Maintenance Gabapentin to Prolong Pregnancy.

February 10, 2023 updated by: Thomas Guttuso, State University of New York at Buffalo

Effect of Maintenance Gabapentin Therapy on the Rate of Premature Birth in Women With Preterm Labor After Receiving Tocolysis.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14214
        • University at Buffalo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Gabapentin
Drug: Gabapentin
Other Names:
  • Neurontin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of premature birth (before 37 weeks gestation)
Time Frame: At delivery
At delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York at Buffalo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ACTUAL)

August 1, 2015

Study Completion (ACTUAL)

August 1, 2015

Study Registration Dates

First Submitted

July 30, 2013

First Submitted That Met QC Criteria

February 5, 2014

First Posted (ESTIMATE)

February 6, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

February 10, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 423140-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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