Status:
COMPLETED
Vaginal Progesterone for Prevention of Preterm Birth After an Episode of Preterm Labor
Lead Sponsor:
University Medical Centre Ljubljana
Collaborating Sponsors:
Slovenian Research Agency
Conditions:
Preterm Birth
Eligibility:
FEMALE
18-48 years
Phase:
NA
Brief 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 treatmen...
Eligibility Criteria
Inclusion
- Patients with singleton pregnancies at gestational ages 25+0 to 33+6 weeks after an episode of preterm labor, with cervical length ≤25mm:
- Patients presenting with signs and symptoms of preterm labor will be admitted and given the standard treatment for preterm labor, i.e. tocolysis for 48 hours, and antenatal steroids.
- Those who will remain undelivered for 48 hours and will be found to have a cervical length of 25mm or less will be offered entrance into the study.
- Preterm labor will be defined as at least 4 contractions in 30 minutes with cervical change assessed by digital cervical examination.
Exclusion
- Patients with preterm premature rupture of membranes (PPROM) will be excluded from the study, due to the possibility of ascending infection, as will those with suspected chorioamnionitis.
- We will not include multiple pregnancies.
- Patients with medical conditions that contraindicate tocolysis, such as non-reassuring fetal heart tracings, will also be excluded.
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01523483
Start Date
March 1 2012
End Date
March 1 2015
Last Update
April 22 2015
Active Locations (1)
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1
Univerity Medical Centre Ljubljana
Ljubljana, Slovenia, 1000