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

NCT04161989 | Completed

• 1 other identifier: SGA-VP
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Small for Gestational Age at Delivery

Outcome Measures

Primary Outcomes (1)

• The difference in mean birth weight (gram)

  6 weeks

Secondary Outcomes (4)

• Estimated fetal weight (gram)

  6 weeks

• Time of delivery (weeks)

  6 weeks

• Doppler indices in the umbilical artery

  6 weeks

• Doppler indices in the uterine artery

  6 weeks

Study Arms (2)

Group I (omega-3 fatty acids group)

OTHER

received omega 3 (Omega 3 plus, SEDICO, Egypt); once daily from 28-30 weeks till delivery. The omega 3 plus capsule contains 1000 mg Fish Oil plus 100 mg Wheat Germ Oil is a natural source of Vitamin E.

Drug: omega-3 fatty acids

Group II (vaginal progesterone plus omega-3 group)

OTHER

received vaginal progesterone (Prontogest 400 mg vaginal suppository, Marcyrl Pharmaceutical Industries, Egypt) and omega 3 once daily from 28-30 weeks till delivery.

Drug: omega-3 fatty acids; Drug: vaginal progesterone

Interventions

omega-3 fatty acids DRUG

. 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.

Group I (omega-3 fatty acids group); Group II (vaginal progesterone plus omega-3 group)

vaginal progesterone DRUG

Prontogest 400 mg vaginal suppository contains progesterone 400 mg.

Group II (vaginal progesterone plus omega-3 group)

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women aged 20-35 years.
• Pregnant women from 28 to 30 weeks gestation.
• Women with small for gestational age fetus. It refers to an estimated fetal weight or abdominal circumference \<10th centile with no pathology is present.
• Women with normal resistant index in uterine arteries at the time of recruitment.
• Women with normal resistant index in umbilical arteries at the time of recruitment.

You may not qualify if:

• Women with estimated fetal weight below the 5th or 3rd percentile.
• Women with any major risk factors for intrauterine growth restriction.
• Women with multiple pregnancies.
• Women with low amniotic fluid volume or premature pre-labor rupture of membranes.
• Women with antepartum hemorrhage or fetal congenital anomalies.
• Women with absent or reversed diastolic flow in the umbilical artery at the time of recruitment.
• Women with any contraindications for progesterone or omega 3.
• Women who refused to participate in our study.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Interventions

Fatty Acids, Omega-3

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 13, 2019
• Study Start: May 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Locations

EG (1)