An Open-labeled, Non - comparative Clinical trial to evaluate the Efficacy and Tolerability of Atosiban in the Preterm Labour

Phase 3

Completed

Conditions: Health Condition 1: O60- Preterm labor

Registration Number: CTRI/2013/11/004166

Lead Sponsor: Zuventus Healthcare Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 110

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

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 ( < 5th percentile).

f.Non-reassuring fetal heart rate

g.Maternal contraindications

i.Chronic hypertension

ii. Systolic blood pressure < 90 mmHg

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1. Proportion of women remaining undelivered at 24 48 and 72 hrs of treatment <br/ ><br>2. Proportion of women who did not receive an alternative tocolytic within 48 and 72 hrs <br/ ><br>2. Proportion of women re-treated with Atosiban <br/ ><br>3. Proportion of women receiving a full course of steroids <br/ ><br>Satisfaction of women at discharge <br/ ><br>Timepoint: at the end of 72 hrs