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Trial record 18 of 153 for:    Open Studies | "Obstetric Labor, Premature"

Maintenance Gabapentin to Prolong Pregnancy.

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University at Buffalo
Sponsor:
Information provided by (Responsible Party):
Thomas Guttuso, University at Buffalo
ClinicalTrials.gov Identifier:
NCT02056899
First received: July 30, 2013
Last updated: February 5, 2014
Last verified: February 2014
  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 Intervention Phase
Preterm Labor, Premature Birth
Drug: Gabapentin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by University at Buffalo:

Primary Outcome Measures:
  • Rate of premature birth (before 37 weeks gestation) [ Time Frame: At delivery ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gabapentin Drug: Gabapentin
Other Name: Neurontin

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02056899

Contacts
Contact: Thomas Guttuso, Jr., MD 716-829-5454 tguttuso@buffalo.edu

Locations
United States, New York
University at Buffalo Recruiting
Buffalo, New York, United States, 14214
Contact: Thomas Guttuso, Jr., MD         
Principal Investigator: Thomas Guttuso, Jr., MD         
Sponsors and Collaborators
University at Buffalo
  More Information

No publications provided

Responsible Party: Thomas Guttuso, Associate Professor of Neurology, University at Buffalo
ClinicalTrials.gov Identifier: NCT02056899     History of Changes
Other Study ID Numbers: 423140-2
Study First Received: July 30, 2013
Last Updated: February 5, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 24, 2014