| CTRI Number |
CTRI/2020/01/022643 [Registered on: 07/01/2020] Trial Registered Prospectively |
| Last Modified On: |
11/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Post Marketing Observational Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to find out the Effectiveness and
Safety of Isoxsuprine Hydrochloride in Women with Preterm Labor in India |
|
Scientific Title of Study
|
A Prospective, Multicenter, Open-label, Single-arm Study to Assess the Effectiveness and
Safety of Isoxsuprine Hydrochloride in Women with Preterm Labor in India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shilpa Nandkumar Naik |
| Designation |
Assistant Professor Obs and Gynae |
| Affiliation |
BJ Government Medical College and Sassoon Hospitals |
| Address |
Dept of Gynac and Obs. OPD No. 63 First floor BJ Government Medical College and Sassoon Hospitals,Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
|
| Fax |
|
| Email |
shilunnaik@yahoo.co.in |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Shivani Acharya |
| Designation |
Associate Director Clinical Development and Operations |
| Affiliation |
Abbott India Ltd |
| Address |
Floor 16, Godrej BKC, Plot No. C – 68, BKC, Near
MCA Club, Bandra (E),Mumbai
Mumbai
MAHARASHTRA
4000051
India
Mumbai
MAHARASHTRA
4000051
India |
| Phone |
|
| Fax |
|
| Email |
shivani.acharya@abbott.com |
|
Details of Contact Person
Public Query
|
| Name |
Sneha Nair |
| Designation |
Head Clinical Operations |
| Affiliation |
Abbott India Ltd |
| Address |
Floor 16, Godrej BKC, Plot No. C – 68, BKC, Near
MCA Club, Bandra (E),Mumbai
Mumbai
MAHARASHTRA
4000051
India
Mumbai
MAHARASHTRA
4000051
India |
| Phone |
|
| Fax |
|
| Email |
sneha.nair@abbott.com |
|
Source of Monetary or Material Support
Modification(s)
|
|
Primary Sponsor
Modification(s)
|
| Name |
Abbott India Ltd |
| Address |
3, Corporate Park, Sion Trombay Road, Mumbai – 400 071, Maharashtra, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mary Snygdha |
ACSR Government Medical College |
Department of General Medicine, AC Subbareddy Govt Medical College and Hospital,Opp A.C. Stadium, Dargamitta, G.T.Road,Nellore-524004, Andhra Pradesh
Nellore
ANDHRA PRADESH |
7981034760
abhigoody1@gmail.com |
| Dr Shrinivas NGadappa |
Government Medical College and Hospital |
OPD No 114 and 115, Dept. of OB/GYN, Govt. Medical College & Hospital, Near Panchakki Road,
Aurangabad, Pin:431001
Aurangabad
MAHARASHTRA |
9822441553
gadappashrinivas@gmail.com |
| Dr Arun Nayak |
Lokmanya Tilak Municipal Medical College |
Department of Obstetrics and Gynecology, Babasaheb Ambedkar Road, Sion, Mumbai - 400022, Maharashtra.
Mumbai
MAHARASHTRA |
9821313315
drarunhnayak@hotmail.com |
| Dr Pragya Pandey |
Sudbhawana Hospital |
Sudbhawana Hospital, B31/80,23B,Bhogabir, Lanka, Varanasi-221005,Uttar Pradesh,India
Varanasi
UTTAR PRADESH |
9696519115
pragyamadhukar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee Human Research, Lokmanya Tilak Municipal Medical College and General Hospital |
Approved |
| Institutional Ethics Committee. Govt College Aurangabad. |
Approved |
| Sudbhawana Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O30-O48||Maternal care related to the fetus and amniotic cavity and possible delivery problems, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
1. Women ≥18 years old with singleton or twin pregnancy of 24 to 37 weeks of gestation
2. Women with ≥1 contractions per 10 minutes, each lasting for at least 20 seconds with or
without cervical dilatation ≤ 4 cm
3. Women willing and able to provide informed consent for participation in the study
4. A woman in whom decision to prescribe isoxsuprine hydrochloride (Duvadilan by Abbott
India Limited) (according to the local label) for PTL has been taken by the physician
during the routine practice |
|
| ExclusionCriteria |
| Details |
1. Women with premature rupture of membranes
2. Women with cervical dilatation > 4 cm and /or ≥ 4 contractions per 10 minutes
3. Women with Systolic Blood Pressure <100 and /or Pulse rate >100 Women with heart
disease, pre-existing hypotension, and diabetes mellitus
4. Women with short cervix (<25 mm)
5. Women with history of hypersensitivity to tocolysis
6. Women with high-risk pregnancy (history of recent cerebral hemorrhage, antepartum
hemorrhage, intrauterine fetal death, lethal fetal anomalies, chorioamnionitis, hydramnios,
cervical trauma including surgery like previous cone knife or laser, large loop excision of
the transformation zone, radical diathermy) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Number and percentage of women achieving successful tocolysis (total suppression of
labor, i.e., no contractions) at 24 hours and 48 hours of start of therapy with isoxsuprine
hydrochloride |
At the end of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Safety
a. Number and percentage of women with ADRs, tabulated by system organ class and
preferred term, corresponding severity (per Common Terminology Criteria for
Adverse Events [CTCAE] v 5.0), relationship to isoxsuprine hydrochloride
b. Number and percentage of women with ADRs leading to discontinuation of
isoxsuprine hydrochloride |
at the end of study |
|
|
Target Sample Size
|
Total Sample Size="245"
Sample Size from India="245"
Final Enrollment numbers achieved (Total)= "170"
Final Enrollment numbers achieved (India)="170" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2020 |
| Date of Study Completion (India) |
03/05/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a post marketing observational study where we intend to find out the effectiveness and safety of Isoxsuprine Hydrochloride patients of preterm labor. This is a multi center PMOS study to be conducted at approx 5 government centers in India. Participant data collected during the trial after
deidentification will be made available in the form of publication (text,
tables, figures and appendices). Data will be available for anyone who wishes
to access the publication. |