| CTRI Number |
CTRI/2017/03/008065 [Registered on: 14/03/2017] Trial Registered Prospectively |
| Last Modified On: |
19/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Atosiban an intravenous medication as a labour repressant (tocolytic) to halt premature labor. |
|
Scientific Title of Study
|
An Open-Label, Non - Comparative Phase-IV Study to Evaluate the Efficacy and Safety of Atosiban 7.5 mg/ml in Preterm Labor |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ZUV/TOSI/HQ/11/2015 date 24/11/2015 number 1.0 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rahul Mayekar |
| Designation |
Principal Investigator |
| Affiliation |
Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College, Sion Mumbai |
| Address |
Lokmanya Tilak Municipal General Hospital
and Lokmanya Tilak Municipal Medical College, 1st floor, Department of Obstetrics and Gynaecology,Sion Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9869876266 |
| Fax |
|
| Email |
rvmayekar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhupesh Dewan |
| Designation |
Sponsor |
| Affiliation |
Zuventus Healthcare Limited, |
| Address |
Zuventus Healthcare Limited, Office no 5119, D wing, 5th floor, Oberoi Garden Estates, Chandivali, Andheri East
Mumbai (Suburban)
MAHARASHTRA
400072
India |
| Phone |
30610000 |
| Fax |
|
| Email |
bhupesh.dewan@zuventus.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhupesh Dewan |
| Designation |
Sponsor |
| Affiliation |
Zuventus Healthcare Limited, |
| Address |
Zuventus Healthcare Limited, Office no 5119, D wing, 5th floor, Oberoi Garden Estates, Chandivali, Andheri East
Mumbai (Suburban)
MAHARASHTRA
400072
India |
| Phone |
30610000 |
| Fax |
|
| Email |
bhupesh.dewan@zuventus.com |
|
|
Source of Monetary or Material Support
|
| Zuventus Healthcare Limited
office number 5119 D wing 5th Floor Oberoi Garden estaes Chandivali Andheri East mumbai 400072 |
|
|
Primary Sponsor
|
| Name |
Zuventus Healthcare Limited |
| Address |
Office no. 5119, D wing, 5th Floor, Obroi Garden Estaes, Chandivali, |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 14 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Alka Kriplani |
All India Institute of Medical Sciences |
3rd floor, Department of Obstetrics & Gynecology, New Delhi-l10029
New Delhi
DELHI |
09810828717
kriplanialka@gmail.com |
| Dr Isukapalli Vani |
Government Medical College & Government General Hospital (Old RIMSGGH), |
Department of Gynaecology,
Srikakulam, Andhra Pradesh
532 001
Srikakulam
ANDHRA PRADESH |
9346627652
drivaniggh@yahoo.com |
| Dr Rujuta Fuke |
Government Medical College and Hospital |
Ground floor,Department of Obstetrics and Gynecology, Near Hanuman Nagar Nagpur-440009
Nagpur
MAHARASHTRA |
0712-2750145
rujutafuke@yahoo.com |
| Dr Neena Gupta |
GVSM Medical College |
Department Of Gynecology and Obstetrics, Swaroop Nagar, Kanpur, Uttar Pradesh 208002
Kanpur Nagar
UTTAR PRADESH |
9415131422
drneenagupta.reseach@gmail.com |
| Dr Sambhunath Bandyopadhyay |
Health Point Hospital |
Department of Gynecology and Obstetrics,
#21, Prannath Pandit Street,
Opp. Lansdowne, Paddapukur,
Kolkata 700 025
Kolkata
WEST BENGAL |
9830083861
drsnbcal@gmail.com |
| Dr Gaurishankar Kamilya |
Institute of Post Gradutae Medical Education and Research |
Department of Obstretics and Gynaecology,244, Acharya Jagdish Chandra Bose Road,Kolkatta 700020
Kolkata
WEST BENGAL |
9433122643
drgkamilya@gmail.com |
| Dr Vani Bajpai |
Janta Hospital and Maternity |
Near water head tank, Amara Akhari Bypass, Chunar road, Varanasi- 221011
Varanasi
UTTAR PRADESH |
9839708367
vanivns@gmail.com |
| Dr Aswath Kumar |
Jubilee Mission Medical College |
Department of Obstetrics & Gynaecology,
Bishop Alappatt Road,
Jubliee Mission P.O.,
Thrissur East- 680005, Kerala
Thrissur
KERALA |
9847316519
draswath@gmail.com |
| Dr Lakshmikantha Govindappa |
K R Hospital |
Irwin road, Devaraja Mohalla,opp Mysore Medical College and Research Institute, Mysore 570001
Mysore
KARNATAKA |
9740810611
gdrlakshmikantha@gmail.com |
| Dr Sowmya K |
Kempegowda Institute of Medical Sciences |
Athibabbe Road, Near BDA Complex, Banashankari 2nd Stage, Bengaluru, Karnataka 560070
Bangalore
KARNATAKA |
9448167679
drsowmyagopinath@gmail.com |
| Dr Sujata Deo |
King Georges Medical University |
Faculty block, Room no. 6, Department of Obstetrics and Gynecology Shah Mina Road, Chowk, Lucknow, Uttar Pradesh 226003
Lucknow
UTTAR PRADESH |
9415152570
drsujata.2008@rediffmail.com |
| Dr Rahul Mayekar |
Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College |
College Building 1st floor Gynecology and obstetric department Dr. Babasaheb Ambedkar Road, Sion West, Mumbai, Maharashtra 400022
