Pregnancy, Unwanted Clinical Trial
Official title:
A Randomized Trial of Mifepristone Antagonization With High-Dose Progesterone to Prevent Medical Abortion
Double-blind randomized trial to evaluate the potential impact of progesterone treatment on early pregnancies exposed to mifepristone.
Medical abortion commonly refers to early pregnancy termination (usually before 10 weeks'
gestation) performed without primary surgical intervention and resulting from the use of
abortion-inducing medications. The use of medications to cause abortion has been around for
almost 70 years but the modern era of medical abortion treatment evolved with the development
of mifepristone, a progesterone-receptor blocker with an affinity for the receptor greater
than progesterone itself.
Medical abortion with mifepristone and misoprostol is highly effective; however, the risk of
continuing pregnancy is still present, especially as gestation advances. While most women opt
for further treatment in these scenarios, such as surgical aspiration, there are some who
decide to continue the pregnancy. Thus, even following treatment, some women do change their
mind.
No well-done study has evaluated whether such treatment works. Poorly controlled case series
are not evidence and systematic reviews of continuing pregnancy rates after
mifepristone/prostaglandin analogue treatment failure do not reflect real life outcomes. This
study is also a first step to understanding if large studies evaluating mifepristone
antagonization with high-dose progesterone are indicated and if placebo-controlled randomized
trials can be successfully completed when evaluating this question.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Suspended |
NCT04830007 -
Factors Associated With the Absence of Contraception at Women Seeking a Voluntary Termination of Pregnancy
|
||
| Completed |
NCT02447029 -
Self-Administered Lidocaine Gel for Pain Management With First Trimester Surgical Abortion: A Randomized Controlled Trial
|
Phase 3 |