| CTRI Number |
CTRI/2019/01/017054 [Registered on: 11/01/2019] Trial Registered Prospectively |
| Last Modified On: |
30/03/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Experience with Atosiban
|
|
Scientific Title of Study
|
Our initial experience with Atosiban for preterm labour in a tertiary care centre
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Col Dr Reema Kumar Bhatt |
| Designation |
Senior Advisor |
| Affiliation |
Army Research and Referral Hospital |
| Address |
Ground floor, Department of Obstetrics and Gynaecology, Near Subroto Park, Dhaula Kuan
New Delhi
DELHI
110 010
India |
| Phone |
9205646811 |
| Fax |
|
| Email |
reemakamalbhatt@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Col Dr Reema Kumar Bhatt |
| Designation |
Senior Advisor |
| Affiliation |
Army Research and Referral Hospital |
| Address |
Ground floor, Department of Obstetrics and Gynaecology, Near Subroto Park, Dhaula Kuan
New Delhi
DELHI
110 010
India |
| Phone |
9205646811 |
| Fax |
|
| Email |
reemakamalbhatt@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Col Dr Reema Kumar Bhatt |
| Designation |
Senior Advisor |
| Affiliation |
Army Research and Referral Hospital |
| Address |
Ground floor, Department of Obstetrics and Gynaecology, Near Subroto Park, Dhaula Kuan
New Delhi
DELHI
110 010
India |
| Phone |
9205646811 |
| Fax |
|
| Email |
reemakamalbhatt@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Army Research and Referral Hospital, Military Hospital Road Near, Subroto Park, Dhaula Kuan, New Delhi, Delhi 110010 |
|
|
Primary Sponsor
|
| Name |
Army Research and Referral Hospital |
| Address |
Near, Subroto Park, Dhaula Kuan, New Delhi, Delhi 110010 |
| 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 |
| Lt Col Dr Reema Kumar Bhatt |
Army Research and Referral Hospital |
Ground floor, Department of Obstetrics and Gynaecology, Military Hospital Road Near, Subroto Park, Dhaula Kuan
New Delhi
DELHI |
9205646811
reemakamalbhatt@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Army Hospital (R & R) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O600||Preterm labor without delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Atosiban 7.5 mg/ml |
Atosiban as intravenous (i.v.) infusion for 48 hours in three successive stages. The treatment will be initiated by an initial bolus dose (6.75 mg) administered over 1 min, then continuous high dose infusion (300 mcg/min) for period of 3 hours followed by 100 mcg/min upto 48 hrs.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
All patients with preterm labour Singleton/ multi fetal gestation beyond 24weeks of gestation to
33 weeks + 6 days with intact amniotic membranes |
|
| ExclusionCriteria |
| Details |
1. All patients with preterm rupture of membranes
2. All patients of abruptio placenta
3. All patients less than 24 weeks of gestation
4. All patients more than 34 weeks of gestation
5. All patients with fever , tachycardia and positive CRP in maternal blood on admission
6. All patients with IUD /congenital anomaly
7. Patients needing more than one tocolytic agent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients who will be undelivered upto 72 hours after completion of treatment phase and those not delivered till the end of 7 days |
Throughout study duration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Perinatal death.
2.Mode of delivery.
3.Emergency caesarean (if any)
|
At the time of delivery |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/01/2019 |
| Date of Study Completion (India) |
01/02/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet published. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Objectives: To sudy the efficacy of atosiban in established cases of preterm labour Validity of better symptomatic results and better fetal outcome after the treatment with inj. Atosiban
Study design: Prospective clinical trial
Inclusion criteria: All patients with preterm labour singleton / multifetal gestation beyond 24 weeks of gestation to 33 weeks + 06 days with intact amniotic membranes
Exclusion criteria: All patients with preterm rupture of membranes All patients of abruptio placenta All patients less than 24 weeks of gestation All patients more than 34 weeks of gestation All patients with fever, tachycardia and positive CRP in maternal blood on admission All patients with IUD/congenital anomaly Patients needing more than one tocolytic agent
Primary outcome: . The primary outcome will be undelivered up to 72 hrs after completion of treatment phase and those not delivered till the end of their hospital stay (upto 7 days).
Secondary outcomes: Perinatal death Mode of delivery Emergency Cesarean (if any) |