| CTRI Number |
CTRI/2025/02/081230 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
23/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [foleys with extra amniotic saline infusion/ foleys] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of two (foleys and foley with extra amniotic saline infusion) methods for induction of labour pains in pregnant women who are admitted for delivery |
|
Scientific Title of Study
|
Induction of labor in women with unfavorable cervix: A randomised controlled study to assess the effectiveness of intracervical foley’s catheter with extra amniotic saline infusion vs only foley’s catheter |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amrusha Mangavilli |
| Designation |
Post graduate resident |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Department of OBG
AIIMS Mangalagiri
Guntur-522503
Guntur ANDHRA PRADESH 522503 India |
| Phone |
9398872511 |
| Fax |
|
| Email |
mangavilliamrusha@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Vandana Kamatham |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Department of OBG
AIIMS Mangalagiri
Guntur-522503
Guntur ANDHRA PRADESH 522503 India |
| Phone |
9787424158 |
| Fax |
|
| Email |
dr.vandanakamatham@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Amrusha Mangavilli |
| Designation |
Post graduate resident |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Department of OBG
AIIMS Mangalagiri
Guntur-522503
ANDHRA PRADESH 522503 India |
| Phone |
9398872511 |
| Fax |
|
| Email |
mangavilliamrusha@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Amrusha Mangavilli |
| Address |
Department of OBG
AIIMS Mangalagiri |
| Type of Sponsor |
Other [CENTRAL GOVERNMENT INSTITUTE] |
|
|
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 |
| Amrusha Mangavilli |
AIIMS Mangalagiri |
Department of OBG
AIIMS Mangalagiri Guntur ANDHRA PRADESH |
9398872511
mangavilliamrusha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE 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 |
| Intervention |
extra amniotic saline infusion |
extra amniotic saline infusion will be given along with intracervical foleys catheter insertion in intervention group and foleys catheter alone in the control group |
| Comparator Agent |
foleys induction |
Under strict aseptic precautions 22F foleys catheter will be inserted into cervix under direct visualization by holding the tip of the catheter with an artery forceps , bulb of the foleys catheter will be inflated with 20cc normal saline and the catheter will be gently pulled back so as to assure the tip of the catheter is beyond internal os and bulb is exactly at the level of internal os.
Once the position of the catheter is confirmed the bulb will be further inflated with 40 cc of normal saline, a total of 60 cc of normal saline will be used for foley bulb inflation.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women planned for induction of labor
Singleton gestation
Intact membrane.
Cephalic presentation.
Unfavourable cervix |
|
| ExclusionCriteria |
| Details |
Women who are already in labour.
Previous c section
Previous history of any uterine surgeries (myomectomy, hysterotomy etc)
Non-reactive NST.
5. Low lying placenta / placenta previa/ vasa previa
Placental abruption.
Active genital herpes.
Malpresentation.
Contracted pelvis
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Post foley expulsion- improvement in bishops score
2. Requirement for further inducing agents post foley expulsion {misoprostol/pge2 gel/oxytocin}
3. Induction to entry into active phase of labor
4. Induction to delivery interval
|
BISHOP score more than 6 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Caesarean delivery rate
2. Incidence of chorioamnionitis
3. APGAR score at 1 & 5 mins
4. NICU admission rate
|
bishops score more than 6 |
|
|
Target Sample Size
|
Total Sample Size="96" Sample Size from India="96"
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)
|
06/03/2025 |
| 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 - 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
- Who will be able to view these files?
Response - Anyone
- 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 [mangavilliamrusha@gmail.com].
- For how long will this data be available start date provided 01-01-2027 and end date provided 01-01-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
All the pregnant woman including both primigravida and multigravida who have been admitted for induction of labor with no other contraindication for vaginal delivery will be assessed by their pre induction BISHOPS score Women with score < 6 will be taken into study after satisfying all the inclusion and exclusion criteria and after taking a detailed history and written informed consent. (10) Under strict aseptic precautions 22F foleys catheter will be inserted into cervix under direct visualization by holding the tip of the catheter with an artery forceps , bulb of the foleys catheter will be inflated with 20cc normal saline and the catheter will be gently pulled back so as to assure the tip of the catheter is beyond internal os and bulb is exactly at the level of internal os. Once the position of the catheter is confirmed the bulb will be further inflated with 40 cc of normal saline, a total of 60 cc of normal saline will be used for foley bulb inflation. Once the foley bulb is inflated,500cc warm normal saline(0.9% isotonic normal saline at room temperature) will be infused at the rate of 60cc/hr into the extra amniotic space through the catheter port via an infusion pump and back flow of the saline will be prevented by knotting the catheter at the rear end at the end of infusion. Then the catheter will be tied to the medial side of the thigh after creating the necessary traction. After spontaneous expulsion of foley’s catheter or after removal of foleys catheter after 24 hours of insertion, Post induction BISHOP’S score will be assessed and further methods of induction like PGE2 gel/ misoprostol/oxytocin will be decided based on the score. Only the guide/ co guide will do the pre and post induction BISHOPS scoring Patient blinding cannot be done. But the assessor ( guide/co-guide) will be blinded. Pre and post induction BISHOP will be assessed by the same person. Pharmacological agents will be used if post foleys bishops score still indicates an unfavorable cervix i.e., if the score is still ≤6, prostaglandins will be considered. If the score is ≥7 , oxytocin will be given for further induction(11) Induction - delivery interval, mode of delivery (normal vaginal delivery/ instrumental delivery/ c section), maternal and neonatal complications will be noted. |