| CTRI Number |
CTRI/2024/02/063299 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
23/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare outcomes of spontaneous and induced labour after expected date of delivery. |
|
Scientific Title of Study
|
To compare maternal and fetal outcome in spontaneous labor and induced labor beyond 40 weeks of gestation. |
| 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 Meenakshi Thakur |
| Designation |
Junior Resident |
| Affiliation |
Dr Rajendra Prasad Government College Tanda At Kangra |
| Address |
Dr Rajendra Prasad Government College Tanda At Kangra
OBG Department
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9459719001 |
| Fax |
|
| Email |
meenakshithakur9613@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Gupta |
| Designation |
Professor |
| Affiliation |
Dr Rajendra Prasad Government College Tanda At Kangra |
| Address |
Department of obstetrics and gynaecology
Dr Rajendra Prasad Government College Tanda At Kangra
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
|
| Fax |
|
| Email |
dramit203@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meenakshi Thakur |
| Designation |
Junior Resident |
| Affiliation |
Dr Rajendra Prasad Government College Tanda At Kangra |
| Address |
Dr Rajendra Prasad Government College Tanda At Kangra
OBG Department
HIMACHAL PRADESH
176001
India |
| Phone |
9459719001 |
| Fax |
|
| Email |
meenakshithakur9613@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of obstetrics and gynaecology
Dr Rajendra Prasad Government Medical College Tanda at Kangra
176001
Himachal Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr Meenakshi Thakur |
| Address |
Dr RPGMC Tanda Kangra |
| 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 Meenakshi thakur |
Dr Rajendra Prasad Government College Tanda At Kangra |
Department of obstetrics and gynaecology
Kangra
HIMACHAL PRADESH |
9459719001
meenakshithakur9613@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr RPGMC kangra at tanda IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
pregnant females |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
induction of labor done at term |
Tab msoprostol 25mcg given sublingually 4 hourly 4 doses to patients at full term |
| Comparator Agent |
spontaneous labor |
patients with spontaneous onset of labor are augmented |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Pregnancy beyond 40 weeks of gestational age up to
42 weeks with regular menstrual cycles, with sure
LMP and first trimester scan if available
2.Singleton pregnancy.
3.Cephalic presentation.
|
|
| ExclusionCriteria |
| Details |
1.Premature rupture of membranes
2.Associated medical problems like diabetes mellitus, cardiac diseases, renal diseases, pre-eclampsia.
3.Contraindication to induction of labor such as intrauterine growth restriction, fetal distress (non-reactive CTG), cephalopelvic disproportion, placenta previa, chronic placental insufficiency, abnormal fetal presentations (transverse lie or breech),cord presentation.
4.Previous cesarean section
5.Mode of induction other than misoprostol 25 mcg sublingually
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare maternal and fetal outcome in spontaneous labor and induced labor (with misoprostol 25 mcg 4 doses 4 hour apart) beyond 40 weeks of gestation. |
To compare maternal and fetal outcome in spontaneous labor and induced labor (with misoprostol 25 mcg 4 doses 4 hour apart) beyond 40 weeks of gestation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comfort of patient in labour |
1 year |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
11/03/2024 |
| 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 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
|
It will be a hospital based prospective
comparative study conducted in the Department of Obstetrics and Gynecology at
Dr RPGMC Tanda at Kangra which will include all the pregnant women who have
crossed their expected date of delivery meeting the inclusion and exclusion
criteria admitted to labor/obstetrics ward for delivery over a period of 1
year. The obstetric outcomes of induced and spontaneous groups beyond term shall be analysed to finalise a rationale whether induction of labor should be done at period of gestation beyond expected date of delivery or patient should be allowed to go into spontaneous labor after expected date of delivery. |