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. |
---|---|
Condition | Preterm Labor, Premature Birth |
Intervention | Drug: Gabapentin |
Phase | Phase 1 |
Sponsor | University at Buffalo |
Responsible Party | University at Buffalo |
ClinicalTrials.gov Identifier | NCT02056899 |
First Received | July 30, 2013 |
Last Updated | February 5, 2014 |
Last verified | February 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | July 30, 2013 |
---|---|
Last Updated Date | February 5, 2014 |
Start Date | June 2013 |
Estimated Primary Completion Date | March 2016 |
Current Primary Outcome Measures | Rate of premature birth (before 37 weeks gestation) [Time Frame: At delivery] [Designated as safety issue: No] |
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | Maintenance Gabapentin to Prolong Pregnancy. |
---|---|
Official Title | Effect 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 Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 1 |
Study Design | Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention |
Condition | Preterm Labor, Premature Birth |
Intervention | Drug: Gabapentin Other Names: Neurontin |
Study Arm (s) | Experimental: Gabapentin |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
---|---|
Estimated Enrollment | 30 |
Estimated Completion Date | March 2016 |
Estimated Primary Completion Date | May 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. |
Gender | Female |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Thomas Guttuso, Jr., MD 716-829-5454 tguttuso@buffalo.edu |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT02056899 |
---|---|
Other Study ID Numbers | 423140-2 |
Has Data Monitoring Committee | Yes |
Information Provided By | University at Buffalo |
Study Sponsor | University at Buffalo |
Collaborators | Not Provided |
Investigators | Not Provided |
Verification Date | February 2014 |
Locations[ + expand ][ + ]
University at Buffalo | Buffalo, New York, United States, 14214 Contact: Thomas Guttuso, Jr., MDPrincipal Investigator: Thomas Guttuso, Jr., MD Recruiting |
---|