CTRI/2017/11/010518CompletedPhase 4
An Open-Label, placebo controlled Study to Evaluate the Efficacy and Safety of Atosiban 6.75 mg/0.9ml in Preterm Labor
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Zuventus Healthcare Limited
- Enrollment
- 75
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •Women =18 years of age
- •Gestational age from 24 until 33 completed weeks which has been documented by a definite LMP or sonography in the first trimester
- •Women with preterm labor.
- •The diagnosis of preterm labor requires the presence of uterine contractions with or without cervical changes
Exclusion Criteria
- •Women with any of the following:
- •Chorioamnionitis
- •Preterm rupture of membranes
- •Vaginal bleeding
- •Eclampsia and severe pre-eclampsia requiring delivery
- •Intrauterine growth restriction
- •Intrauterine fetal death
- •Congenital or acquired uterine malformation
- •Severe placental insufficiency
- •Placenta previa and abruptio placentae
- •Fetal distress
- •Women who are otherwise judged inappropriate for inclusion in the study by the investigator.
Investigators
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