Mumbai
MAHARASHTRA |
9869876266
rvmayekar@gmail.com |
| Dr Subhankar Dasgupta |
Rampurhat Government Medical College |
Department of Gynecology and Obstetrics,
Rampurhat Government Medical College,
Birbhum West Bengal,
India- 731224
Birbhum
WEST BENGAL |
9874836437
subhankar74@gmail.com |
| Dr Farzana M Ahmed |
Santosh Hospital |
#6/1 Promenade Road, Behind Coles Park, Near Good Will School, Bengaluru 560005
Bangalore
KARNATAKA |
9845084911
080-40848866
guideline801@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 14 |
| Name of Committee |
Approval Status |
| Ethics committee GSVM Medical College |
Approved |
| Health Point Ethics Committee |
Approved |
| IEC Govt Medical college and Gen Hospital |
Approved |
| Institutional Ethics Committee AIIMS |
Approved |
| Institutional Ethics Committee for human Research, Rampurhat |
Approved |
| Institutional Ethics Committee Government Medical College and Hospital |
Approved |
| Institutional Ethics Committee King Georges Medical College |
Approved |
| Institutional Ethics Committee, Jubilee Mission Medical College |
Approved |
| Institutional Ethics Committee, Mysore Medical college and Research Institute |
Approved |
| IPGMER Research Oversight Committee |
Approved |
| Janta Hospital Ethics Committee |
Approved |
| KIMS Institutional Ethics Committee |
Approved |
| Medisys Clinisearch Ethical Review Board |
Approved |
| Staff and Research Society LTMMC&GH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O600||Preterm labor without delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Atosiban |
Atosiban 7.5 mg/ml
Intravenous upto 48 hrs |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Women ≥18 years of age
2.Gestational age from 24 until 33 completed weeks which has been documented by a definite LMP or sonography in the first trimester
3.Women with preterm labor. The diagnosis of preterm labor requires the presence of ≥ 4 uterine contractions over 30 minutes, each lasting at least 30 seconds, and documented cervical change. Criteria for cervical changes are defined as follows:
a.Nulliparous women: a single cervical examination demonstrating dilatation of 0 cm to 3 cm and effacement of at least 50%
b.Multiparous women: a single cervical examination demonstrating dilatation of 1 cm to 3 cm and effacement of at least 50%.
|
|
| ExclusionCriteria |
| Details |
1.Women with any of the following:
a.Chorioamnionitis
b.Preterm rupture of membranes
c.Vaginal bleeding
d.Eclampsia and severe pre-eclampsia requiring delivery
e.Intrauterine growth restriction
f.Intrauterine fetal death
g.Congenital or acquired uterine malformation
h.Severe placental insufficiency
i.Placenta previa and abruptio placentae
2.Fetal distress
3.Women who are otherwise judged inappropriate for inclusion in the study by the investigator.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Proportion of women remaining undelivered at 72hrs after start of atosiban treatment
2. Evaluation of time gained in utero after initiation of treatment
3. Percentage reduction in uterine contractions from baseline
4. Proportion of women re-treated with atosiban
5. Proportion of women re-treated with alternative tocolytic agent
|
till the time of delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Proportion of maternal and fetal adverse events reported during the study period |
till the time of delivery |
|
|
Target Sample Size
|
Total Sample Size="440"
Sample Size from India="440"
Final Enrollment numbers achieved (Total)= "440"
Final Enrollment numbers achieved (India)="440" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
16/03/2017 |
| Date of Study Completion (India) |
28/01/2022 |
| 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)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aim & Objectives The aim of this study is to establish efficacy, safety and tolerability of atosiban in treatment of preterm labor. Primary Objective 1. The primary objective is to evaluate the efficacy of atosiban in delaying impending preterm birth Secondary Objective 1. To evaluate the safety and tolerability of atosiban in Indian women Study Design: Prospective, Open-label, Multicentric, Non-comparative study Study Outcomes: Primary outcome: 1. Proportion of women remaining undelivered at 72 hrs after start of atosiban treatment 2. Evaluation of time gained in utero after initiation of treatment 3. Percentage reduction in uterine contractions from baseline 4. Proportion of women re-treated with atosiban 5. Proportion of women re-treated with alternative tocolytic agent Secondary outcomes: 1. Proportion of maternal and fetal adverse events reported during the study period |