A Study to find out the Effectiveness andSafety of Isoxsuprine Hydrochloride in Women with Preterm Labor in India
- Conditions
- Health Condition 1: O30-O48- 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
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 170
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
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)
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber and percentage of women achieving successful tocolysis (total suppression of <br/ ><br>labor, i.e., no contractions) at 24 hours and 48 hours of start of therapy with isoxsuprine <br/ ><br>hydrochlorideTimepoint: At the end of study
- Secondary Outcome Measures
Name Time Method 1. Safety <br/ ><br>a. Number and percentage of women with ADRs, tabulated by system organ class and <br/ ><br>preferred term, corresponding severity (per Common Terminology Criteria for <br/ ><br>Adverse Events [CTCAE] v 5.0), relationship to isoxsuprine hydrochloride <br/ ><br>b. Number and percentage of women with ADRs leading to discontinuation of <br/ ><br>isoxsuprine hydrochlorideTimepoint: at the end of study