Spontaneous Abortion Clinical Trial
Official title:
The Effects of Aspirin in Gestation and Reproduction: A Multi-center, Controlled, Double-blind Randomized Trial.
The primary objective of the study is to help elucidate the effects of low-dose aspirin in combination with folic acid on the incidence of live births and spontaneous abortions among a group of women who become pregnant compared to a control group.
Despite the fundamental nature of reproduction, for many it is a process fraught with
frustration, inefficiency and imperfections, the effects of which can be severe. Infertility
affects 10-15% of couples attempting to conceive. Among all women who conceive, the
incidence of spontaneous abortion (SA) has been estimated to be between 15 and 31%, and in
many cases the cause is unknown. Additionally, of the four million births yearly in the
United States, between 8 and 15% will be born prematurely and experience increased morbidity
and mortality as a result. An intervention with even a small absolute effect on any of these
outcomes has great implications at the population level due to the large potential
attributable benefit.
One such potential intervention is low-dose acetylsalicylic-acid (aspirin). Aspirin has been
a primary target of interest because of its anti-inflammatory, vasodilatory and platelet
aggregation inhibition properties. To evaluate the effects of low-dose aspirin in
combination with folic acid on the incidence of live births and spontaneous abortion, we are
conducting a multi-site randomized controlled trial study with two sites and one data
coordinating center. Women aged 18-40 currently trying to become pregnant and who have had a
single spontaneous abortion in the past year will be eligible for the study. The recruitment
goal is 1600 women. Participating women will be randomly assigned to one of two treatment
groups. Those randomized to treatment will receive daily low-dose aspirin. Those randomized
to placebo will receive daily placebo. Both groups will receive folic acid daily in
accordance with recommendations from the U.S. Public Health Service for prevention of birth
defects. The duration of treatment regimens (LDA and folic acid or placebo and folic acid)
will be 6 menstrual cycles, with those who become pregnant continuing until the end of
pregnancy. Monthly urine and blood samples will be collected and questionnaires
administered.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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