| CTRI Number |
CTRI/2013/11/004166 [Registered on: 22/11/2013] Trial Registered Retrospectively |
| Last Modified On: |
24/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An Open-labeled, Non - comparative Clinical trial to evaluate the Efficacy and Tolerability of Atosiban in the Preterm Labour |
|
Scientific Title of Study
|
An Open-labeled, Non - comparative Clinical trial to evaluate the Efficacy and Tolerability of Atosiban in the Preterm Labour |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ZUV/ATOS/HQ/10/2010 Version: 1.1 Date: 5 december 2011 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Y Nandanwar |
| Designation |
Principal Investigator |
| Affiliation |
LTMMC AND LTMGH SION |
| Address |
Lokmanya Tilak Municipal Medical College & General Hospital
College building, Dept. of Gynecology
Dr. Babasaheb Ambedkar Road
Sion (West)
Mumbai - 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
|
| Fax |
|
| Email |
drnandanwar@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhupesh Dewan |
| Designation |
Director Medical Services |
| Affiliation |
Zuventus Healthcare Ltd |
| Address |
OFFICE NO 5119 D WING OBEROI GARDEN ESTATE CHANDIVALI ANDHERI EAST
Mumbai
MAHARASHTRA
400072
India |
| Phone |
|
| Fax |
|
| Email |
bhupesh.dewan@zuventus.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhupesh Dewan |
| Designation |
Director Medical Services |
| Affiliation |
Zuventus Healthcare Ltd |
| Address |
OFFICE NO 5119 D WING OBEROI GARDEN ESTATE CHANDIVALI ANDHERI EAST
MAHARASHTRA
400072
India |
| Phone |
|
| Fax |
|
| Email |
bhupesh.dewan@zuventus.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Zuventus Healthcare Ltd |
| Address |
office no5119 Oberoi Garden Estate Chandivilli Mumbai 400 072
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Emcure Pharmaceutical Ltd |
Emcure House
T 184 M.I.D.C.
Bhosari Pune 411 026. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nandanwar |
Lokmanya Tilak Municipal Medical College & General Hospital |
Department of Gynecology
Dr. Babasaheb Ambedkar Road
Sion (West)
Mumbai 400022
Mumbai
MAHARASHTRA |
09869072622
drnandanwar@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE HUMAN RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O60||Preterm labor, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Atosiban |
Atosiban 7.5 mg/ml
Atosiban is administered intravenously in three successive stages:
•an initial bolus dose (6.75mg), performed with Atosiban 7.5mg/ml solution for injection,
•immediately followed by a continuous high dose infusion (loading infusion 300μg/min) of Atosiban 7.5mg/ml concentrate for solution for infusion during three hours,
•followed by a lower dose of Atosiban 7.5mg/ml concentrate for solution for infusion (subsequent infusion 100μg/min) up to 45 hours.
The duration of the treatment should not exceed 48 hours. The total dose given during a full course of Atosiban therapy should preferably not exceed 330mg of the active substance.
|
| Comparator Agent |
not applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Women >18 years of age
2. Gestational age between 24 to 34 weeks which has been documented by a definite LMP and sonography up to 20 weeks.
3. Women with preterm labor. The diagnosis of preterm labor required the presence of 4 uterine contractions or more over 30 minutes, each lasting at least 30 seconds, and documented cervical change. The cervical criteria were met when either of the following was present:
Nulliparous women: a single cervical examination demonstrating dilatation of 0 cm to 4 cm and effacement of at least 50%
Multiparous women: a single cervical examination demonstrating dilatation of 1 cm to 4 cm and effacement of at least 50%.
4. Provision of written informed consent
|
|
| ExclusionCriteria |
| Details |
1. Known hypersensitivity to the active substance
2. Women with any of the following:
a.Chorioamnionitis
b.Preterm rupture of membranes
c.Vaginal bleeding
d.Severe hypertensive disorders
e.Intrauterine growth restriction (< 5th percentile).
f.Non-reassuring fetal heart rate
g.Maternal contraindications
i.Chronic hypertension
ii. Systolic blood pressure < 90 mmHg
iii.Cardiovascular disease
iv. Elevated hepatic enzymes
h.Congenital or acquired uterine malformation
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 |
| The primary outcome in the study is the proportion of women remaining undelivered and not requiring an alternative tocolytic |
The primary outcome in the study is the proportion of women remaining undelivered and not requiring an alternative tocolytic |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Proportion of women remaining undelivered at 24 48 and 72 hrs of treatment
2. Proportion of women who did not receive an alternative tocolytic within 48 and 72 hrs
2. Proportion of women re-treated with Atosiban
3. Proportion of women receiving a full course of steroids
Satisfaction of women at discharge
|
at the end of 72 hrs |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
29/03/2012 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Dewan B, Shah D. The Clinical Experience of Atosiban in Preterm Labour. British Journal of Medicine and Medical Research. 2016 Jan 1;13(7):1. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
An Open-labeled,
Non-Comparative Clinical trial to Evaluate the Efficacy and Tolerability of Atosiban
in the Preterm Labour. Phase III Atosiban
is used in the clinical setting for the treatment of preterm labour (PTL) since
1981. Atosiban is recommended by the Royal College of Obstetricians and
Gynecologists as a first line agent in the management of preterm labor. The
rationale for Atosiban’s development was based on producing a novel compound
that mimicked normal physiological processes with high uterine specificity, but
with limited or no systemic effects. The efficacy and safety of Atosiban in
clinical trials conducted globally on over 2000 women suggest that Atosiban has
proven benefit in the treatment of PTL and fares better than the available
tocolytics with its distinctive advantage of the least incidence of maternal
and fetal side effects. Considering the importance
of evaluation of treatment success in real-life clinical practice in Indian
setting, the current study was conducted to establish the efficacy and safety
of Atosiban (7.5 mg/ml) in the Indian patient population. A follow-up of all
patients till the time of discharge was conducted wherein the delivery status
and adverse events (if any) after treatment completion were assessed. |