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
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  DR MANJU  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 Contact Person Scientific Query	Name  Dr AMITA SUNEJA  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 Contact Person Public Query	Name  Dr AMITA SUNEJA  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	self sponsored
Primary Sponsor Modification(s)	Name  UCMS and GTB Hospital  Address  UCMS and GTB Hospital, dilshad garden delhi 95  Type of Sponsor  Government medical college
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  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   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	Status  Not Applicable
Health Condition / Problems Studied Modification(s)	Health Type  Condition  Patients  PRETERM LABOUR
Intervention / Comparator Agent Modification(s)	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 Modification(s)	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 Modification(s)	Outcome  TimePoints  birth weight  nil  early neonatal mortality  nil  neonatal morbidity  nil  NICU admission rate  nil  number of pretem birth  nil  readmission for preterm labour  NIL
Target Sample Size	Total Sample Size="90" Sample Size from India="90"
Phase of Trial	N/A
Date of First Enrollment (India)	02/12/2010
Date of First Enrollment (Global)	No Date Specified
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
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