Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
4 participants
INTERVENTIONAL
2013-06-30
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Gabapentin
Gabapentin
Interventions
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Gabapentin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Healthy 18-45 year old female with singleton pregnancy, 20-34 weeks gestation, without ruptured membranes.
2. Preterm labor defined as regular uterine contractions of at least 6/hour for ≥ 1 hour with ≥ 1cm of cervical dilation or ≤ 2.5cm cervical length or any documented cervical change from the initial pelvic exam.
3. Cervical dilation not more than 4cm.
4. Initiation of a tocolytic agent (e.g. magnesium sulfate, nifedipine, indomethacin) within the previous 72 hours.
5. Pregnancy not conceived through in-vitro fertilization (IVF) due to the known higher rates of congenital defects associated with this procedure.30
6. No placenta praevia or abruptio placentae or cervical cerclage.
7. No intra-uterine growth restriction or non-reassuring fetal status.
8. No known serious fetal malformations.
9. No chorioamnionitis or medical/psychiatric/substance abuse comorbidity that may complicate the pregnancy or interfere with the subject's ability to comply with study procedures in the opinion of Dr. Guttuso or the subject's obstetrician.
10. No history of suicide attempt. No suicidal thoughts over past 6 months.
11. Not currently receiving gabapentin, pregabalin, progesterone or a known teratogenic medication and no known allergy to gabapentin therapy.
18 Years
45 Years
FEMALE
No
Sponsors
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State University of New York at Buffalo
OTHER
Responsible Party
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Thomas Guttuso
Associate Professor of Neurology
Locations
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University at Buffalo
Buffalo, New York, United States
Countries
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Other Identifiers
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423140-2
Identifier Type: -
Identifier Source: org_study_id
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