Health Condition 1: O60- Preterm labor
Conditions
Interventions
Intervention1: Atosiban: Atosiban 7.5 mg/ml
Atosiban is administered intravenously in three successive stages:
â?¢an initial bolus dose (6.75mg), performed with Atosiban 7.5mg/ml solution for injecti
Sponsors
Zuventus Healthcare Ltd
Emcure Pharmaceutical Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women >18 years of age 2. Gestational age between 24 to 34 weeks which has been documented by a definite LMP and sonography up to 20 weeks. 3. Women with preterm labor. The diagnosis of preterm labor required the presence of 4 uterine contractions or more over 30 minutes, each lasting at least 30 seconds, and documented cervical change. The cervical criteria were met when either of the following was present: Nulliparous women: a single cervical examination demonstrating dilatation of 0 cm to 4 cm and effacement of at least 50% Multiparous women: a single cervical examination demonstrating dilatation of 1 cm to 4 cm and effacement of at least 50%. 4. Provision of written informed consent
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to the active substance 2. Women with any of the following: a.Chorioamnionitis b.Preterm rupture of membranes c.Vaginal bleeding d.Severe hypertensive disorders e.Intrauterine growth restriction ( f.Non-reassuring fetal heart rate g.Maternal contraindications i.Chronic hypertension ii. Systolic blood pressure iii.Cardiovascular disease iv. Elevated hepatic enzymes h.Congenital or acquired uterine malformation 3. Women who are otherwise judged inappropriate for inclusion in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome in the study is the proportion of women remaining undelivered and not requiring an alternative tocolyticTimepoint: The primary outcome in the study is the proportion of women remaining undelivered and not requiring an alternative tocolytic | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of women remaining undelivered at 24 48 and 72 hrs of treatment 2. Proportion of women who did not receive an alternative tocolytic within 48 and 72 hrs 2. Proportion of women re-treated with Atosiban 3. Proportion of women receiving a full course of steroids Satisfaction of women at discharge Timepoint: at the end of 72 hrs | — |
Countries
India
Contacts
Public ContactDr Bhupesh Dewan
Zuventus Healthcare Ltd
Outcome results
None listed