Atosiban (6.75 mg) injection to delay preterm birth
Phase 4
Completed
- Conditions
- Health Condition 1: O60- Preterm laborHealth Condition 2: O60- Preterm labor
- Registration Number
- CTRI/2017/11/010518
- Lead Sponsor
- Zuventus Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 75
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of time gained in utero after initiation of treatment for 48 hrsTimepoint: Till delivery
- Secondary Outcome Measures
Name Time Method Evaluation of safety and tolerabilityTimepoint: till delivery