| CTRI Number |
CTRI/2024/10/075800 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
21/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia
Diagnostic
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of effectiveness of early versus expectant artificial rupture of membranes in reducing induction delivery interval following cervical ripening by combined misoprostol and mechanical method |
|
Scientific Title of Study
|
Efficacy of early versus expectant artificial rupture of membranes in reducing induction delivery interval following cervical ripening by combined misoprostol and mechanical method : a randomized controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NONE |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arti Verma |
| Designation |
Junior Resident |
| Affiliation |
King Georges Medical University Lucknow |
| Address |
Department of Obstetrics and Gynaecology
Queen Mary hospital
King George medical university
Shahmina Road
Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9690456432 |
| Fax |
|
| Email |
artiv800@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manju Lata Verma |
| Designation |
Additional Professor |
| Affiliation |
King Georges Medical University Lucknow |
| Address |
Additional Professor
Department of Obstetrics and Gynaecology
Queen Mary hospital
King George medical university
Shahmina Road
Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9721250092 |
| Fax |
|
| Email |
gaganmlv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manju Lata Verma |
| Designation |
Additional Professor |
| Affiliation |
King Georges Medical University Lucknow |
| Address |
Additional Professor
Department of Obstetrics and Gynaecology
Queen Mary hospital
King George medical university
Shahmina Road
Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9721250092 |
| Fax |
|
| Email |
gaganmlv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Obstetrics and gynaecology King Georges Medical University Lucknow |
|
|
Primary Sponsor
|
| Name |
Dr Arti Verma |
| Address |
Junior Resident,Department of Obstetrics and Gynaecology
Queen Mary hospital
King George medical university
Shahmina Road
Lucknow
Uttar Pradesh |
| 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 Arti Verma |
Queen Mary Hospital King Georges Medical University |
Room No 1,Labour room complex
Department of Obstetrics and Gynaecology
Queen Mary Hospital
King Georges Medical university
Shahmina Road
Lucknow
Uttar pradesh
Lucknow
UTTAR PRADESH |
9690456432
artiv800@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King Georges Medical University U.P.,Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O239||Unspecified genitourinary tract infection in pregnancy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A [EARLY ARTIFICIAL RUPTURE OF MEMBRANES] |
Patient giving informed written consent with singleton pregnancy with cephalic presentation needing induction of labour at or after 37 weeks of gestation will be randomized into 2 groups viz. Group A and Group B .All patients in this trial will undergo combination of foley catheter insertion and misoprostol for induction of labor.
In Group A(Early Artificial Rupture of Membranes) , artificial rupture of membranes will be done immediately after intracervical foley catheter expulsion |
| Comparator Agent |
Group B [Expectant Artificial Rupture Of Membranes] |
In Group B(Expectant Artificial Rupture of Membranes) , artificial rupture of membranes will be done after 4 hours of intracervical foley catheter expulsion |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Individuals aged 18 or above
Patients who need induction of laborAt or37 0 7 weeks of gestation
Singleton pregnancy
Cephalic presentation
Women giving written informed consent will be taken
|
|
| ExclusionCriteria |
| Details |
Known Previous uterine scar
fetal demise
known major fetal congenital anomaly
HIV infection, or hepatitis C before the start of labor induction
Premature rupture of membranes, preterm premature rupture of membranes
patient not giving consent
Category 3 fetal heart rate tracing,hemolysis, elevated liver enzymes, and low platelets syndrome or eclampsia; growth restriction 10th percentile (based on Hadlock growth curves) with reversal of flow in umbilical artery Doppler; or growth restriction
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| time to delivery (hours) |
time from start of induction to
delivery, |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
time to active labor
Cesarean delivery rate
Number of neonates requiring NNU/NICU admission |
time to active labor
[ time taken from starting of cervical dilatation till dilatation reach upto 6 cm]
Number of neonates requiring NNU/NICU admission
[time frame immediately post deivery] |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/11/2024 |
| 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="1"
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
|
Patients will be enrolled in the study according to inclusion and exclusion criteria.Patients with singleton pregnancy, cephalic presentation with informed written consent, needing induction of labour at or after 37 weeks of gestation will be included.Patient with known previous scar,fetal demise ,fetal congenital anomaly ,with HIV or Hepatitis infection or category 3 fetal heart tracing or not giving consent will be excluded. Eligible patients [n=66] will be randomized into 2 groups , Group A (Early artificial rupture of membranes) and Group B (Expectant artificial rupture of membranes).Randomization will be done by sequentially numbered opaque sealed envelope technique.All patients in this trial will undergo combination of intracervical foley catheter insertion and misoprostol for induction of labour.Foley catheter will be placed above the level of internal is and inflated with 40 cc sterile water.In addition,1 misoprostol tab 25 microgram will be placed high into posterior vaginal fornix at the time of foley catheter insertion.Subsequent doses will be repeated every 4 hours upto 5 additional doses or a maximum of 24 hours. In group A (Early artificial rupture of membranes),[n=33], artificial rupture of membranes will be done immediately after intracervical foley catheter expulsion In group B (Expectant artificial rupture of membranes) ,[n=33],artificial rupture of membranes will be done after 4 hours of intracervical foley catheter expulsion . Post foley catheter expulsion,if the bishop score is poor(8) then we will continue further induction with oxytocin .Fetomaternal surveillance will be done throughout induction,labor and delivery. Time to delivery (hours) [defined as the time from start of induction to delivery] will be assessed as primary outcome. Secondary outcome measures will include time to active labor (defined as Cervical dilatation as 6 cm), cesarean delivery rate, number of neonates requiring NNU/NICU admission |