Gabapentin for Pain Control After Osmotic Dilator Insertion and Prior to D&E Procedure: a Randomized Controlled Trial
Status:
Completed
Trial end date:
2018-11-05
Target enrollment:
Participant gender:
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.