Clinical trial: The Effects of Aspirin in Gestation and Reproduction (NCT00467363)

Eligibility criteria:
Inclusion Criteria:

          -  Women experiencing one or two pregnancy losses at any point in gestation in the past
             that were not elective termination(s). At least one of these losses must be well
             documented by one of the following:

               -  Sonogram demonstrating anembryonic loss, embryonic loss or fetal death.

               -  Histologic confirmation of products of conception that were spontaneously passed
                  per vagina or surgically obtained.

               -  Hospital records of fetus delivery.

               -  Late menses and positive serum hCG or positive urine hCG documented by hospital
                  or clinic records followed by either a negative hospital/clinic pregnancy test or
                  a decline in urinary hCG level over 3 days.

               -  Home pregnancy tests without hCG confirmation from a healthcare provider (either
                  serum or urine) will not be accepted.

          -  No more than 5 pregnancies in total including the pregnancy loss(es).*

          -  Up to two prior pregnancies that did not end in a loss.*

             *Women may have up to two pregnancies beyond 20 weeks that were not losses, two
             spontaneous pregnancy losses at any time in the past, and up to one therapeutic or
             elective termination (two therapeutic or elective terminations if no other
             pregnancies). Ectopic and molar pregnancies would, for the purpose of enrollment, be
             considered in the same category as therapeutic termination pregnancies. Women with
             more than two live births or those with more than two losses, regardless of the week
             of gestation of the loss, are excluded.

          -  Presence of intact tubes (both), ovaries (both), and uterus.

          -  Between 18 and 40 years of age at time of baseline visit.

          -  Regular menstrual periods between 21 - 42 days in length (within the last 12 months).
             Regular menstrual periods are defined as no more than an 8-day difference between the
             woman's shortest and longest cycle.

          -  No more than one missed menses in the past 12 months (other than those missed due to
             pregnancy or breastfeeding).

          -  Actively trying to conceive with a male partner and not using contraception by the
             baseline visit.

          -  Not currently pregnant at the baseline or randomization visits.

          -  Ability and willingness to give informed consent.

          -  Willingness to be randomized and to take daily study pills for 6 months to a possible
             15 months

        Exclusions Criteria:

          -  Known allergies to aspirin or non-steroidal anti-inflammatory agents.

          -  Clinical indication for anticoagulant therapy. These include prior or current
             thrombosis, antiphospholipid syndrome (APS) or known major thrombophilia.

          -  Clinical indication for chronic use of NSAIDs such as rheumatoid arthritis.

          -  Indication for additional folic acid supplementation, such as prior infant with neural
             tube defect (NTD), seizure disorder.

          -  Medical contraindication to aspirin therapy. These include uncontrolled asthma, nasal
             polyps, bleeding disorders, or history of gastrointestinal ulcer.

          -  Presence of major medical disorders (regardless of severity). These include diabetes,
             hypertension, systemic lupus erythematosus (SLE), untreated or active cancer (any
             cancer in remission or non-melanoma skin cancer is not included in the exclusion
             criteria), liver disease, renal disease, rheumatoid arthritis, cardiac disease,
             pulmonary disease other than mild asthma, neurologic disease requiring medical
             treatment, uncontrolled hypothyroidism, uncontrolled seizure disorder. Untreated
             vitamin B12 deficiency, severe anemia (Hct < 30%), hemophilia, gout, nasal polyps,
             among others.

          -  Currently undergoing/planned use of assisted reproductive techniques during trial
             (IVF; IUI; Clomid).

          -  History of infertility or sub-fertility. This includes any of the following:

               -  No conception after ≥ 1 year of unprotected intercourse and actively trying to
                  conceive.

               -  Any prior medical treatment for infertility.

               -  Prior treatment for known pelvic inflammatory disease.

               -  Known male infertility or sperm abnormality (current partner).

               -  Known tubal occlusion, anovulation, uterine abnormality, or endometriosis stage
                  III or IV.

               -  History of polycystic ovarian syndrome.

          -  Presence of unstable mental disorder. These include bipolar illness, schizophrenia,
             uncontrolled depression, uncontrolled anxiety disorder.

          -  Known current or recent alcohol abuse or illicit drug use.

          -  Current diagnosis of sexually transmitted infection (STI) (temporary exclusion)
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years

Patient description (medical language): A 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? Entailment