| CTRI Number |
CTRI/2025/03/082243 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
16/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Randomized controlled Trial of PGE2 gel versus Transcervical Foley Catheter for Induction of Labor in Women with Previous Cesarean Section
|
|
Scientific Title of Study
|
A Randomized controlled Trial of PGE2 gel vs Transcervical Foleys Catheter for Induction of Labor in Women with Previous Cesarean Section
|
| 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 Priya |
| Designation |
Junior resident |
| Affiliation |
AIIMS JODHPUR |
| Address |
3rd floor , Medical college Department of Obstetrics & Gynaecology
AIIMS Jodhpur Ward no 17 old tehsil road , near water works , arya nagar , jhajjar , Haryana
Pincode - 124103 Jodhpur RAJASTHAN 342005 India |
| Phone |
8930902843 |
| Fax |
|
| Email |
priyagujjar11111@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Manu Goyal |
| Designation |
Additional Professor |
| Affiliation |
AIIMS JODHPUR |
| Address |
3rd floor Medical college , Department of Obstetrics & Gynaecology
AIIMS Jodhpur
Jodhpur RAJASTHAN 342005 India |
| Phone |
9971833603 |
| Fax |
|
| Email |
drmanu_8@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Priya |
| Designation |
Junior resident |
| Affiliation |
AIIMS JODHPUR |
| Address |
3rd floor Department of Obstetrics & gynaecology Medical college , AIIMS Jodhpur
Jodhpur RAJASTHAN 342005 India |
| Phone |
8930902843 |
| Fax |
|
| Email |
priyagujjar11111@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Jodhpur |
| Address |
Department of Obstetrics and Gynaecology , 3rd floor , medical college , AIIMS JODHPUR , Rajasththan
Pin code - 342005 |
| 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 PRIYA |
AIIMS JODHPUR |
DEPARTMENT OF OBSTETRICS & GYNAECOLOGY , 3RD FLOOR , MEDICAL COLLEGE , AIIMS JODHPUR Jodhpur RAJASTHAN |
8930902843
priyagujjar11111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS JODHPUR INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, (2) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Induction by PGE2 gel |
Induction of labor by Foleys catherter compared to Induction of labour by PGE 2 gel in Women with prevous 1 LSCS |
| Intervention |
Induction OF LABOUR by Foleys catheter |
Induction of labor by Foleys catherter compared to Induction of labour by PGE 2 gel in Women with prevous 1 LSCS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women with history of previous one Lower segment cesarean section with
Singleton pregnancy
Gestational age more than 34 weeks
Cephalic presentation
Bishop score of less than or equal to 6
Reactive Non stress test
Patients willing for Vaginal delivery after previous one LSCS
|
|
| ExclusionCriteria |
| Details |
Contraindication to use of prostaglandins like history of bronchial asthma
Previous uterine surgery other than Lower segment cesarean section
Placenta Previa
Active genital tract infection
Abnormal fetal heart rate pattern
Allergy to latex
Patient refusal for consent of induction or vaginal delivery
Any other contraindication for TOLAC
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the change in Bishop score after 12 hours of induction with PGE 2 gel and transcervical Foley catheter in women with previous one LSCS.
|
2 years
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare mode of delivery between PGE2 gel versus Foleys catheter used for induction of labor
|
2 years |
| To compare the rate of fetal distress between PGE2 gel versus transcervical Foley catheter for induction of labor in women with previous one LSCS |
2 years |
| To compare induction to delivery interval between PGE 2 gel versus transcervical Foley catheter |
2 years |
| To compare maternal complications like uterine tachysystole uterine rupture between PGE2 gel & Foley catheter useof labor in used for induction of labor in women with previous 1 LSCS |
2 years |
| To compare APGAR score between PGE2 & Foley catheter used for induction of labor in women with previous 1 LSCS |
2 years |
|
|
Target Sample Size
|
Total Sample Size="62" Sample Size from India="62"
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)
|
20/03/2025 |
| 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="2" Months="0" 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
|
Repeat cesarean section
exposes women to multiple risks like blood loss, injury to the urinary tract,
infections, adherent placenta, and cesarean hysterectomy. Vaginal birth after
cesarean section is a procedure that can be offered to women who have had a
prior cesarean section.
Induction of labor is
often taken up in the interest of the mother and the fetus. Labor induction in
the presence of an unfavorable cervix is associated with labor dystocia and a
higher incidence of repeat cesarean section. Hence, the use of cervical ripening
agents is beneficial. Induction with Foley catheter is a safe, inexpensive, and
reliable method of cervical ripening, with a low risk of uterine tachysystole
and fetal distress but poses a potential danger of accidental rupture of
membranes, cord prolapse, chorioamnionitis, and pyrexia because of infection.5 While PGE 2 gel has also been proven to be effective for
cervical ripening agents with a gradual onset of labor with the advantage of
single application. Many studies that have evaluated cervical ripening with
prostaglandin E2 (PGE2) insert have shown conflicting
results and in the absence of conclusive studies, many countries continue to
use PGE2 for induction of labor.
Intracervical Foley
catheter has been proven efficient in achieving cervical ripening and
successful labor with reduction in latent phase of labor and total delivery
time without increasing the rate of cesarean section, uterine tachysystole, and
uterine rupture. Considering the good performance of maternal and neonatal
outcomes, the intracervical Foley catheter has been suggested as a better choice for preinduction cervical
ripening and induction of labor in women with previous cesarean sections in
resource-limited settings.
Therefore, we decided to conduct a Randomized controlled trial at the
setting of AIIMS Jodhpur to compare the effectiveness and safety profile of PGE2
gel with intracervical Foley’s catheter
for ripening of cervix and induction of labor in women with previous 1 lower
segment cesarean section
Sample size has been calculated to be62
patients (with31 patients in each group) considering alpha of 0.05 ,90% power
and 20% attrition rate. Patients will be selected as per inclusion and
exclusion criteria and preinduction workup will done followed by enrollment and
consent . Group 1 and Group 2 will
continue to be compared even after achieving
of primary objective of study (difference in change of Bishop score
between PGE2 gel and Foleys catheter ).
Various parameters like Bishop score , presence of fetal distress ,
induction to delivery interval , mode of delivery , Apgar score will be noted
and compared between the two methods of induction of labor . All
the results will be evaluated statistically and whether any significant
difference present or not will be noted. The entire study will be
performed as per the ethical guidelines and monitoring and
treatment will be done as per standard
hospital policy .
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