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Vaginal Progesterone for Prevention of Preterm Birth After an Episode of Preterm Labor

Preterm Birth Clinical Trial

Official title:
Vaginal Progesterone for Prevention of Preterm Birth After an Episode of Preterm Labor

Clinical Trial Summary

The investigators study objective is to investigate the effectiveness of vaginal micronized progesterone in prolonging pregnancy after an episode of preterm labor which responded to tocolytic treatment. Furthermore, the investigators aim is to study the mechanisms of actions of progesterone supplementation by examining its effect on the two components of parturition: cervical ripening and myometrial contractility. The investigators will utilize transvaginal ultrasound to assess the changes in the cervical tissue, and non-invasive trans-abdominal uterine EMG to assess the uterine muscle activity. The investigators will also look at the effect of progesterone on contraction frequency by tocodynamometer (TOCO), though EMG is expected to provide much more information.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01523483
Study type Interventional
Source University Medical Centre Ljubljana
Contact
Status Completed
Phase N/A
Start date March 2012
Completion date March 2015
View Details
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