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

Phase 4

Completed

• Conditions: Intrauterine Growth Restriction
• Interventions: Drug: Isosorbid mononitrate; Drug: Placebo

• Registration Number: NCT05800938
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2022-06-08
• Primary Completion: 2022-12-06
• Study Completion: 2022-12-06
• Study First Submitted: 2023-03-24
• Study First Submitted QC: 2023-03-24
• Status Verified: 2023-04
• Study First Posted: 2023-04-06
• Last Update Submitted: 2023-04-06
• Last Update Posted: 2023-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isosorbid mononitrate group	Isosorbid mononitrate	Imdur 30 mg tablet AstraZeneca egypt twice daily for 4 weeks
placebo group	Placebo	Tablets twice daily for 4 weeks

Primary Outcome Measures

Name	Time	Method
Reduction in umbilical artery Doppler indices	4 weeks after initiation of treatment	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

Secondary Outcome Measures

Name	Time	Method
Development of fetal complications	4 weeks after initiation of treatment	IUFD, Fetal distress or deterioration of Doppler indices requiring delivery
Enhancement of fetal growth as measured by the increase in estimated fetal weight and abdominal circumference	4 weeks after initiation of treatment	Estimation of fetal weight calculated automatic in the software of the ultrasound scanner utilizing Hadlock's formula (Biparital diameter BPD, Femur length FL, Abdominal circumference AC).
Interval to delivery	37 weeks	gestational age at delivery in weeks
Maternal side effects	4 weeks after initiation of treatment	Headache, palpitation, postural hypotension

Trial Locations

Locations (1)

Faculty of Medicine, Ain Shams University; 🇪🇬 Cairo, Egypt