short duration treatment with atosiban an intravenous medication as a labour repressant (tocolytic) to halt premature labor.

Phase 4

Completed

• Conditions: Health Condition 1: O600- Preterm labor without delivery

• Registration Number: CTRI/2017/03/008099
• Lead Sponsor: Zuventus Healthcare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-09-27
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

1.Women >=18 years of age

2.Gestational age from 24 until 33 completed weeks which has been documented by a definite LMP or sonography in the first trimester

3.Women with preterm labor. The diagnosis of preterm labor requires the presence of >= 4 uterine contractions over 30 minutes, each lasting at least 30 seconds, and documented cervical change. Criteria for cervical changes are defined as follows:

a.Nulliparous women: a single cervical examination demonstrating dilatation of 0 cm to 3 cm and effacement of at least 50%

b.Multiparous women: a single cervical examination demonstrating dilatation of 1 cm to 3 cm and effacement of at least 50%.

Exclusion Criteria

1.Women with any of the following:

a.Chorioamnionitis

b.Preterm rupture of membranes

c.Vaginal bleeding

d.Eclampsia and severe pre-eclampsia requiring delivery

e.Intrauterine growth restriction

f.Intrauterine fetal death

g.Congenital or acquired uterine malformation

h.Severe placental insufficiency

i.Placenta previa and abruptio placentae

2.Fetal distress

3.Women who are otherwise judged inappropriate for inclusion in the study by the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified