| CTRI Number |
CTRI/2020/08/027093 [Registered on: 11/08/2020] Trial Registered Prospectively |
| Last Modified On: |
31/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of safety and efficacy of chemical method vs mechanical method in inducing labour pains in a term pregnant mother |
|
Scientific Title of Study
|
Comparative study of safety and efficacy of intracervical Foley catheter balloon versus prostaglandin E2 gel for induction of labour in unfavourable cervix |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjani Devi S |
| Designation |
Post graduate in department of Obstetrics and Gynaecology |
| Affiliation |
The Tamilnadu Dr. MGR medical university |
| Address |
Department of obstetrics and Gynaecology,
Labour room complex,
2nd floor, new building,
ESIC medical college and PGIMSR
PG womens hostel,
Esi staff quarters,
Ashok pillar main road,kk Nagar.chennai-78
Chennai
TAMIL NADU
600078
India |
| Phone |
09840349617 |
| Fax |
|
| Email |
anjanisubramanian1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maya Menon |
| Designation |
Professor and HOD, department of Obstetrics and Gynaecology |
| Affiliation |
The Tamilnadu Dr. MGR medical university |
| Address |
Department of Obstetrics and Gynaecology,
2nd floor, new hospital building,
ESIC medical college and PGIMSR
Chennai
TAMIL NADU
600078
India |
| Phone |
9444477791 |
| Fax |
|
| Email |
mayasree@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anjani Devi S |
| Designation |
Post graduate in department of Obstetrics and Gynaecology |
| Affiliation |
The Tamilnadu Dr. MGR medical university |
| Address |
Department of Obstetrics and Gynaecology,
Labour room complex,
2nd floor, new building
ESIC medical college and PGIMSR
Chennai
TAMIL NADU
600078
India |
| Phone |
09840349617 |
| Fax |
|
| Email |
anjanisubramanian1@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Dean, Esic medical college and PGIMSR, kk Nagar, chennai-600078 |
|
|
Primary Sponsor
|
| Name |
Dr Maya menon |
| Address |
Department Of Obstetrics and Gynaecology, labour room complex, 2nd floor, new building,
Esic medical college and PGIMSR, kk Nagar, chennai |
| Type of Sponsor |
Government 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 |
| Anjani Devi S |
ESIC Medical college and PGIMSR |
Department of Obstetrics and Gynaecology, labour room complex, 2nd floor, new building, ESIC medical college and PGIMSR. Ashok pillar main road, kk Nagar, chennai-78
Chennai
TAMIL NADU |
09840349617
anjanisubramanian1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnant term mothers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cervical ripening for induction of labour in an unfavourable cervix |
Prostaglandin E2 gel
0.5mg in 3gm gel, applied intracervically
Applied 6th hourly
Upto a maximum of 3 doses |
| Intervention |
Cervical ripening for induction of labour in unfavourable cervix |
18FG Foleys catheter balloon applied intracervically.
Inflated with 30-50ml distilled water
Reassess for cervical changes after 12hrs
If required may use oxytocin augmentation/ cerviprime gel for further changes
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Primigravida, more than 37weeks gestation, singleton pregnancy, cephalic presentation, bishops score less than 5, intact membranes, reactive preinduction CTG |
|
| ExclusionCriteria |
| Details |
Multiple pregnancy, malpresentation, absent membranes, antepartum hemorrhage, previous uterine scar, active genital infections, major CPD, Medical conditions like heart disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post induction bishops score |
12 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean induction to delivery interval
Mode of delivery
Maternal and fetal outcome |
12 to 36hours |
|
|
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)
|
17/08/2020 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized double blind parallel group controlled trial comparing the efficacy and safety of intracervical Foley’s catheter balloon vs intracervical prostaglandin E2 gel in cervical ripening for induction of labour in term antenatal mother’s with unfavourable cervix conducted in 100 patients in Department of Obstetrics and Gynaecology , ESIC medical college and PGIMSR , kk Nagar , Chennai. The primary outcome measures are post induction changes in Bishop’s score. The secondary outcomes are mean induction to delivery interval, mode of delivery and maternal and feta outcomes. |