CTRI/2017/03/008099
Completed
Phase 4
Clinical Trial to evaluate the short duration treatment with Atosiban in Preterm Labor
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: O600- Preterm labor without delivery
- Sponsor
- Zuventus Healthcare Limited
- Enrollment
- 50
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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