| CTRI Number |
CTRI/2024/07/070403 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
05/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
This is a study to compare the outcome of inducing labor
by using a tube inserted in cervix along with misoprostol medication either as oral solution or
as tablet kept under your tongue among women in their first pregnancy at term gestation requiring induction of labor |
|
Scientific Title of Study
|
Comparison of outcome of labor induction by combination of Foleys catheter with either titrated oral misoprostol solution or sublingual misoprostol among nulliparous women at term - A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lakshanya |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry |
| Address |
Department of Obstetrics and Gynecology,
Jawaharlal Institute of Postgraduate Medical Education and Research,
Dhanvantri Nagar,
Gorimedu,
Puducherry,
India
-
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9444415274 |
| Fax |
- |
| Email |
lakshanya123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Latha Chaturvedula |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry |
| Address |
Department of Obstetrics and Gynecology,
Jawaharlal Institute of Postgraduate Medical Education and Research,
Dhanvantri Nagar,
Gorimedu,
Puducherry,
India
-
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9486008274 |
| Fax |
- |
| Email |
jipoghod@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lakshanya |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry |
| Address |
Department of Obstetrics and Gynecology,
Jawaharlal Institute of Postgraduate Medical Education and Research,
Dhanvantri Nagar,
Gorimedu,
Puducherry,
India
-
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9444415274 |
| Fax |
- |
| Email |
lakshanya123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research,
Dhanvantri Nagar,
Gorimedu,
Puducherry,
India
Pincode- 605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research,
Dhanvantri Nagar,
Gorimedu,
Puducherry,
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 Lakshanya |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Labor Ward, Ground Floor, Women and Children’s Hospital, JIPMER, Dhanvantri Nagar, Gorimedu, Puducherry, India, Pincode- 605006
Pondicherry
PONDICHERRY |
9444415274
lakshanya123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry Institutional Ethics Committee- Interventional Studies CDSCO Reg. No. ECR/342/Inst/PY/2013/RR-19 |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral misoprostol solution |
22F Foley’s catheter will be introduced intracervically under aseptic precautions such that the bulb of the catheter lies over the internal os. The bulb will be then inflated with 60ml of distilled water. The patient will then be administered the additional induction agent as follows.
The first group will receive titrated oral misoprostol solution. The titrated oral misoprostol solution will be prepared by dissolving a 200mcg misoprostol tablet and a 25mcg misoprostol tablet in 225ml of drinking water, to make a solution with concentration of 1mcg/ml, which will be stored at room temperature for a maximum of 24 hours. The solution will be administered as follows:
Initial dose of 20mcg hourly for two doses; in the absence of adequate uterine contractions, the dose will be increased to 30 mcg hourly for three doses followed by 40 mcg for one dose, at an interval of 1.5 h, and 50 mcg for one dose.
If the first cycle of administration ended with no signs of regular uterine contraction, a second cycle will be started after an interval of 6 h. A maximum of 2 cycles will be given. Further doses will be stopped once the following are observed: regular uterine contractions of 3 in 10 mins lasting more than 40 seconds, fully effaced or dilation of the cervix more than or equal to 4.0 cm.
|
| Comparator Agent |
Sublingual misoprostol |
22F Foley’s catheter will be introduced intracervically under aseptic precautions such that the bulb of the catheter lies over the internal os. The bulb will be then inflated with 60ml of distilled water. The second group will be given sublingual misoprostol 25 mcg at intervals of 4 hours for a maximum of 6 doses. Further doses will be stopped once the following are observed: regular uterine contractions of 3 in 10 mins lasting more than 40 seconds, fully effaced or dilation of the cervix more than or equal to 4.0 cm. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1)Nulliparous women ≥ 18 years of age
2)Gestational age ≥ 37 weeks
3)Singleton pregnancy, vertex presentation
4)Bishop’s score less than or equal to 4
|
|
| ExclusionCriteria |
| Details |
1)Women with severe pre-eclampsia
2)Premature rupture of membranes
3)Previously scarred uterus (myomectomy/ septal resection)
4)Previous anaphylaxis to prostaglandins
5)Abnormal FHR changes
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of successful vaginal delivery |
72 hours after insertion of foleys catheter |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time from induction to delivery |
72 hours after insertion of foleys catheter |
| Maternal & fetal outcome |
72 hours after insertion of foleys catheter |
|
|
Target Sample Size
|
Total Sample Size="304"
Sample Size from India="304"
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)
|
25/07/2024 |
| 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="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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [lakshanya123@gmail.com].
- For how long will this data be available start date provided 15-07-2026 and end date provided 15-07-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is a randomised controlled trial to compare the outcome of induction of labor by intracervical Foley’s catheter with titrated oral misoprostol solution versus intracervical Foley’s catheter with sublingual misoprostol in nulliparous women at term. this study will be conducted for 18 months in a tertiary centre in South India. 152 women in one group will receive titrated misoprostol solution after insertion of intracervical Foley’s catheter, while 152 women in the other group will receive sublingual misoprostol after insertion of intracervical Foley’s catheter. The primary outcome is measured by the proportion of successful vaginal deliveries. the secondary outcomes observed will be the difference in the time from induction to delivery and incidence of any maternal or fetal adverse effects.
|