Vitamin D Versus Sildenafil Citrate in Fetal Growth Restriction

NCT06565728 | Completed Phase 1 DMC

• 1 other identifier: Fetal Growth Restriction
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

Fetal growth restriction, also named Intrauterine growth restriction is a prevalent disease in pregnancy , it is a descriptive term for a pathological process, and can be described as the process where a fetus who has a certain growth potential based on genetic criteria is limited in its growth because of a pathological environmental influence

Conditions

Fetal Growth Retardation

Outcome Measures

Primary Outcomes (1)

• Gestational age Measurements

  Estimation of The Gestational age at the week 28 of gestation by measuring fetal head circumference, Abdominal Circumference and fetal femur length.

  6 months

Study Arms (3)

Group A: Vitamin D3 group

ACTIVE COMPARATOR

Consists of 33 pregnant women who received oral vitamin D3 (vitamin D-3 2000 IU) and low dose aspirin.

Drug: Vitamin D3 2000 UNT Oral Tablet

Group A: Sildenafil group

ACTIVE COMPARATOR

Consists of 33 pregnant women who received oral sildenafil citrate 20 mg (Respatio) and low dose aspirin

Drug: Vitamin D3 2000 UNT Oral Tablet

Group A: Control group

ACTIVE COMPARATOR

Consists of 33 pregnant women who received low dose aspirin only

Drug: Vitamin D3 2000 UNT Oral Tablet

Interventions

Vitamin D3 2000 UNT Oral Tablet DRUG

To assess the role of vitamin D3, versus sildenafil citrate, versus control group in pregnancies complicated by fetal growth restriction

Also known as: Sildenafil Citrate, Asprin

Group A: Control group; Group A: Sildenafil group; Group A: Vitamin D3 group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with singleton spontaneous pregnancy with fetal growth restriction more than 28 weeks, confirmed by ultrasound based on estimated fetal weight and measurement of abdominal circumference (AC)\< 10th percentile for gestational age or lag of two weeks or more between the current measurements and expected one, dating since the first trimester of pregnancy.
• Age 20- 40 years.
• Patients with regular menstrual pattern before pregnancy.
• Patients are able to attend follow up as planned.

You may not qualify if:

• Patients with uncertain gestational age
• Maternal cardiovascular disease (congenital, ischemic and rheumatic heart diseases), diabetes, kidney disease, hepatic disease, anemia, antepartum hemorrhage and placenta previa.
• Patients with known or suspected foetal anomalies
• Fetal growth restriction because of severe preeclampsia.
• Use of vasodilator medication.
• Multiple pregnancies
• Smoking, drugs or alcohol abusers.
• Obstetric complications (intrauterine infection, bleeding, premature rupture of membranes).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

kasr Alainy University Hospital

Cairo, 11312, Egypt

Location

MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

Sildenafil Citrate; acetylsalicylic acid lysinate

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Omneya Mostafa Helal, Professor

  Department of Obstetrics and gynecology. Faculty of Medicine, Cairo University

  STUDY CHAIR

• Marwa Mohamed Mahmoud Eid, M.D

  Department of Obstetrics and gynecology. Faculty of Medicine, Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Obstetrics and Gynecology

Study Record Dates

• First Submitted: July 14, 2024
• First Posted: August 22, 2024
• Study Start: November 3, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 6, 2023
• Last Updated: August 22, 2024

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)