Maintenance Gabapentin to Prolong Pregnancy.

NCT02056899 | Completed Phase 1 DMC

• 1 other identifier: 423140-2
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Labor, Premature Birth

Keywords

Preterm labor, premature birth, gabapentin

Outcome Measures

Primary Outcomes (1)

• Rate of premature birth (before 37 weeks gestation)

  At delivery

Study Arms (1)

Gabapentin

EXPERIMENTAL

Drug: Gabapentin

Interventions

Gabapentin DRUG

Also known as: Neurontin

Gabapentin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

University at Buffalo

Buffalo, New York, 14214, United States

Location

MeSH Terms

Conditions

Obstetric Labor, Premature; Premature Birth

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: July 30, 2013
• First Posted: February 6, 2014
• Study Start: June 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: February 14, 2023

Record last verified: 2023-02

Locations

US (1)