Gabapentin for Pain Control After Osmotic Dilator Insertion and Prior to D&E Procedure: a Randomized Controlled Trial

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.

Conditions

• Abortion, Induced
• Cervical Preparation
• Pain

Interventions

DRUG

Gabapentin 600mg

Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place)

DRUG

Placebo oral capsule

Packaged identical to gabapentin dosing

DRUG

acetaminophen/codeine and ibuprofen

Over the counter analgesic medications

Sponsors & Collaborators

• Society of Family Planning

  collaborator OTHER

• University of California, Davis

  lead OTHER

Principal Investigators

• Natasha Schimmoeller, MD, MPH, MA · University of California, Davis

• Mitchell Creinin, MD · University of California, Davis

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-03-20

Primary Completion

2018-11-05

Completion

2018-11-05

FDA Drug

Yes

Countries

• United States

Study Locations