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Maintenance Gabapentin to Prolong Pregnancy.

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ClinicalTrials.gov Identifier: NCT02056899
Recruitment Status : Completed
First Posted : February 6, 2014
Last Update Posted : August 4, 2015
Sponsor:
Information provided by (Responsible Party):
Thomas Guttuso, University at Buffalo

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.

Condition or disease Intervention/treatment Phase
Preterm Labor, Premature Birth Drug: Gabapentin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Maintenance Gabapentin Therapy on the Rate of Premature Birth in Women With Preterm Labor After Receiving Tocolysis.
Study Start Date : June 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Gabapentin Drug: Gabapentin
Other Name: Neurontin



Primary Outcome Measures :
  1. Rate of premature birth (before 37 weeks gestation) [ Time Frame: At delivery ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056899


Locations
United States, New York
University at Buffalo
Buffalo, New York, United States, 14214
Sponsors and Collaborators
University at Buffalo

Responsible Party: Thomas Guttuso, Associate Professor of Neurology, University at Buffalo
ClinicalTrials.gov Identifier: NCT02056899     History of Changes
Other Study ID Numbers: 423140-2
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: August 4, 2015
Last Verified: August 2015

Keywords provided by Thomas Guttuso, University at Buffalo:
Preterm labor, premature birth, gabapentin

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Gabapentin
gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents