Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Trial of Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in Pregnancies at High Risk
Brief Summary: A recently completed trial of weekly injections of 17 alpha hydroxyprogesterone caproate (17P) found significant effectiveness for 17P in preventing recurrent preterm birth. However, the group who received 17P in this trial still had a high rate of preterm birth. Several reports have shown that dietary supplementation of fish oil, which is rich in Omega-3 fatty acids, reduces the risk of preterm birth. This trial tests whether adding the Omega-3 supplement to 17P therapy has the potential for further reducing the risk of preterm birth in women who have previously had a spontaneous preterm delivery. The trial will compare Omega-3 fatty acid with placebo in women receiving 17P therapy. The hypothesis being tested is: "Among women at high risk for preterm birth receiving weekly injections of 17P, the addition of Omega-3 nutritional supplement will further reduce the rate of preterm birth."


Options:
A: Inclusion Criteria:

* African American race
* age between 20 and 34 years
* 16-21 weeks gestation
* household receipt of public assistance (e.g., Medicaid insurance) due to -low-income
* low levels of DHA consumption as defined as less than two fish servings per week.

Exclusion Criteria:

* known medical complications (e.g., gestational diabetes, pre-eclampsia), -regular use of steroid medications
* alcohol use
* cigarettes or use of illegal substances (by maternal report)
* use of blood thinners or anti-coagulants
* use of psychotropic medications
* Body Mass Index \>40
* allergy to iodine and/or soy.
B: Inclusion Criteria:

* BMI (wt/ht2) \> or = 25 at first antenatal visit
* Gestational age at randomization between 8-16 weeks
* No medical problems such as hyperlipidemia, hypertension, or pregestational diabetes
* Between the ages of 18 and 40 years old
* Non-smokers
* No obstetrical problems such as a history of preeclampsia or gestational diabetes
* Confirmed singleton pregnancy

Exclusion Criteria:

* Major fetal anomaly
* Regular intake of fish oil supplements (defined as greater than 500 mg per week within the last four weeks). This is due to the placebo group receiving fish oil outside of the study.
* Daily use of nonsteroidal anti-inflammatory agents
* Allergy to fish or fish products, gluten intolerant (because the placebo contains wheat germ oil, which is not gluten free).
* Women who are vegetarians and do not eat any fish.
* Infants born preterm (less than 36 weeks gestation) or less than 2kg.
* Heparin use or known thrombophilia (thrombophilias include homozygous for Factor V Leiden).
* Moderate or high titer IgG anticardiolipin antibodies or prolonged activated PTT or other indication of presence of lupus anticoagulant, homozygous for prothrombin gene (G20210A) mutation, antithrombin III deficiency.
* Protein S (low levels outside of pregnancy) or Protein C deficiency.
* Hyperhomocysteinemia (due to safety concerns because n-3 may affect bleeding time).
* Hemophiliacs including von Willebrand's disease (because of safety concerns associated with the hemophilia treatment combined with the n-3 supplements).
* Planned termination of pregnancy.
* Current hypertension or current use of antihypertensive medication (including diuretics), due to increased risk of adverse pregnancy outcome.
* Pregestational diabetes due to increased risks of affecting fetal growth. We will not exclude women who develop GDM during pregnancy but consider a sub-analyses of these women depending on the number of subjects. Known maternal medical complications: cancer (including melanoma but excluding other skin cancers).
* Current hyperthyroidism if not adequately controlled.
* Renal disease with altered renal function (serum creatinine \> 1.5).
* Epilepsy or other seizure disorder.
* Systemic lupus (not discoid lupus), scleroderma, polymyalgia rheumatic.
* Active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes).
* Platelet or red blood cell disorder (including idiopathic thrombocytopenia purpura, a history of alloimmune thrombocytopenia in a previous offspring, significant anemia due to hemoglobinopathy but not sickle cell trait. Iron deficiency anemia will NOT be an exclusion as long as the hemoglobin is \> 8 gm/dl).
* Chronic pulmonary disease (asthma of any degree of severity is NOT an exclusion).
* Structural, functional or ischemic heart disease. Neither mitral valve prolapse nor paroxysmal supraventricular tachycardia are considered exclusions.
* Known HIV positive with viral load greater than 1,000 copies/ml or CD4 count less than 350/mm3.
* Current or planned cerclage due to interference with the natural cause of delivery.
* Illicit drug or alcohol abuse during current pregnancy.
* At the time of birth, all infants will be evaluated by a pediatrician to make sure that they are healthy. Infants will be excluded from further study if they have any medical problems such as respiratory distress syndrome.
* Infants will also be excluded if they have any problems that exclude them from having estimation of body composition, for e.g. birth weight less than 2 kg.
C: Inclusion Criteria:

* Documented history of previous singleton spontaneous birth
* Singleton pregnancy
* Gestational age at randomization between 16 and 22 weeks

Exclusion Criteria:

* Major fetal anomaly or demise
* Regular intake of fish oil supplements
* Daily use of nonsteroidal anti-inflammatory agents
* Allergy to fish or fish products
* Gluten intolerant
* Heparin use or known thrombophilia
* Hemophilia
* Planned termination
* Current hypertension or current use of antihypertensive medications
* Type D, F or R diabetes
* Maternal medical complications
* Current or planned cerclage
* Illicit drug or alcohol abuse during current pregnancy
* Delivery at a non-Network hospital
* Participation in another pregnancy intervention study
* Participation in this trial in a previous pregnancy
D: Inclusion Criteria:

* 12-16 weeks gestation
* Low risk pregnancy
* Expected to deliver single full term
* No maternal metabolic or infectious disease
* No known fetal complications.

Answer: C