short duration treatment with atosiban an intravenous medication as a labour repressant (tocolytic) to halt premature labor.
- Conditions
- Preterm labor without delivery,
- Registration Number
- CTRI/2017/03/008099
- Lead Sponsor
- Zuventus Healthcare Limited
- Brief Summary
**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:**
· Proportion of womenremaining undelivered at 13 hrs after start of atosiban treatment
· Evaluation of timegained *in utero* after initiationof treatment
· Percentage reduction inuterine contractions from baseline
· Proportion of womenre-treated with atosiban
· Proportion of womenre-treated with alternative tocolytic agent
**Secondary outcomes:**
· Proportion of maternaland fetal adverse events reported during the study period
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 50
- 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%.
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
- Primary Outcome Measures
Name Time Method 1. Proportion of women remaining undelivered at 13 hrs after start of atosiban treatment 1.till the time of delivery 2. Evaluation of time gained in utero after initiation of treatment 1.till the time of delivery 3. Percentage reduction in uterine contractions from baseline 1.till the time of delivery 4. Proportion of women re-treated with atosiban 1.till the time of delivery 5. Proportion of women re-treated with alternative tocolytic agent 1.till the time of delivery
- Secondary Outcome Measures
Name Time Method 1. Proportion of maternal and fetal adverse events reported during the study period till the time of delivery
Trial Locations
- Locations (1)
Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College
🇮🇳Mumbai, MAHARASHTRA, India
Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College🇮🇳Mumbai, MAHARASHTRA, IndiaDr Rahul MayekarPrincipal investigator9869876266rvmayekar@gmail.com