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

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Intrauterine Growth Restriction

Treatments: Drug: Placebo; Drug: Isosorbid mononitrate

Study type: Interventional

Funder types: Other

Identifiers

NCT05800938

FMASU MS 382/ 2022

Details and patient eligibility

About

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

Full 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.

Enrollment: 46 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups, including a placebo group

Isosorbid mononitrate group

Active Comparator group

Description:

Imdur 30 mg tablet AstraZeneca egypt twice daily for 4 weeks

Treatment:

Drug: Isosorbid mononitrate

placebo group

Placebo Comparator group

Description:

Tablets twice daily for 4 weeks

Treatment:

Drug: Placebo