| CTRI Number |
CTRI/2023/06/054373 [Registered on: 23/06/2023] Trial Registered Prospectively |
| Last Modified On: |
22/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Induction of labor] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of Foleys catheter with PGE2 and foleys catheter with misoprostol as a induction method for preterm fetuses |
|
Scientific Title of Study
|
Comparison of intracervical foleys catheter with extra amniotic saline infusion versus intracervical foleys catheter with misoprostol for cervical ripening in extremely, moderate and very preterm fetuses: A randomized 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 |
Amitha Kamat |
| Designation |
Associate Professor |
| Affiliation |
Karnataka Institute Of Medical Sciences and Research Hospital, Hubli |
| Address |
Room no. 50, MCH Building, Department of Obstetrics and Gynecology,Karnataka Institute of Medical Sciences and Research Hospital, Vidyanagar, Hubli
No.12,2nd cross,opposite to KIMS, Vidyanagar, Hubli, Karnataka , India
Dharwad
KARNATAKA
580029
India |
| Phone |
9243283403 |
| Fax |
|
| Email |
amithakamat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Annie Jesline Dmello |
| Designation |
Postgraduate |
| Affiliation |
Karnataka Institute of Medical Sciences and Research Hospital, Hubli |
| Address |
Room no.50, MCH Building, Department of Obstetrics and Gynecology, Karnataka Institute of Medical Sciences and Research Hospital, Vidyanagar, Hubli, Dharwad
no. 11, 3rd cross, Mayura Estate, near Medplus store, Vijayanagar, Hubli, Dharwad
Dharwad
KARNATAKA
580029
India |
| Phone |
8310508268 |
| Fax |
|
| Email |
a96jesline@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Annie Jesline Dmello |
| Designation |
Postgraduate |
| Affiliation |
Karnataka Institute of Medical Sciences and Research Hospital, Hubli |
| Address |
Room no.50, MCH Building, Department of Obstetrics and Gynecology, Karnataka Institute of Medical Sciences and Research Hospital, Vidyanagar, Hubli
no. 11, 3rd cross, Mayura Estate, near Medplus store, Vijayanagar, Hubli, Dharwad
Dharwad
KARNATAKA
580029
India |
| Phone |
8310508268 |
| Fax |
|
| Email |
a96jesline@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karnataka Institute Of Medical Sciences and Research Hospital, Hubli, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Annie Jesline Dmello |
| Address |
Karnataka Institute of Medical Sciences and Research Hospital, Vidyanagar, Hubli |
| 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 |
| Annie Jesline Dmello |
Karnataka Institute Of Medical Sciences and Research Hospital |
Room no. 50, MCH building, Department of Obstetrics and Gynecology, Karnataka Institute Of Medical Sciences and Research Hospital, Hubli
Dharwad
KARNATAKA |
8310508268
a96jesline@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Karnataka Institute of Medical Sciences, Hubli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Labor induction with foleys catheter and misoprostol versus induction with foleys catheter and extra-amniotic saline infusion |
patients in need of induction of labor due to the below mentioned reasons will be randomly allocated to the 2 groups foleys with misoprostol and foleys with EASI |
| Intervention |
Labor induction with foleys catheter and misoprostol versus induction with foleys catheter and extra-amniotic saline infusion |
patients in need of induction of labor due to the below mentioned reasons will be randomly allocated to the 2 groups foleys with misoprostol and foleys with EASI |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
All pregnant females between gestational age of 26 weeks to 34 weeks requiring termination of pregnancy due to Intra uterine fetal demise, severe oligohydramnios, lethal congenital abnormality |
|
| ExclusionCriteria |
| Details |
presence of cervicovaginal infection, multiple pregnancy, antepartum hemorrhage, placenta previa |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
change/ improvement in bishops score
|
8th hourly reassessment
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
mode of delivery
postpartum sepsis rate |
induction to delivery interval |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
05/07/2023 |
| 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="6"
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
|
This study aims to determine the effectiveness of intracervical foleys catheter with extra amniotic saline infusion (EASI) versus intracervical foleys with misoprostol for cervical ripening in extremely, moderate and very preterm fetuses. |