Maintenance Gabapentin to Prolong Pregnancy.

Preterm Labor, Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02056899
• Other study ID #: 423140-2
• Status: Completed
• Phase: Phase 1
• Start date: June 2013
• Est. completion date: August 2015

Study information

• Verified date: February 2023
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Labor, Premature Birth

Intervention

Drug:
• Gabapentin

Locations

Country	Name	City	State
United States	University at Buffalo	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of premature birth (before 37 weeks gestation)		At delivery