| CTRI Number |
CTRI/2017/03/008099 [Registered on: 15/03/2017] Trial Registered Prospectively |
| Last Modified On: |
19/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
short duration treatment with atosiban an intravenous medication as a labour repressant (tocolytic) to halt premature labor. |
|
Scientific Title of Study
|
Clinical Trial to evaluate the short duration treatment with Atosiban in Preterm Labor |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ZUV/TOSI/HQ/10/2016 Version No 1 Version Date 12/10/2016 |
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 |
| Address |
Lokmanya Tilak Municipal General Hospital
and Lokmanya Tilak Municipal Medical College, 1 st floor, Department of obstetric 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 estaes, chandivali, andheri east
Mumbai
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 estaes, chandivali, andheri east
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 Estate Chandivali Andheri East Mumbai 400072 |
|
|
Primary Sponsor
|
| Name |
Zuventus Healthcare Limited |
| Address |
office no 5119 D wing 5th floor oberoi garden estaes, chandivali andheri east mumbai |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Rahul Mayekar |
Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College |
College Building, 1st floor, Department of Gynecology and Obstetrics, sion , Mumbai 400022
Mumbai
MAHARASHTRA |
9869876266
rvmayekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 13hrs |
| 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
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Proportion of women remaining undelivered at 13 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
|
1.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="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
16/03/2017 |
| Date of Study Completion (India) |
27/09/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
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
The primary objective is to evaluate the efficacy of
atosiban in delaying impending preterm birth
Secondary Objective
To
evaluate the safety and tolerability of atosiban in Indian women
Study
Design:
Prospective, Open-label, Non-comparative study
Estimated
Sample Size:
50 completed patients Study Outcomes: Primary outcome: ·
Proportion of women
remaining undelivered at 13 hrs after start of atosiban treatment ·
Evaluation of time
gained in utero after initiation
of treatment ·
Percentage reduction in
uterine contractions from baseline ·
Proportion of women
re-treated with atosiban ·
Proportion of women
re-treated with alternative tocolytic agent Secondary outcomes:
·
Proportion of maternal
and fetal adverse events reported during the study period
|