| CTRI Number |
CTRI/2025/03/082158 [Registered on: 11/03/2025] Trial Registered Prospectively |
| Last Modified On: |
01/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The study which compares the method for initiating the process of labour for pregnant women at term gestation with reduced liquor volume(oligohydramnios)
by Foley combined with single dose of Dinoprostone gel versus Foley with EASI - to study the successful vaginal delivery within 24 hour
|
|
Scientific Title of Study
|
Transcervical Foley catheter combined with a single dose of
Dinoprostone gel versus Extra amniotic saline infusion among Women
with Oligohydramnios undergoing Induction of Labour – A Randomised study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BSudharshana |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
OG OFFICE ,2 ND FLOOR, WCH, DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, JIPMER, PONDICHERRY
Pondicherry
PONDICHERRY
605006
India |
| Phone |
6369834104 |
| Fax |
|
| Email |
sudharshana334@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Niveditha Jha |
| Designation |
Associate professor |
| Affiliation |
JIPMER |
| Address |
OG OFFICE, 2 ND FLOOR, WCH, Department of Obstetrics and Gynaecology,JIPMER, PONDICHERRY
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9487581663 |
| Fax |
|
| Email |
dr.niveditajha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
BSudharshana |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
OG OFFICE 2 ND FLOOR, WCH, Department of Obstetrics and Gynaecology,JIPMER, PONDICHERRY
Pondicherry
PONDICHERRY
605006
India |
| Phone |
6369834104 |
| Fax |
|
| Email |
sudharshana334@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research,Dhanvantri Nagar, Gorimedu,Puducherry,India, 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, 605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sudharshana |
JIPMER |
WCH OPD, WCH Ward, WCH building,Department of Obstetrics and Gynaecology,Jipmer Campus, Dhanvantri Nagar, Gorimedu, Puducherry, India-605006
Pondicherry
PONDICHERRY |
6369834104
sudharshana334@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER , 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: O410||Oligohydramnios, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Induction of labour by Foley with Dinoprostone gel |
Pregnant women with Oligohydramnios at term gestation will be induced with Transcervical Foley along with single dose of Dinoprostone gel and will be monitored for achievement of favourable bishop score. If not, further other methods of induction like PGE1 or PGE2 gel will be used. The successful vaginal delivery within 24 hours of induction will be studied |
| Comparator Agent |
Induction of labour by Foley with Extra amniotic saline infusion |
Pregnant women with Oligohydramnios at term gestation will be induced with Foley and Extra amniotic saline infusion, which is the standard method for induction in Oligohydramnios. The patient will be monitored for the favourable bishop score achievement. We will compare the outcome successful vaginal delivery within 24 hours with the intervention group , to identify which group will be better for induction of pregnant women with Oligohydramnios |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women with Oligohydramnios (AFI less than or equal to 5)at 37 weeks of gestation with single live intrauterine fetus in cephalic presentation |
|
| ExclusionCriteria |
| Details |
1.Uterine scar
2.Foetal anomaly
3.Placental abruption
4.Stage 2 ,3 FGR
5.Severe Pre eclampsia
6.Overt Diabetes/ Uncontrolled Gestational Diabetes mellitus
7.Grand Multipara
8.Contraindication to vaginal delivery
9.Latex allergy / contraindication to Prostaglandins use |
|
|
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 women delivering within 24 hours of induction. Those delivering within 12 hours, beyond 24 hours will also be noted. |
At term gestation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Changes in Bishop score (Difference between pre induction Bishop & post ripening Bishop)
2.Induction Delivery Interval (IDI), measured as:
Duration of Foley insertion to spontaneous expulsion/removal
Duration of Foley expulsion/removal to delivery
3.Maternal satisfaction
4.Maternal & perinatal outcome |
At term gestation |
|
|
Target Sample Size
|
Total Sample Size="352"
Sample Size from India="352"
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)
|
15/03/2025 |
| 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
|
Labour induction is a frequently performed procedure in the management of high risk pregnancy. Induction is carried out generally when the risk of continuing pregnancy outweighs the benefit or at the request of pregnant women. There are many methods available for induction of labour, mechanical method(Foley catheter ) or medical methods( using Prostaglandins). Currently foley catheter is most commonly used mechanical method for labour induction, which acts not only as a mechanical dilator of cervix but also a stimulator of endogenous prostaglandins release from fetal membranes. Oligohydramnios(AFI<5) is one of the most common indication for induction of labour.
The study will be conducted in Women and Children Hospital of JIPMER in the Department of Obstetrics and Gynaecology. Pregnant women with Oligohydramnios at term gestation will be recruited as per the inclusion criteria from the antenatal ward. Informed consent will be obtained from the study subjects before recruitment , in the own language known to study subjects. Detailed history will be obtained from the subject as per the data collection proforma. All participants will be allocated to one of the two groups by Block Randomisation technique using SNOSE method. In the Intervention group, women will be Induced with Transcervical Foley catheter combined with single dose of Dinoprostone Gel. In the Control group , the women will be induced with Transcervical Foley catheter with Extra Amniotic Saline Infusion. For Foley catheter insertion, the patient will asked to lie down on bed in lithotomy position, Foley tube will inserted to cervix through the vagina and the balloon is inflated with saline water. For EASI, the saline will be infused through the Foley catheter at the rate of 100 ml/hr for 6 hours. This helps in separating the membranes and releases Prostaglandins to initiate the process of labour. Foley catheter will left inside for 24 hours if it is not spontaneously expelled. After expulsion of Foley catheter, Bishop score will be assessed. If the cervix is not favourable , further pharmacological agents like PGE1(Misoprostol) or PGE2 ( Dinoprostone gel ), will be used to make cervix favourable. Once the cervix becomes favourable, Oxytocin infusion will be given intravenously to induce Uterine contractions. After starting the process of induction, women will be continuously monitored in the Labour room. Fetal heart rate monitoring will be done. Therefore, in this study we are trying to find out whether Foley catheter combined with Dinoprostone gel will be effective than Foley with EASI for Induction of labour among pregnant women with Oligohydramnios. |