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Completed

NCT Number: NCT02056899

Maintenance Gabapentin to Prolong Pregnancy.

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.

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Key information

Conditions

Preterm Labor, Premature Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

University at Buffalo

Buffalo, New York, 14214, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gabapentin

Drug

Other names: Neurontin

Primary outcomes

  1. Rate of premature birth (before 37 weeks gestation)

    Time frame: At delivery

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 6, 2014
Registry last updated
Feb 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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