A Study to find out the Effectiveness andSafety of Isoxsuprine Hydrochloride in Women with Preterm Labor in India
Completed
- Conditions
- Maternal care related to the fetus and amniotic cavity and possible delivery problems,
- Registration Number
- CTRI/2020/01/022643
- Lead Sponsor
- Abbott India Ltd
- 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 afterdeidentification will be made available in the form of publication (text,tables, figures and appendices). Data will be available for anyone who wishesto access the publication.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 245
Inclusion Criteria
- 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.
Exclusion Criteria
- 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).
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method hydrochloride At the end of study Number and percentage of women achieving successful tocolysis (total suppression of At the end of study labor, i.e., no contractions) at 24 hours and 48 hours of start of therapy with isoxsuprine At the end of study
- Secondary Outcome Measures
Name Time Method 1. Safety a. Number and percentage of women with ADRs, tabulated by system organ class and
Trial Locations
- Locations (4)
ACSR Government Medical College
🇮🇳Nellore, ANDHRA PRADESH, India
Government Medical College and Hospital
🇮🇳Aurangabad, MAHARASHTRA, India
Lokmanya Tilak Municipal Medical College
🇮🇳Mumbai, MAHARASHTRA, India
Sudbhawana Hospital
🇮🇳Varanasi, UTTAR PRADESH, India
ACSR Government Medical College🇮🇳Nellore, ANDHRA PRADESH, IndiaDr Mary SnygdhaPrincipal investigator7981034760abhigoody1@gmail.com