Omega 3 Plus Vaginal Progesterone on Birth Weight of Constitutionally Small for Gestational Age Fetuses
Condition: Small for Gestational Age at Delivery
MeSH terms: Birth Weight
Study type: Interventional

Summary: 
      Small for gestational age refers to an infant born with a birth weight less than the 10th
      centile. Severe small for gestational age refers to an infant born with a birth weight less
      than the 3rd centile. Constitutionally small fetuses are fetuses whose growth at all
      gestational ages has been low but otherwise healthy. Those babies have a great risk for
      perinatal morbidity and mortality. Many causes are responsible for the development of Severe
      small for gestational age, however; in a few cases, the cause could not be detected. In
      contrast to pathologic intrauterine growth restriction, the constitutionally small fetuses
      have normal umbilical and middle cerebral artery Doppler velocimetry and normal amniotic
      fluid volume. In this circumstance, continued biophysical testing and delivery at 38-39 weeks
      is reasonable. Low birth weight fetuses comprise both preterm births and SGA. They are at a
      higher risk of adverse birth outcomes. So the trials to increase the blood flow to the uterus
      and/or the fetus may improve the neonatal outcomes. There are many lines of treatment that
      have been emerged now for the treatment of small for gestational age fetuses like maternal
      rest and oxygenation, aspirin therapy, supplementation of zinc, and fish oil. However; all
      mentioned lines of treatment lack evidence of effectiveness in literature. Omega-3 fatty
      acids as antioxidants inhibit the free radicals released during pregnancy which are
      responsible for vasoconstriction; so vasodilatation will occur. This leads to increase blood
      flow to the uterus and placenta which improves pregnancy outcomes. Progesterone is a smooth
      muscle relaxant and has a vasodilator effect on the blood vessels. It causes endothelium-
      relaxation of human placental arteries and veins. This relaxation is significant for
      maintaining low flow impedance and satisfactory blood flow in the placental circulation.
      DeFranco et al observed that vaginal progesterone is associated with vascular relaxation and
      increased uterine blood flow. But, he did not observe this vascular effect in women receiving
      systemic progesterone. So from the above evidence; there is a need to study the effect of
      omega 3 and progesterone on pregnant women whose pregnancy is complicated with
      constitutionally small for gestational age fetuses in trial to find a new line of treatment
      of this problem.
    


Intervention name(s): omega-3 fatty acids; vaginal progesterone
Intervention type(s): Drug; Drug
Intervention description(s): . The Omega 3 plus capsule contains 1000 mg Fish Oil (contains Eicosapentaenoic acid 13% & Docosahexaenoic acid 9%) plus 100 mg Wheat Germ Oil (Linoleic acid 52- 59%) as a natural source of Vitamin E.; Prontogest 400 mg vaginal suppository contains progesterone 400 mg.
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment