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

The Effect of Omega 3 and Vaginal Progesterone on Birth Weight and Doppler Velocimetry of Constitutionally Small for Gestational Age Fetuses.

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.

Study Overview

• Status: Completed
• Conditions: Small for Gestational Age at Delivery
• Intervention / Treatment: Drug: omega-3 fatty acids; Drug: vaginal progesterone

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Women Health Hospital - Assiut university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group I (omega-3 fatty acids group); 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; . 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.
Other: Group II (vaginal progesterone plus omega-3 group); 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; . 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.; Drug: vaginal progesterone; Prontogest 400 mg vaginal suppository contains progesterone 400 mg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The difference in mean birth weight (gram)	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: November 11, 2019
• First Submitted That Met QC Criteria: November 11, 2019
• First Posted (Actual): November 13, 2019

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 18, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Birth Weight; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone
• Other Study ID Numbers: SGA-VP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No