| CTRI Number |
CTRI/2018/04/013262 [Registered on: 13/04/2018] Trial Registered Prospectively |
| Last Modified On: |
25/02/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate efficacy and safety of Isoxsuprine Hydrochloride in females with preterm labor. |
|
Scientific Title of Study
|
A Prospective, Single Center, Open-Label, Non-Comparative Study For Evaluation Of Efficacy And Safety Study Of Isoxsuprine Hydrochloride As Uterine Relaxant In Preterm Labor |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr P B Jaju |
| Designation |
HOD, Department of Obstetrics and Gynecology |
| Affiliation |
B. M. Patil Medical College Hospital and Research Centre, |
| Address |
B. M. Patil Medical College Hospital and Research Centre,
Dr B M Patil Road (Solapur Road)
Vijayapura(Bijapur),
Bijapur
KARNATAKA
586103
India |
| Phone |
|
| Fax |
|
| Email |
p.b.jaju@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P B Jaju |
| Designation |
HOD, Department of Obstetrics and Gynecology |
| Affiliation |
B. M. Patil Medical College Hospital and Research Centre, |
| Address |
B. M. Patil Medical College Hospital and Research Centre,
Dr B M Patil Road (Solapur Road)
Vijayapura(Bijapur),
Bijapur
KARNATAKA
586103
India |
| Phone |
|
| Fax |
|
| Email |
p.b.jaju@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P B Jaju |
| Designation |
HOD, Department of Obstetrics and Gynecology |
| Affiliation |
B. M. Patil Medical College Hospital and Research Centre, |
| Address |
B. M. Patil Medical College Hospital and Research Centre,
Dr B M Patil Road (Solapur Road)
Vijayapura(Bijapur),
Bijapur
KARNATAKA
586103
India |
| Phone |
|
| Fax |
|
| Email |
p.b.jaju@gmail.com |
|
|
Source of Monetary or Material Support
|
| Abbott India Limited, Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr PB Jaju |
| Address |
Head of department,
Department of Obstetrics and Gynecology,
B. M. Patil Medical College Hospital and Research Centre,
Dr B M Patil Road (Solapur Road)
Vijayapura(Bijapur)-586103,
Karnataka, India |
| Type of Sponsor |
Other [Principal Investigator ] |
|
|
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 PB jaju |
B. M. Patil Medical College Hospital and Research Centre |
Dr B M Patil Road (Solapur Road)
Vijayapura(Bijapur)-586103,
Bijapur
KARNATAKA |
9845241315
p.b.jaju@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BLDE Institutional Ethic Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Preterm labor, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A.Isoxsuprine hydrochloride injection I.P.-Each ml contains Isoxsuprine Hydrochloride IP 5 mg
B.Isoxsuprine hydrochloride 40mg sustained release capsule.
|
All study participants will be given a loading dose of Intravenous infusion of Isoxsuprine hydrochloride injection 40 mg (four ampoules) in 500 ml of 5% dextrose giving a concentration of 0.8 mg/ml, to be continued over 12 hours after uterine quiescence. The infusion will be discontinued if any adverse effect develops.
After 15 minutes of stoppage of infusion, intramuscular injection of Isoxsuprine hydrochloride 10 mg/ 4 hourly will be given up to first 24-hours of hospitalization.
Subsequently, Isoxsuprine hydrochloride 40mg sustained release capsule will be prescribed twice daily as maintenance therapy for next 24-hours, and the patient will be kept on the same dose till the time of the delivery. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Gestational age 24-37 weeks
2.Regular uterine contractions, 2 or more than 2 per 20 minutes each lasting for at least 20 seconds
3.Cervical dilatation less than 3 cm
4.Cervical effacement less than 50%.
5.Intact membrane
|
|
| ExclusionCriteria |
| Details |
1.Antepartum hemorrhage
2.Fetal malformations
3.Pregnancy with heart disease and diabetes mellitus
4.Multiple pregnancies
5.Hydramnios
6.Prolonged PROM
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Percentage of patients with Isoxsuprine hydrochloride injection having successful tocolysis in first 24 hours.
2.Percentage of patients with Isoxsuprine hydrochloride Retard 40mg capsule having successful tocolysis in next 24 hours.
|
Baseline (0 Hour)
24-Hours
48-Hours
Time of delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Percentage of patients with adverse effects during first 24 hours of Isoxsuprine hydrochloride injection therapy.
2.Percentage of patients with adverse effects during maintenance therapy with Isoxsuprine hydrochloride Retard 40mg capsule.
3.Maternal Latency period after usage of Isoxsuprine hydrochloride as tocolytic agent in the management of preterm labor.
4.Fetal Apgar Score (1 min and 5 min) after usage of Isoxsuprine hydrochloride as tocolytic agent in the management of preterm labor. |
Baseline (0 Hour)
24-Hours
48-Hours
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)
Modification(s)
|
14/04/2018 |
| Date of Study Completion (India) |
31/08/2018 |
| 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
Modification(s)
|
The results of this study are published :
Jaju PB. Effectiveness and Safety of Isoxsuprine Hydrochloride as Tocolytic Agent in Arresting Active/Threatened Preterm Labor and Its Role in Maintenance Tocolysis-A Prospective, Open-Label Study.Am J Perinatol. 2019 Sep 24. doi: 10.1055/s-0039-1696720. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a prospective, single center, open-label, non-comparative study designed to evaluate effectiveness and safety of Isoxsuprine hydrochloride as a uterine relaxant in preterm labor. The study population will include patients with preterm labor, admitted at the study site and are clinically indicated for the treatment with Isoxsuprine hydrochloride, as per the discretion of treating physician. All study participants will be given a loading dose of intravenous infusion of Isoxsuprine hydrochloride four (4) ampoules (40 mg) in 500 ml of 5% dextrose giving a concentration of 0.8 mg/ml. Drop rate will be set at 8 drops/minute (0.04 mg/minute). The drop rate will be increased by 8 drops/minute after every 15-minutes until uterine quiescence is attained, or patient develops adverse effects like maternal tachycardia (heart rate >130/minute) or hypotension (systolic blood pressure <80 mmHg or diastolic blood pressure <40 mmHg), or intolerable nausea and vomiting or foetal tachycardia (foetal heart rate >160 beats/minute). The infusion will be discontinued if any adverse effect develops, otherwise, intravenous infusion will be continued over next 12 hours after uterine quiescence. After 15 minutes of stoppage of infusion, intramuscular injection of Isoxsuprine hydrochloride 10 mg/ 4 hourly will be given up to first 24-hours of hospitalization. Subsequently, Isoxsuprine hydrochloride 40mg sustained release capsule will be prescribed twice daily as maintenance therapy for next 24-hours, and the patient will be kept on the same dose till the time of the delivery. Treatment will be considered successful if the uterine quiescence was maintained for at least 48 hours. If the sign of preterm labor recurs, parenteral therapy as described above will be started. Adverse effects reported or observed will also be recorded. Treatment will be discontinued if the patient experiences intolerable side effects requiring discontinuation of the therapy. Otherwise, the patient will be prescribed Isoxsuprine hydrochloride 40mg sustained release capsule, twice daily as maintenance therapy till the time of delivery. |