Please select the eligibility criteria that correspond to the clinical trial below.
Title: Omega-3 Supplementation Decreases Inflammation and Fetal Obesity in Pregnancy
Brief Summary: Randomized, double-blind placebo controlled trial of fish oil to decrease inflammation in pregnancy.


Options:
A: Inclusion Criteria:

* 18-22 weeks pregnant (based on last menstrual period)
* 18 - 35 years old
* Resident of Cuernavaca who intends to deliver at the IMSS General Hospital I and remain in the area for the 2 years following recruitment
* Intends to predominantly breastfeed infant until 3 months of age
* Agrees to participate with informed consent

Exclusion criteria

* High risk pregnancy: If documented in the clinical record at recruitment and will include history and prevalence of abruptio placentae, any serious bleeding episode in the current pregnancy, gestational diabetes, pregnancy induced hypertension, maternal toxoplasmosis infection during pregnancy, coagulation disorders, thrombocytopenia or chronic vascular, renal or systemic disease and drug use.
* Lipid metabolism (hyperlipidemia) and/or absorption disorders
* Regular intake of fish oil or DHA supplements during pregnancy
* Chronic use of medication for illnesses like epilepsy
B: Inclusion Criteria:

* Pregnant females 16.0-35.99 years of age who are 12 to 20 weeks gestation at the time of enrollment (by dates or ultrasound)
* Agree to consume study capsules from enrollment until delivery
* BMI \<40 at baseline or weight does not exceed 300 pounds
* No serious illnesses likely to confound study outcomes
* Available by phone

Exclusion Criteria:

* Less than 16 or greater than 35.99 years of age at enrollment
* BMI \>40 at baseline
* Any serious illness likely to confound primary study outcomes
* Expecting multiple infants
* Diabetes (Type I, II or gestational) at baseline
* Elevated blood pressure due to any cause (systolic BP \>= 140 mm Hg
* Gestational age at baseline \< 12 weeks or \> 20 weeks
* Unable to provide informed consent in English
C: 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.
D: Inclusion Criteria:

* Pre-pregnant body mass index greater than 25
* Singleton pregnancy
* Speaks English

Exclusion Criteria:

* High intake of DHA foods (i.e., more than 1 fish meal per week, use of DHA-fortified foods, or use of any supplements that contain DHA)
* Concurrent inflammatory, vascular, or metabolic disease, including diabetes, polycystic ovary disease, collagen vascular disease, inflammatory bowel disease, or infection
* Current or previous use of tobacco, street drugs, or medications known to affect inflammatory markers, including corticosteroids
* Excessive weight gain or loss before pregnancy (more than 20 pounds), including weight loss due to bariatric surgery
* Plans to leave the area during the study period
* Inability to travel to General Clinical Research Center

Answer: C