Skip to content

Maintenance Gabapentin to Prolong Pregnancy.

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02056899
Enrollment
4
Registered
2014-02-06
Start date
2013-06-30
Completion date
2015-08-31
Last updated
2023-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Labor, Premature Birth

Keywords

Preterm labor, premature birth, gabapentin

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.

Interventions

DRUGGabapentin

Sponsors

State University of New York at Buffalo
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frame
Rate of premature birth (before 37 weeks gestation)At delivery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026