| CTRI Number |
CTRI/2024/09/073480 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
04/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of misoprostol tablet given by sublingual and vaginal route in full term pregnant patients. |
|
Scientific Title of Study
|
Efficacy of sublingual vs vaginal misoprostol tablet for induction of labour in term antenatal women : 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 |
Deepakshi Gupta |
| Designation |
Junior Resident |
| Affiliation |
nkpsims, nagpur |
| Address |
Labour room, Department of Obstetrics and Gynaecology, Lata Mangeshkar Hospital, Hingna , Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
09021189372 |
| Fax |
|
| Email |
deepakshigupta993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Varsha Kose |
| Designation |
Professor |
| Affiliation |
Lata Mangeshkar Hospital, Hingna, Nagpur |
| Address |
Labour room, Department of Obstetrics and Gynaecology, Lata Mangeshkar Hospital, Hingna, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
8087079132 |
| Fax |
|
| Email |
auttarwars@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepakshi Gupta |
| Designation |
Postgraduate student |
| Affiliation |
Lata Mangeshkar Hospital, Hingna, Nagpur |
| Address |
Labour room, Department of Obstetrics and Gynaecology, Lata Mangeshkar Hospital, Hingna, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
09021189372 |
| Fax |
|
| Email |
deepakshigupta993@gmail.com |
|
|
Source of Monetary or Material Support
|
| Labour room, Lata Mangeshkar Hospital, Hingna, Nagpur - 440019, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Deepakshi Gupta |
| Address |
Labour room, Department of Obstetrics and Gynaecology, Lata Mangeshkar Hospital, Hingna , Nagpur - 440019, Maharashtra, India |
| 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 Deepakshi Gupta |
Lata Mangeshkar Hospital |
Labour room, Department of Obstetrics and Gynaecology, Lata Mangeshkar Hospital, Hingna, Nagpur
Nagpur
MAHARASHTRA |
9021189372
deepakshigupta993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ehical Committee Report |
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 |
| Comparator Agent |
Misoprostol tablet for induction of labour |
Intravaginally 25mcg misoprostol tablet will be given to 50 randomly selected term antenatal patients for induction of labour. Patient to be re-assessed every four hours and if required misoprostol tablet to be repeated to a maximum of six doses only. |
| Intervention |
Misoprostol tablet for induction of labour |
Sublingually 25mcg misoprostol tablet will be given to 50 randomly selected term antenatal patients for induction of labour. Patient to be re-assessed every four hours and if required misoprostol tablet to be repeated to a maximum of six doses only. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Singleton full term pregnancy with vertex presentation.
Gravida 1 to 4 with clinically adequate pelvis
Bishop score <6
|
|
| ExclusionCriteria |
| Details |
Eclampsia
Uncontrolled diabetes mellitus
Women with previous cesarean section
Hypersensitivity to misoprostol |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of sublingual misoprostol tablet vs vaginal misoprostol tablet for induction of labour
In terms of :
Induction delivery interval
Mode of delivery
|
Improvement in Bishops score would be assessed every 4 hours. Maximum of 6 doses would be given.
Further dosing would be stopped if patients Bishops score becomes more than 6. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the side effects of tablet misoprostol in sublingual vs vaginal route |
Side effects like nausea, vomiting, diarrhea , uterine tachysystole were identified. Every four hourly re-assessment is done to look for progress of labour. |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/09/2024 |
| 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="0"
Months="2"
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
|
Induction of labour is
the artificial initiation of labour before its spontaneous onset for the
purpose of delivery of the fetoplacental unit using mechanical or
pharmacological method. Induction of labour is indicated wherever there is risk
to mother, foetus or both if pregnancy is further continued. The success of
labour induction depends on cervical status (Bishop’s score) at the time of
induction. Various
studies have used various doses of tablet misoprostol ranging from 25mcg to 100
mcg and they used different doses for both oral and vaginal route. This study
will be done to compare the efficacy of sublingual vs vaginal tablet
misoprostol for induction of labour in term antenatal women.
|