Health Condition 1: O60- Preterm labor Health Condition 2: O60- Preterm labor
Conditions
Interventions
Intervention1: Atosiban: 6.75mg atosiban intravenous bolus injection once given over 1 minute
Control Intervention1: Placebo: 0.9 ml intravenous bolus injection once given over 1 minute
Sponsors
Zuventus Healthcare Limited
Eligibility
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of time gained in utero after initiation of treatment for 48 hrsTimepoint: Till delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of safety and tolerabilityTimepoint: till delivery | — |
Countries
India
Contacts
Public ContactDr Bhupesh Dewan
Zuventus Healthcare Ltd
Outcome results
None listed