Clinical Trial to evaluate the short duration treatment with Atosiban in Preterm Labor

Zuventus Healthcare Limited1 个研究点分布在 1 个国家目标入组 50 人开始时间: 2017年3月16日最近更新: 2023年4月19日

适应症

试验速览

Aim& Objectives:

The aim of this study is to establish efficacy, safety andtolerability of atosiban in treatment of preterm labor.

Primary Objective

The primary objective is to evaluate the efficacy ofatosiban in delaying impending preterm birth

Secondary Objective

Toevaluate the safety and tolerability of atosiban in Indian women

StudyDesign:

Prospective, Open-label, Non-comparative study

EstimatedSample Size:

50 completed patients

Study Outcomes:

Primary outcome:

Â· Proportion of womenremaining undelivered at 13 hrs after start of atosiban treatment

Â· Evaluation of timegained in utero after initiationof treatment

Â· Percentage reduction inuterine contractions from baseline

Â· Proportion of womenre-treated with atosiban

Â· Proportion of womenre-treated with alternative tocolytic agent

Secondary outcomes:

Â· Proportion of maternaland fetal adverse events reported during the study period

•1.Women â‰¥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 â‰¥ 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%.

•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.