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

Primary Purpose

Small for Gestational Age at Delivery

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
omega-3 fatty acids
vaginal progesterone
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small for Gestational Age at Delivery

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Women Health Hospital - Assiut university

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Group I (omega-3 fatty acids group)

Group II (vaginal progesterone plus omega-3 group)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

The difference in mean birth weight (gram)

Secondary Outcome Measures

Estimated fetal weight (gram)
Time of delivery (weeks)
Doppler indices in the umbilical artery
Doppler indices in the uterine artery

Full Information

First Posted
November 11, 2019
Last Updated
September 18, 2022
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04161989
Brief Title
Omega 3 Plus Vaginal Progesterone on Birth Weight of Constitutionally Small for Gestational Age Fetuses
Official Title
The Effect of Omega 3 and Vaginal Progesterone on Birth Weight and Doppler Velocimetry of Constitutionally Small for Gestational Age Fetuses.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small for Gestational Age at Delivery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (omega-3 fatty acids group)
Arm Type
Other
Arm Description
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.
Arm Title
Group II (vaginal progesterone plus omega-3 group)
Arm Type
Other
Arm Description
received vaginal progesterone (Prontogest 400 mg vaginal suppository, Marcyrl Pharmaceutical Industries, Egypt) and omega 3 once daily from 28-30 weeks till delivery.
Intervention Type
Drug
Intervention Name(s)
omega-3 fatty acids
Intervention Description
. 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.
Intervention Type
Drug
Intervention Name(s)
vaginal progesterone
Intervention Description
Prontogest 400 mg vaginal suppository contains progesterone 400 mg.
Primary Outcome Measure Information:
Title
The difference in mean birth weight (gram)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Estimated fetal weight (gram)
Time Frame
6 weeks
Title
Time of delivery (weeks)
Time Frame
6 weeks
Title
Doppler indices in the umbilical artery
Time Frame
6 weeks
Title
Doppler indices in the uterine artery
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Women Health Hospital - Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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