SOURCES SOUGHT
A -- The Effects of Aspirin in Gestation and Reproduction (EAGR) Trial: Clinical Sites
- Notice Date
- 11/30/2005
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, MD, 20892-7510
- ZIP Code
- 20892-7510
- Solicitation Number
- Reference-Number-NICHD-DESPR-2006-02
- Response Due
- 12/16/2005
- Archive Date
- 12/31/2005
- Description
- Background: 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 ten to 15 percent of couples attempting to conceive. Among all women who conceive, the incidence of spontaneous abortion has been estimated to be between 15 and 31 percent, and in many cases the cause is unknown. Additionally, of the four million births yearly in the United States, between eight and 15 percent 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 because of the large potential attributable benefit. Reproduction is a multi-stage process, and irregularities at any of these phases may be a sufficient cause of, or contribute to, negative outcomes. Aspirin diminishes inflammation, increases vasodilation, and inhibits platelet aggregation. It has been prescribed to subfertile or infertile women to improve outcomes at various stages of reproduction. Aspirin treatment for infertility has been shown to improve perfusion and increase endometrium thickness. In vitro fertilization (IVF) trials have suggested improved rates of implantation and pregnancies among women assigned to preconception aspirin supplementation compared with placebo. There are conflicting results among those with recurrent miscarriage. Evidence supports aspirin treatment among women with anti-phospholipids antibody syndrome. In women with idiopathic recurrent miscarriage syndrome, some studies have observed a treatment benefit while others have been inconclusive. In studies of women with normal pregnancies and women at increased risk for preeclampsia, aspirin therapy starting at 12 weeks? gestation has been shown to reduce preterm delivery, with a higher gestational age at birth among infants of those taking aspirin than placebo. The promising evidence in the IVF literature suggesting improved fecundity has been generated by studies too small to determine effects on pregnancy endpoints. Larger studies of high-risk women not using assisted reproductive technologies (ART) have begun treatment at 12 weeks? gestation at the earliest, with some starting as late as 37 weeks. It is unclear whether improved perfusion and blood flow early in pregnancy will improve pregnancy outcomes through reduction of early and late fetal losses, as well as improving fetal development. The NICHD is planning to conduct a trial to evaluate the effect of low-dose daily aspirin on reproduction at all phases beginning at preconception and continuing throughout pregnancy. The trial will assess the effects of aspirin on each of these phases, including implantation and live births. Scope: The trial will be a multi-site randomized controlled trial study design to achieve study objectives with four Clinical Sites and one Data Coordinating Center. Women aged 18 to 40 years, currently trying to become pregnant, and who have had a single spontaneous abortion in the past year will be eligible for the study. The overall for the trial recruitment goal is approximately 2000 women. Participating women will be randomly assigned to one of two groups, treatment or placebo. Those randomized to treatment will receive daily low-dose aspirin (LDA). 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 two menstrual cycles, with those who become pregnant continuing until the end of pregnancy. Study participants will be followed for the outcomes, including ovulation, determined using fertility monitors, implantation, and early pregnancy loss; clinically-recognized pregnancy, determined by presence of a fetal heartbeat from ultrasound scans; clinically-recognized spontaneous abortion; and information on stillbirth, gestational age, fetal growth, birth defects, and cesarean section. Samples collected that are not tested as part of the current protocol will be used to generate a specimen repository. The study population may be used as a cohort for future studies utilizing these samples and other information collected during the course of the study. Objective: The primary objective of the trial is to help elucidate the effects of low-dose aspirin in combination with folic acid on the incidence of live births among those women who become pregnant relative to the placebo arm. The effects of aspirin on uterine blood flow are expected to improve not only live birth rates, but also implantation, and to enhance retention of implanted trophoblasts. Accordingly, the trial has the additional goals of evaluating the effects of aspirin therapy on various outcomes. Specifically, the NICHD plans to evaluate the effect of low-dose aspirin in combination with folic acid treatment on incidence of hCG detected pregnancy, early loss of pregnancy, and on pregnancy outcomes. Due to the population prevalence of early pregnancy loss, as well as of pregnancy outcomes such as low birth weight, study findings have the potential to have great impact if even small effects are observed. To be deemed capable to serve as a Clinical Site for the trial, a small business must submit a written capability statement that clearly demonstrates the ability to: 1) recruit at least 400 women in 30 months that experienced no more or no less than one spontaneous abortion in the previous 12 months and are actively trying to get pregnant, not using contraception, and have a current male partner; 2) administrate the treatment and follow subjects for outcomes to study the effect of low-dose aspirin in combination with folic acid on the incidence of live births and other reproductive outcomes among those with hCG detected pregnancy relative to folic acid alone; 3) store, retrieve, and transport information and biological specimens; 4) create a repository of urine and serum samples for future evaluation and collect and maintain of the above mentioned records and DNA-containing samples; 5) produce, maintain, and ensure the quality of large data files. AT THIS TIME THE NICHD IS ONLY REQUESTING CAPABILITY STATEMENTS FROM SMALL BUSINESSES. THIS ANNOUNCEMENT IS NOT A REQUEST FOR PROPOSALS. The applicable North American Industry Classification System (NAICS) code for this requirement is 541710. Therefore, the small business size standard for this announcement is 500 employees or less. See http://www.sba.gov/size/ for information on what is a small business and part 121.106 of the SBA's Small Business Size Regulations on how the SBA calculates number of employees. Small Businesses that meet the applicable size standard and believe that they have the capabilities described above are encouraged to submit a written Capability Statement to attention of Charles Newman, Contracting Officer, at the address provided by 3:00 PM Local Time on December 16, 2005. The Capability Statement should be limited to no more than 15 pages and it should address each of the competencies stated above. If responses indicate a reasonable expectation of obtaining competitive offers from two or more responsible and capable small business concerns, the anticipated subsequent Request for Proposals will be set-aside or partially set-aside for small businesses.
- Record
- SN00942052-W 20051202/051130211732 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |