.The two major techniques for iatrogenic cervical ripening are.Mechanical interventions, such as insertion of catheters or cervical dilators and Pharmacological such as application of cervical ripening agents (prostaglandins).Successful labour induction is related to state of the cervix. Pregnant lady with unfavorable cervix, who have not experienced cervical ripening phase prior to labour, present a great challenge with regard to induction of labour. So, Bishop’s scoring is done to see whether the cervix is favorable or not. If induction is done in an unfavorable cervix, chances of prolonged labour and chances of having cesarean section will be increased. To reduce cesarean section rate cervical ripening is done prior to induction. Local application of prostaglandin E2 – dinoprostone – is commonly used for cervical ripening.Mechanical interventions, such as insertion of catheters or cervical dilators and Pharmacological such as application of cervical ripening agents (prostaglandins).Successful labour induction is related to state of the cervix. Pregnant lady with unfavorable cervix, who have not experienced cervical ripening phase prior to labour, present a great challenge with regard to induction of labour. So, Bishop’s scoring is done to see whether the cervix is favorable or not. If induction is done in an unfavorable cervix, chances of prolonged labour and chances of having cesarean section will be increased. To reduce cesarean section rate cervical ripening is done prior to induction. Local application of prostaglandin E2 – dinoprostone – is commonly used for cervical ripening.Mifepristone/RU-486, a new class of pharmacological agent (antiprogesterone), has been developed to antagonize the action of progesterone. It is the 19 nor-steroid, which has greater affinity for progesterone receptor than does progesterone itself. It blocks the action of progesterone at the cellular level.Mifepristone also is a steroidal compound that has antiglucocorticoid and antiprogesterone properties. Progesterone stops uterine contractions, so mifepristone is used to stop the action of this hormone; thus, it induces labor or allows the pregnancy to be terminated. Mifepristone is a potential method of inducing labor in late pregnancy through its action in antagonizing progesterone, thus increasing uterine contractility and increasing the sensitivity of uterus to the action of prostaglandins.After meeting the eligibility criteria, all patients will be randomly allocated to two groups after written & informed consent.Group A (n=100) cervical ripening with dinoprostone gel.Group B ( n= 100) with mifepristone 200 mg followed 48 hrs by dinoprostone gel.Maximum of 3 doses of 0.5mg dinoprostone gel with an interval of 6 hrs.
- Primary outcome : Bishop score after 6 hrs of 1st dose of diniprostone gel , Induction to delivery time, mode of delivery.
- Secondary outcome : APGAR score of neonate at birth & after 5min, PPH, hospital stay.
|