NCT04161989

Omega 3 Plus Vaginal Progesterone on Birth Weight of Constitutionally Small for Gestational Age Fetuses

Completed NA Last updated 21 September 2022

What this trial tests

NA trial testing omega-3 fatty acids in Small for Gestational Age at Delivery in 80 participants. Completed in 1 June 2022.

Timeline

1 May 2020

Primary endpoint
1 June 2022

1 June 2022

Quick facts

Lead sponsor	Assiut University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	80
Start date	1 May 2020
Primary completion	1 June 2022
Estimated completion	1 June 2022
Sites	1 location across Egypt

Drugs / interventions tested

• omega-3 fatty acids — full drug profile →
• vaginal progesterone — full drug profile →

Conditions studied

• Small for Gestational Age at Delivery — all drugs for Small for Gestational Age at Delivery →

Sponsor

Assiut University

Who can join

Adults 20 to 35, female only, with Small for Gestational Age at Delivery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.