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

NCT ID: NCT05800938

Last Updated: 2023-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-08
• Study Completion Date: 2022-12-06

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

Detailed Description

Patients meeting these criteria are to be randomized into one of the following two groups:

• Group A (n=23): The Isosorbide Mononitrate group: will receive (IMDUR®, 30 mg, tablet, AstraZeneca, Egypt) (Isosorbide-5-mononitrate Biphasic) twice daily for 4-6 weeks (according to xPharm: The Comprehensive Pharmacology Reference, 2007, Pages 1-4).
• Group B (n=23): The placebo group will receive (Osteocare®, tab, VITABIOTICS, Egypt) twice daily for 4-6 weeks Justification: Using PASS 11 program for sample size calculation, setting power at 80% and alpha error at 0.05 and according to "Trapani et al., 2015", the expected change in UTA-PI in isosorbide mononitrate group=21% compared to no change in placebo group. Sample size of 23 women per group will be needed to detect difference between two groups.

The study is to be double-blinded, where neither the researcher, nor the participants will know what type of medication each participant will receive, as a nurse will give each patient a closed envelope containing 21 tablets of one of the above two medications in a randomized fashion.

Conditions

Intrauterine Growth Restriction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Isosorbid mononitrate group

Imdur 30 mg tablet AstraZeneca egypt twice daily for 4 weeks

Group Type: ACTIVE_COMPARATOR

Isosorbid mononitrate

Intervention Type: DRUG

Imdur tablets were given twice daily for 4 weeks

placebo group

Tablets twice daily for 4 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablets were given twice daily for 4 weeks

Interventions

Isosorbid mononitrate

Imdur tablets were given twice daily for 4 weeks

Intervention Type: DRUG

Placebo

Placebo tablets were given twice daily for 4 weeks

Intervention Type: DRUG

Other Intervention Names

Isosorbide -5- mononitrate biphasic; Imdur

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

MayaAbdElRazek

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine, Ain Shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FMASU MS 382/ 2022

Identifier Type: -

Identifier Source: org_study_id