| CTRI Number |
CTRI/2024/09/073383 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Intracervical Foleys catheter Buccal misoprostol and their combination for induction of labor |
|
Scientific Title of Study
|
Comparison of Intracervical Foleys catheter, buccal misoprostol and their combination for induction of labor |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arshed Ali |
| Designation |
Junior Resident |
| Affiliation |
Government medical college and hospital, Chandigarh |
| Address |
Department of Obstetrics and Gynaecology, Level4 D Block
Government Medical college and hospital, Chandigarh
160030
India
Chandigarh
CHANDIGARH
160030
India |
| Phone |
7006604669 |
| Fax |
|
| Email |
Aarshed471@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunita Dubey |
| Designation |
Professor |
| Affiliation |
Government Medical college and hospital, Chandigarh |
| Address |
Department of Obstetrics and Gynaecology, Level4 D Block
Government Medical college and hospital, Chandigarh
160030
India
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646323268 |
| Fax |
|
| Email |
sunitas504@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunita Dubey |
| Designation |
Professor |
| Affiliation |
Government Medical college and hospital, Chandigarh |
| Address |
Department of Obstetrics and Gynaecology, Level4 D Block
Government Medical college and hospital, Chandigarh
160030
India
CHANDIGARH
160030
India |
| Phone |
9646323268 |
| Fax |
|
| Email |
sunitas504@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical College hospital, Chandigarh
Sector 32 Chandigarh
pincode 160030
160030
INDIA |
|
|
Primary Sponsor
|
| Name |
Director Principal, Government Medical College and Hospital, Sector-32, Chandigarh |
| Address |
Government Medical College and Hospital,
Sector-32, Chandigarh
160030
India |
| 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 |
| Dr Arshed Ali |
Government Medical college and hospital, Chandigarh |
Department of obstetrics and gynaecology, Level 4 D block
Government Medical college and hospital, Chandigarh
160030
India
Chandigarh
CHANDIGARH |
7006604669
Aarshed471@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 |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
buccal misoprostol |
Patients falling in this group will receive 25mcg misoprostol bucally. the drug will be repeated at 4 hourly intervelupto a maximum of 6 doses or till the bishop score of 6 or active labor begins |
| Comparator Agent |
buccal misoprostol and Intracervical Foleys |
This group of patients will receive both buccal misoprostol and intracervical Foleys catheter. Foleys will be removed after 8 hours if not expelled spontaneously. Misoprostol will be repeated 4 hourly , upto a maximum 6 doses or till bishops 6 or till active labor begins |
| Intervention |
Intracervical Foleys catheter for Induction of labor |
Intracervical Foleys will be inflated with 30cc volume under all aseptic precautions and the catheter will be taped to the inner thigh to maintain traction. Foleys catheter will be removed after 8 hours of insertion if not expelled spontaneously |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Women with Cephalic singleton pregnancy from 34 to 41 weeks with a specific indication for induction of labor such as
Abruptio placenta , chorioamnionitis, gestational hypertension, preeclampsia, eclampsia, Prelabor rupture of membrane, postterm pregnancy, Diabetes mellitus, chronic hypertension, Fetal growth restriction, Oligohydraminos |
|
| ExclusionCriteria |
| Details |
Estimated fetal weight ≤1.500 kg to ≥3.5 kg.
• Multifetal gestation
• Non-reassuring fetal heart rate tracing
• Poor biophysical profile
• Congenital anomalies of the fetus
• Intrauterine death of the fetus
• Previous caesarean delivery or other uterine surgery (myomectomy, hysterotomy)
• History of ante partum hemorrhage including placenta previa, vasa previa
• Cephalopelvic disproportion
• Any contraindication of vaginal delivery
• Cervical cancer
• History of cervical tear or any surgery
• Contraindications & hypersensitivity to prostaglandins
• Parity≥5 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The induction to active phase interval, induction-to-delivery interval.
• Rate of successful vaginal birth within 24 hours.
• Rate of caesarean section and operative vaginal deliveries. |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Maternal outcome:
• Uterine hyperstimulation (defined as either tachysystole or hypertonus with a nonreassuring fetal heart-rate pattern on cardiotocography).
• Maternal infection (defined as a temperature ≥ 38°C at any time during labour or delivery,
wound infection either episiotomy or cesarean scar site, endometritis.
• Primary Postpartum hemorrhage
• Uterine rupture.
Fetal outcome:
• Still birth, Meconium aspiration syndrome & APGAR score.
• Need of Neonatal intensive care (NICU).
|
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
30/09/2024 |
| 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="0"
Months="6"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 is aimed to compare the effectiveness of buccal misoprostol, Intracervical Foleys catheter and the combination of both for induction of labor A total of 132 of antenatal patients will be recruited by computerized generated randomization , each will be induced with one of the above method of induction of labor after taking proper consent. Each group will be compared for induction to delivery intervel, rate of vaginal and cesarean deliveries |