| CTRI Number |
CTRI/2011/10/002043 [Registered on: 11/10/2011] Trial Registered Retrospectively |
| Last Modified On: |
14/04/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
effect of oral micronized progesterone for prolongation of pregnancy in arrested preterm labour |
|
Scientific Title of Study
|
ORAL MICRONIZED PROGESTERONE FOR MAINTENANCE TOCOLYSIS AFTER ARRESTED PRETERM LABOUR- A RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR MANJU |
| Designation |
Post graduate student |
| Affiliation |
ucms and GTB hospital |
| Address |
Dept of obs and gynae
UNIVERSITY COLLEGE OF MEDICAL SCIENCES NEW DELHI
DELHI 110095
INDIA
New Delhi
DELHI
110095
India |
| Phone |
9868482424 |
| Fax |
|
| Email |
manjuchodhary04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr AMITA SUNEJA |
| Designation |
Professor |
| Affiliation |
ucms and GTB hospital |
| Address |
Dept of obs and gynae
UNIVERSITY COLLEGE OF MEDICAL SCIENCES NEW DELHI
DELHI 110095
INDIA
New Delhi
DELHI
110095
India |
| Phone |
9868399728 |
| Fax |
|
| Email |
amita_suneja@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr AMITA SUNEJA |
| Designation |
Professor |
| Affiliation |
ucms and GTB hospital |
| Address |
Dept of obs and gynae
UNIVERSITY COLLEGE OF MEDICAL SCIENCES NEW DELHI
DELHI 110095
INDIA
New Delhi
DELHI
110095
India |
| Phone |
9868399728 |
| Fax |
|
| Email |
amita_suneja@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
UCMS and GTB Hospital |
| Address |
UCMS and GTB Hospital, dilshad garden delhi 95 |
| 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 MANJU |
GTB Hospital,Labour room |
Dept of obs and gynae,UCMS and GTB hospital -110095
new delhi
New Delhi
DELHI |
9868482424
manjuchodhary04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee-human research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
PRETERM LABOUR, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ORAL MICRONIZED PROGESTERONE |
Cap MICRONIZED PROGESTERONE 200mg OD given orally from time of recruitment till 37 weeks of gestation or delivery whichever is earlier. |
| Comparator Agent |
PLACEBO Capusules |
The comparator arm will receive only placebo and will not receive any active drug.Placebo consists of similar looking capsules with lactose as filler.Lactose is completely inert and harmless substance.Placebo will be given once daily from time of recruitment till 37 weeks of gestation or delivery whichever is earlier |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
.Only those Pregnant women between 24-34 weeks
period of gestation with preterm labour pain
.Singleton pregnancy
.Intact membrane |
|
| ExclusionCriteria |
| Details |
.Multiple pregnancy
.Premature rupture of membranes
.Antepartum hemorrhage
.Fetal growth restriction/gross congenital anomalies
.Severe maternal illness
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| prolongation of pregnancy |
NIL |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| readmission for preterm labour |
NIL |
| number of pretem birth |
nil |
| birth weight |
nil |
| NICU admission rate |
nil |
| neonatal morbidity |
nil |
| early neonatal mortality |
nil |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/12/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The study is a randomized double blind placebo controlled trial which aims to evaluate the efficacy of maintenance therapy with oral micronized progesterone for prolongation of pregnancy in cases of arrested preterm labour.The study is being conducted at GTB hospital and UCMS delhi.The primary outcome is prolongation of pregnancy |