The Effect of Oral Isosorbide Mononitrate Therapy on Umbilical Artery Doppler Resistance Index in Pregnancies With Intrauterine Growth Restriction: Prospective Randomized Control Trial

NCT05800938 | Completed Phase 4

• 1 other identifier: FMASU MS 382/ 2022
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Will follow up umblical artery Doppler indices for pregnancies with iugr taking placebo and oral isosorbide mononitrate to study its efficacy on the intrauterine growth restricted fetuses

Conditions

Intrauterine Growth Restriction

Outcome Measures

Primary Outcomes (1)

• Reduction in umbilical artery Doppler indices

  Measuring of the umbilical artery Doppler resistant index (RI) with the patient in semi recombinant position, during a period of absent fetal movement and breathing. a minimum of three uniform Doppler waveforms will be measured

  4 weeks after initiation of treatment

Secondary Outcomes (4)

• Enhancement of fetal growth as measured by the increase in estimated fetal weight and abdominal circumference

  4 weeks after initiation of treatment

• Development of fetal complications

  4 weeks after initiation of treatment

• Interval to delivery

  37 weeks

• Maternal side effects

  4 weeks after initiation of treatment

Study Arms (2)

Isosorbid mononitrate group

ACTIVE COMPARATOR

Imdur 30 mg tablet AstraZeneca egypt twice daily for 4 weeks

Drug: Isosorbid mononitrate

placebo group

PLACEBO COMPARATOR

Tablets twice daily for 4 weeks

Drug: Placebo

Interventions

Isosorbid mononitrate DRUG

Imdur tablets were given twice daily for 4 weeks

Also known as: Isosorbide -5- mononitrate biphasic, Imdur

Isosorbid mononitrate group

Placebo DRUG

Placebo tablets were given twice daily for 4 weeks

placebo group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age : 18-34 BMI: 18-30 Singleton pregnancy Gestational age between 28-30 Criteria of IUGR

You may not qualify if:

• Had known or suspected chromosomal or structural anomaly Had a condition which will require delivery Multiple pregnancy

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine, Ain Shams University

Cairo, 11591, Egypt

Location

MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

isosorbide-5-mononitrate

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 6, 2023
• Study Start: June 8, 2022
• Primary Completion: December 6, 2022
• Study Completion: December 6, 2022
• Last Updated: April 10, 2023

Record last verified: 2023-04

Locations

EG (1)