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Maintenance Gabapentin to Prolong Pregnancy.

Primary Purpose

Preterm Labor, Premature Birth

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Gabapentin

About this trial

This is an interventional prevention trial for Preterm Labor, Premature Birth focused on measuring Preterm labor, premature birth, gabapentin

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Eligibility Criteria:

Healthy 18-45 year old female with singleton pregnancy, 20-34 weeks gestation, without ruptured membranes.
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.
Cervical dilation not more than 4cm.
Initiation of a tocolytic agent (e.g. magnesium sulfate, nifedipine, indomethacin) within the previous 72 hours.
Pregnancy not conceived through in-vitro fertilization (IVF) due to the known higher rates of congenital defects associated with this procedure.30
No placenta praevia or abruptio placentae or cervical cerclage.
No intra-uterine growth restriction or non-reassuring fetal status.
No known serious fetal malformations.
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.
No history of suicide attempt. No suicidal thoughts over past 6 months.
Not currently receiving gabapentin, pregabalin, progesterone or a known teratogenic medication and no known allergy to gabapentin therapy.

Sites / Locations

University at Buffalo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gabapentin

Arm Description

Outcomes

Primary Outcome Measures

Rate of premature birth (before 37 weeks gestation)

Secondary Outcome Measures

Full Information

NCT ID

NCT02056899

First Posted

July 30, 2013

Last Updated

February 10, 2023

Sponsor

State University of New York at Buffalo

1. Study Identification

Unique Protocol Identification Number

NCT02056899

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.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

June 2013 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

State University of New York at Buffalo

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Preterm Labor, Premature Birth

Keywords

Preterm labor, premature birth, gabapentin

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gabapentin

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Gabapentin

Other Intervention Name(s)

Neurontin

Primary Outcome Measure Information:

Title

Rate of premature birth (before 37 weeks gestation)

Time Frame

At delivery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Eligibility Criteria: Healthy 18-45 year old female with singleton pregnancy, 20-34 weeks gestation, without ruptured membranes. 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. Cervical dilation not more than 4cm. Initiation of a tocolytic agent (e.g. magnesium sulfate, nifedipine, indomethacin) within the previous 72 hours. Pregnancy not conceived through in-vitro fertilization (IVF) due to the known higher rates of congenital defects associated with this procedure.30 No placenta praevia or abruptio placentae or cervical cerclage. No intra-uterine growth restriction or non-reassuring fetal status. No known serious fetal malformations. 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. No history of suicide attempt. No suicidal thoughts over past 6 months. Not currently receiving gabapentin, pregabalin, progesterone or a known teratogenic medication and no known allergy to gabapentin therapy.

Facility Information:

Facility Name

University at Buffalo

City

Buffalo

State/Province

New York

ZIP/Postal Code

14214

Country

United States

12. IPD Sharing Statement

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