| CTRI Number |
CTRI/2020/07/026333 [Registered on: 02/07/2020] Trial Registered Prospectively |
| Last Modified On: |
29/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Process of Care Changes |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of Oral Mifepristone on an out-patient basis to aid onset of normal labour pain in low risk pregnant women more than 40 weeks of gestation |
|
Scientific Title of Study
|
Efficacy of Oral Mifepristone for Cervical Ripening and Induction of Labour on an out-patient basis in low risk pregnant women with past dates |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Elza Rebecca Kharsyntiew |
| Designation |
PG Registrar |
| Affiliation |
Christian Medical College Vellore |
| Address |
Obstetrics and Gynaecology
Unit III
Christian Medical College
Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
8056766394 |
| Fax |
|
| Email |
elrekh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anuja Abraham |
| Designation |
Associate Professor |
| Affiliation |
Christian Medical College Vellore |
| Address |
Head of Unit III
Obstetrics and Gynaecology
Christian Medical College
Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
9486543840 |
| Fax |
|
| Email |
anuja@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Elza Rebecca Kharsyntiew |
| Designation |
PG Registrar |
| Affiliation |
Christian Medical College Vellore |
| Address |
Obstetrics and Gynaecology
Unit III
Christian Medical College
Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
8056766394 |
| Fax |
|
| Email |
elrekh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Internal Fluid Research,
Christian Medical College, Vellore |
|
|
Primary Sponsor
|
| Name |
Internal Fluid Research |
| Address |
Christian Medical College
Vellore 632004
Tamil Nadu |
| 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 |
| Elza Rebecca Kharsyntiew |
Christian Medical College, Vellore |
Out patient Department (OPD), Department of Obstetrics and Gynaecology Unit III
Christian Medical College and Hospital,Vellore 632004
Vellore
TAMIL NADU |
8056766394
elrekh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board of Christian Medical College, Vellore |
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 |
| Comparator Agent |
NIL (NOT APPLICABLE) |
NIL |
| Intervention |
Oral Mifepristone 200mg |
Patients who fit in the inclusion and exclusion criteria will be consented to take part in the study. Non stress test will be performed prior to Induction. Patients with non reactive NST will be excluded from the study. Oral Mifepristone 200mg will be given after a per-vaginal examination has been done. Patient will be sent home and asked to come back for admission after 48 hours or earlier if onset of labour sets in. Danger signs will be explained to the patient and will be asked to review before 48 hours if she has regular pain / leaking or bleeding per-vaginum or decreased fetal movements |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women at term (>40 weeks and above) with singleton pregnancy in cephalic presentation |
|
| ExclusionCriteria |
| Details |
1.Previous LSCS
2.Hypertension, pre-eclampsia
3.IUGR, oligohydraminos
4.Diabetes on Insulin
5.Low lying placenta
6.Chorioamnionitis or rupture of membranes
7.Bishop score more than 6 at the time of enrolment
8.Non- reactive NST
9.Intra-uterine foetal death
10.Any contraindication for vaginal delivery (e.g., cephalo-pelvic disproportion) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Rate of successful vaginal delivery
2. Improvement in Bishop’s score after 48 hours of induction or at the time of onset of labour |
1. Rate of successful vaginal delivery
2. Improvement in Bishop’s score after 48 hours of induction or at the time of onset of labour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a. Maternal
1.Need / Number of doses of Misoprostol required on admission
2.Need and dose of oxytocin for augmentation of labour
3.ARM to delivery interval
4.Maternal Morbidity – ICU admissions, Blood transfusions (if any)
b.FOETAL
1.CS for NRFS / Failed induction
2.APGAR SCORE at 5 and 10 minutes
3.Neonatal intensive care unit (NICU) admissions |
72 hours |
|
|
Target Sample Size
|
Total Sample Size="188"
Sample Size from India="188"
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 3 |
|
Date of First Enrollment (India)
|
01/08/2020 |
| 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="1"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Plan to publish in an indexed journal after final analysis |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Induction of labour is indicated for various reasons (maternal and foetal). A successful vaginal delivery requires the presence of a favourable cervix and hence before any method of induction, cervical assessment is essential. Mifeprstone (RU 486) is a steroid that has antiprogesterone properties. The most commonly approved indications for use of Mifepristone in obstetrics are termination of early pregnancy, labour induction in case of foetal death in uterus. It causes softening and dilatation of the cervix and also results in an increase in uterine cavity. This effect, observed in various clinical studies reduced the doses of prostaglandins needed, and shortened the time necessary for expulsion of foetus in termination of pregnancies. Therefore, the aim of this study is to evaluate the efficacy of a single dose of mifepristone for cervical ripening and induction of labour at term. Those women more than 40 weeks and planned for induction of labour who consent to the study will be given one dose of Oral Mifepristone (200mg) 48 hours prior to the date of induction of labour. NST will be taken and the patient will be sent home. They will be adviced to come back for routine induction after 48 hours or earlier if they have spontaneous pain, leaking PV or decreased foetal movements. A re- assessment per vaginal examination will be done after 48 hours or earlier if the onset of labour has taken place. The primary outcome will be to calculate the rate of vaginal delivery and improvement in Bishop’s score after 48 hours or earlier if onset of labour has taken place. The secondary outcomes will be to assess the need for augmentation with oxytocin, number of patients who needed misoprostol for induction, number of doses of misoprostol required, intrapartum complications such as hyperstimulation and other CTG abnormalities. Foetal complications such as APGAR score at 5 and 10 minutes, meconium aspiration, low cord pH and NICU admissions. |