Atosiban an intravenous medication as a labour repressant (tocolytic) to halt premature labor.

Phase 4

Completed

Conditions: Preterm labor without delivery,

Registration Number: CTRI/2017/03/008065

Lead Sponsor: Zuventus Healthcare Limited

Brief Summary: **Aim & Objectives**

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

**Primary Objective**

1. The primary objective is to evaluate the efficacy of atosiban in delaying impending preterm birth

**Secondary Objective**

1. To evaluate the safety and tolerability of atosiban in Indian women

**Study Design:**

Prospective, Open-label, Multicentric, Non-comparative study

**Study Outcomes:**

**Primary outcome:**

**1.**Proportion of women remaining undelivered at 72 hrs after start of atosiban treatment

2. Evaluation of time gained *in utero* after initiation of treatment

3. Percentage reduction in uterine contractions from baseline

4. Proportion of women re-treated with atosiban

5. Proportion of women re-treated with alternative tocolytic agent

**Secondary outcomes:**

**1.**Proportion of maternal and fetal adverse events reported during the study period

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 440

Inclusion Criteria

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%.

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

Primary Outcome Measures

Name	Time	Method
1. Proportion of women remaining undelivered at 72hrs after start of atosiban treatment	till the time of delivery
2. Evaluation of time gained in utero after initiation of treatment	till the time of delivery
3. Percentage reduction in uterine contractions from baseline	till the time of delivery
4. Proportion of women re-treated with atosiban	till the time of delivery
5. Proportion of women re-treated with alternative tocolytic agent	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 (14): All India Institute of Medical Sciences
🇮🇳
Delhi, DELHI, India
Government Medical College & Government General Hospital (Old RIMSGGH),
🇮🇳
Srikakulam, ANDHRA PRADESH, India
Government Medical College and Hospital
🇮🇳
Nagpur, MAHARASHTRA, India
GVSM Medical College
🇮🇳
Nagar, UTTAR PRADESH, India
Health Point Hospital
🇮🇳
Kolkata, WEST BENGAL, India
Institute of Post Gradutae Medical Education and Research
🇮🇳
Kolkata, WEST BENGAL, India
Janta Hospital and Maternity
🇮🇳
Varanasi, UTTAR PRADESH, India
Jubilee Mission Medical College
🇮🇳
Thrissur, KERALA, India
K R Hospital
🇮🇳
Mysore, KARNATAKA, India
Kempegowda Institute of Medical Sciences
🇮🇳
Bangalore, KARNATAKA, India
Scroll for more (4 remaining)
All India Institute of Medical Sciences
🇮🇳Delhi, DELHI, India
Dr Alka Kriplani
Principal investigator
09810828717
kriplanialka@gmail.com