Gabapentin for Pain Control After Osmotic Dilator Insertion and Prior to D&E Procedure: a Randomized Controlled Trial
Condition: Abortion, Induced; Cervical Preparation; Pain
Intervention: Gabapentin 600mg; Placebo oral capsule; acetaminophen/codeine and ibuprofen
Intervention description: Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place); Packaged identical to gabapentin dosing; Over the counter analgesic medications
Intervention MeSH terms: Acetaminophen; Ibuprofen; Gabapentin; Codeine; Carboxymethylcellulose Sodium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized placebo controlled trial, stratified block randomization based on prior vaginal parity (vaginal parity - yes or no). Goal of even distribution of prior vaginal parity between gabapentin and placebo groups as may impact osmotic dilator pain experience
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 121.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Abortion; Osmotic dilators; Gabapentin; Text message

Summary:

      Women having abortion procedures between 15 weeks 0 days and 23 weeks 6 days gestational age
      on the day of their procedure commonly have dilators placed in their cervix overnight before
      the abortion procedure. The dilators are put in during a pelvic exam in the clinic and after
      women go home they expand slowly overnight to open the cervix before the abortion procedure
      the next day. This can be a painful experience and health care providers often give women
      different kinds of pain medicine to help them.

      The investigators are interested in whether a medicine called gabapentin, which is a
      non-narcotic medicine, could help. Gabapentin is approved by the U.S. Food and Drug
      Administration (FDA) for prevention of seizures and for treating nerve pain and doctors are
      also using it to decrease pain for people having surgical procedures.

      The main goals of our study are to learn about:

        1. Women's pain experience with dilators in their cervix overnight before the abortion
           procedure

        2. How well gabapentin works to decrease women's pain while they have the dilators in their
           cervix

      Women who enroll in the study will get a dose of either gabapentin or placebo (a pill with no
      medicine in it) before their dilators are placed in the clinic. The medication they get
      (gabapentin or placebo) will be chosen by chance, like flipping a coin. Neither the women in
      the study nor the doctors giving them the medication will know which medication they receive
      so the investigators can learn about their pain without being influenced by knowing which
      medication they take. Doctors will be able to find out which medication women got if there is
      an emergency or if it changes their medical care.

      The investigators will communicate with women in real time overnight by text messaging to see
      how much pain they are having in the moment and how much pain medicine they are taking.

      The investigators hypothesize that women who receive gabapentin will have a smaller increase
      in their pain with the dilators than women who receive placebo (a pill with no medicine in
      it).

      The investigators' findings will help doctors understand women's pain experience with
      dilators better and possibly provide a new way of treating pain with gabapentin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  15 weeks 0 days gestational age - 23 weeks 5 days gestational age at time of dilator
             insertion

          -  Able to read and write in English

          -  Active cell phone with text messaging capability

          -  Ride home from dilator insertion clinic appointment

        Exclusion Criteria:

          -  Current use of gabapentin or pregabalin

          -  Allergy to gabapentin, acetaminophen, codeine, or ibuprofen

          -  Self reported renal disease (severe impaired renal function)

          -  Self reported current or chronic narcotic use (typical daily use)

          -  Women with any issue that, in the opinion of the investigator, would interfere with
             study participation or generating accurate study data