Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05800938
Status:
COMPLETED
Last Update Posted:
2023-04-10
First Post:
2023-03-24
Brief Title:
The Effect of Oral Isosorbide Mononitrate Therapy on Umbilical Artery Doppler Resistance Index in Pregnancies With Intrauterine Growth Restriction Prospective Randomized Control Trial
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
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
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n23 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 n23 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 005 and according to Trapani et al 2015 the expected change in UTA-PI in isosorbide mononitrate group21 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
Group A n23 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 n23 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 005 and according to Trapani et al 2015 the expected change in UTA-PI in isosorbide mononitrate group21 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None