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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05800938
Other study ID # FMASU MS 382/ 2022
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 8, 2022
Est. completion date December 6, 2022

Study information

Verified date April 2023
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date December 6, 2022
Est. primary completion date December 6, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility 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


Intervention

Drug:
Isosorbid mononitrate
Imdur tablets were given twice daily for 4 weeks
Placebo
Placebo tablets were given twice daily for 4 weeks

Locations

Country Name City State
Egypt Faculty of Medicine, Ain Shams University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Development of fetal complications IUFD, Fetal distress or deterioration of Doppler indices requiring delivery 4 weeks after initiation of treatment
Secondary Interval to delivery gestational age at delivery in weeks 37 weeks
Secondary Maternal side effects Headache, palpitation, postural hypotension 4 weeks after initiation of treatment
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