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

An Open-Label, Non - Comparative Phase-IV Study to Evaluate the Efficacy and Safety of Atosiban 7.5 mg/ml in Preterm Labor

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/03/008065

Enrollment

440

Registered

2017-03-14

Start date

Unknown

Completion date

Unknown

Last updated

2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O600- Preterm labor without delivery

Interventions

Intervention1: Atosiban: Atosiban 7.5 mg/ml Intravenous upto 48 hrs Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
1. Proportion of women remaining undelivered at 72hrs 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 Timepoint: till the time of delivery	—

Secondary

Measure	Time frame
1. Proportion of maternal and fetal adverse events reported during the study periodTimepoint: till the time of delivery	—

Countries

India

Contacts

Public ContactDr Bhupesh Dewan

Zuventus Healthcare Limited,

bhupesh.dewan@zuventus.com30610000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 16, 2026