| CTRI Number |
CTRI/2024/02/062661 [Registered on: 15/02/2024] Trial Registered Prospectively |
| Last Modified On: |
11/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
Dinoprostone vaginal insert vs Oral misoprostol in induction of labour |
|
Scientific Title of Study
|
Comparative study of Dinoprostone vaginal insert and oral misoprostol for Induction of 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 |
Naga Manikya Veena G |
| Designation |
Junior resident |
| Affiliation |
Kasturba Medical college,Manipal |
| Address |
Kasturba Hospital,Department of obstetrics and Gynecology,Manipal,Karnataka
KARNATAKA
576104
India |
| Phone |
8008869136 |
| Fax |
|
| Email |
gannabathulaveena@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrJyothi Shetty |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College,Manipal |
| Address |
Kasturba Hospital,Department of Obstetrics and Gynecology,Madhav Nagar,Manipal,Udupi district
Udupi
KARNATAKA
576104
India |
| Phone |
9845973697 |
| Fax |
|
| Email |
jthshetty@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrJyothi Shetty |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College,Manipal |
| Address |
Kasturba Hospital,Department of Obstetrics and Gynecology,Madhav Nagar,Manipal,Udupi district
Udupi
KARNATAKA
576104
India |
| Phone |
9845973697 |
| Fax |
|
| Email |
jthshetty@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College,Madhav Nagar,Manipal,Udupi district,Karnataka |
|
|
Primary Sponsor
|
| Name |
Naga Manikya Veena |
| Address |
Kasturba Hospital,Department of obstetrics and Gynecology,Madhav Nagar,Manipal |
| 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 |
| DrJyothi Shetty |
Kasturba Hospital |
Department of Obstetrics and Gynecology,Manipal,Udupi district
Udupi
KARNATAKA |
9845973697
gannabathulaveena@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 |
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 |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Cephalic presentation normal fetal heart rate bishop score less than 4 Singleton pregnancy gestational age greater than 37weeks |
|
| ExclusionCriteria |
| Details |
Previous Caesarean section previous uterine surgery Abnormal presentations estimated fetal weight greater than 4000grams Hypersensitivity to dinoprostone |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Obstetrical outcome:
mode of delivery,induction to delivery time interval,Caesarean section rate
|
During the time of delivery.At term i.e greater than 37weeks of period of gestation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| APGAR score, NICU stays and other neonatal complications |
At time of delivery |
|
|
Target Sample Size
|
Total Sample Size="158"
Sample Size from India="158"
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)
|
21/02/2024 |
| 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="6"
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
|
Eligible pregnant women >37weeks are recruited in the study. Dinoprostone vaginal insert and Oral Misoprostol both are used as a standard of care and are used routinely for induction of labour in labour ward. Choice of drug for Induction of labour is provided to the patient. Patient will decide the method of induction.If patient is unable to decide,unit consultant will decide the method of induction. Participitants are recruited to the study based on inclusion criteria. All eligible women who are planned for Induction of labour with either of the drug can be recruited into the study. Women are advised in-patient admission prior to induction. Informed consent will be taken before induction.Pre-induction Cardiotocography will be done. In case of, Dinoprostone vaginal insert, it is kept in posterior fornix of cervix and patient is asked to lie down for 2 hours. Dinoprostone vaginal insert can be left for 24 hours and watched for progress .In Women receiving oral misoprostol , a dose of 25mcg will be given ,which will be repeated to a maximum of six doses if required. Misoprostol 25 μg tablets will be mixed in 25 mL of water and given orally every 2 hours .Per-vaginal examination to assess Bishop’s score will be done. Misoprostol will be administered until cervical dilatation of > 3cm or adequate uterine contractions ( 3 to 4 contractions lasting for 45 seconds in a period of 10 minutes).Strict feto-maternal surveillance done with Cardiotocography at regular intervals.In either of the methods of induction,Artificial rupture of membranes will be done if cervical dilatation >4cm . Intravenous oxytocin infusion augmentation will be commenced in cases with infrequent uterine contractions. Oxytocin infusion will be started at least 4 hours after misoprostol and was given for a maximum of 8 h. In women those, who did not progress with oral misoprostol ,option for re-induction with Dinoprostone intracervical gel 0.5mg is provided to the patient. Dinoprostone intracervical gel is used every 6th hourly the next day following oral Misoprostol. Dinoprostone gel is kept 80% intracervically and 20% in posterior fornix and watched for progress. The main outcome measure is the induction to delivery interval in those delivering vaginally. Secondary outcome measures included the number of doses of misoprostol, operative delivery rates, incidence of side effects and neonatal outcome |