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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,228
81mg of low-dose aspirin plus 400micrograms of folic acid.
400micrograms of folic acid.
University of Colorado, Denver School of Medicine, Department of Obstetrics and Gynecology
Denver, Colorado, United States
Women's Health Research Center, Department of Social and Preventive Medicine, University at Buffalo
Buffalo, New York, United States
Moses Taylor Hospital
Scranton, Pennsylvania, United States
University of Utah Medical Center
Salt Lake City, Utah, United States
Live Birth
Live birth was obtained prospectively by maternal report and abstraction from medical records by trained staff .
Time frame: after delivery
hCG Recognized Pregnancy
Time frame: within 8-weeks of gestation
Clinically Recognized Pregnancy
Time frame: 8-weeks
Early Pregnancy Loss (EPL)
Implantation failures
Time frame: 8 weeks
Pregnancy Losses Occurring Less Than 10 Weeks
Includes preembryonic and embryonic losses (exclusive of implantation failures)
Time frame: less than 10-weeks
Fetal Pregnancy Loss
Time frame: until 40 weeks
Stillbirth
Time frame: 40 weeks
Ectopic Pregnancy
Time frame: within 6 weeks
Molar Pregnancy
Time frame: 8 weeks
Preeclampsia
Time frame: until delivery
Small for Gestational Age Infant
birthweight
Time frame: until delivery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Preterm Birth
Time frame: until delivery
Abnormal Fetal Testing
Time frame: 8 weeks
Fetal Intolerance of Labor
Time frame: until delivery
Abruption
Partial or complete abruption (ie, premature separation of the placenta)
Time frame: until delivery