NCT05800938

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Isosorbid mononitrate	Imdur tablets were given twice daily for 4 weeks
DRUG	Placebo	Placebo tablets were given twice daily for 4 weeks

Timeline

• Start date: 2022-06-08
• Primary completion: 2022-12-06
• Completion: 2022-12-06
• First posted: 2023-04-06
• Last updated: 2023-04-10

Locations

1 site across 1 country: Egypt