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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Intrauterine Growth Restriction

Intervention / Treatment
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* Drug: Isosorbid mononitrate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Isosorbid mononitrate group<br>Imdur 30 mg tablet AstraZeneca egypt twice daily for 4 weeks | Drug: Isosorbid mononitrate<br>* Imdur tablets were given twice daily for 4 weeks<br>* Other names: Imdur;|
| Placebo Comparator: placebo group<br>Tablets twice daily for 4 weeks | Drug: Placebo<br>* Placebo tablets were given twice daily for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enhancement of fetal growth as measured by the increase in estimated fetal weight and abdominal circumference | 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). | 4 weeks after initiation of treatment | 
| Development of fetal complications | IUFD, Fetal distress or deterioration of Doppler indices requiring delivery | 4 weeks after initiation of treatment | 
| Interval to delivery | gestational age at delivery in weeks | 37 weeks | 
| Maternal side effects | Headache, palpitation, postural hypotension | 4 weeks after initiation of treatment |