Maintenance Gabapentin to Prolong Pregnancy.

Overview[ - collapse ][ - ]

Purpose This is a pilot study to evaluate the tolerability and effects of maintenance gabapentin therapy on the rate of premature birth in women who have had preterm labor.
ConditionPreterm Labor, Premature Birth
InterventionDrug: Gabapentin
PhasePhase 1
SponsorUniversity at Buffalo
Responsible PartyUniversity at Buffalo
ClinicalTrials.gov IdentifierNCT02056899
First ReceivedJuly 30, 2013
Last UpdatedFebruary 5, 2014
Last verifiedFebruary 2014

Tracking Information[ + expand ][ + ]

First Received DateJuly 30, 2013
Last Updated DateFebruary 5, 2014
Start DateJune 2013
Estimated Primary Completion DateMarch 2016
Current Primary Outcome MeasuresRate of premature birth (before 37 weeks gestation) [Time Frame: At delivery] [Designated as safety issue: No]
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleMaintenance Gabapentin to Prolong Pregnancy.
Official TitleEffect of Maintenance Gabapentin Therapy on the Rate of Premature Birth in Women With Preterm Labor After Receiving Tocolysis.
Brief Summary
This is a pilot study to evaluate the tolerability and effects of maintenance gabapentin
therapy on the rate of premature birth in women who have had preterm labor.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 1
Study DesignEndpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
ConditionPreterm Labor, Premature Birth
InterventionDrug: Gabapentin
Other Names:
Neurontin
Study Arm (s)Experimental: Gabapentin

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment30
Estimated Completion DateMarch 2016
Estimated Primary Completion DateMay 2015
Eligibility Criteria
Eligibility 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.
GenderFemale
Ages18 Years
Accepts Healthy VolunteersNo
ContactsContact: Thomas Guttuso, Jr., MD
716-829-5454
tguttuso@buffalo.edu
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT02056899
Other Study ID Numbers423140-2
Has Data Monitoring CommitteeYes
Information Provided ByUniversity at Buffalo
Study SponsorUniversity at Buffalo
CollaboratorsNot Provided
Investigators Not Provided
Verification DateFebruary 2014

Locations[ + expand ][ + ]

University at Buffalo
Buffalo, New York, United States, 14214
Contact: Thomas Guttuso, Jr., MD
Principal Investigator: Thomas Guttuso, Jr., MD
Recruiting