Health Condition 1: O30-O48- Maternal care related to the fetus and amniotic cavity and possible delivery problems
Conditions
Interventions
None listed
Sponsors
Abbott India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 Women with heart disease, pre-existing hypotension, and diabetes mellitus 4. Women with short cervix ( 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 hydrochlorideTimepoint: At the end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 hydrochlorideTimepoint: at the end of study | — |
Countries
India
Contacts
Public ContactSneha Nair
Abbott India Ltd
Outcome results
None listed