Omega 3 Plus Vaginal Progesterone on Birth Weight of Intrauterine Growth-restricted Fetuses

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Intrauterine growth restriction defines as the failure of the fetus to get its normal growth and specific measures threshold along a normal centile. Intrauterine growth restriction is a serious obstetric problem that affects about 10-15% of pregnant women. Those intrauterine growth restriction babies have a great risk for perinatal morbidity and mortality. Many causes are responsible for the development of asymmetrically intrauterine growth restriction, however; in a few cases, the cause could not be detected so it is called idiopathic intrauterine growth restriction. They are great controversies regarding the treatment of idiopathic asymmetrically intrauterine growth restriction. The termination of pregnancy may be preferable in some cases; however, the trials to improve blood flow to the uterus and/or the fetus may be also beneficial.

Omega-3 fatty acids as antioxidants inhibit the release of the free radicals during pregnancy so vasodilatation will occur. This leads to increase blood flow to the uterus and placenta resulting in increasing amniotic fluid volume in cases of unexplained oligohydramnios and improving pregnancy outcomes in intrauterine growth restriction fetuses.

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 the vaginal progesterone is associated with vascular relaxation and increased uterine blood flow. In addition, he did not observe this vascular effect in women receiving systemic progesterone.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assiut University
• Treatments: Progesterone

Criteria

Inclusion Criteria:

1. Gestational age between 28- 30 weeks.

2. Singleton pregnancy with idiopathic asymmetrical intrauterine growth restriction.

Exclusion Criteria:

1. Multiple gestations.

2. Women with chronic diseases like hypertensive, diabetes mellitus, antiphospholipid syndrome, systemic lupus erythematosus, renal diseases, cardiac diseases, blood diseases ...etc.

3. Premature rupture of membranes.

4. Congenital fetal malformation.

5. Pregnancy was complicated by antepartum hemorrhage.

6. Low amniotic fluid volume at the time of recruitment (< 5cm).

7. Women who known to have an allergy to vaginal progesterone.