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Preterm Labor, Premature Birth | Maintenance Gabapentin to Prolong Pregnancy.

Preterm Labor, Premature Birth research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Preterm Labor, Premature Birth

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Gabapentin

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Gabapentin

Study Status

Completed

Start Date: June 2013

Completed Date: August 2015

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: Rate of premature birth (before 37 weeks gestation)

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: University at Buffalo

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02056899

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