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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

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT05800938
Collaborator
(none)
46
Enrollment
1
Location
2
Arms
5.9
Actual Duration (Months)
7.7
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Isosorbid mononitrate
  • Drug: Placebo
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 8, 2022
Actual Primary Completion Date :
Dec 6, 2022
Actual Study Completion Date :
Dec 6, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Isosorbid mononitrate group

Imdur 30 mg tablet AstraZeneca egypt twice daily for 4 weeks

Drug: Isosorbid mononitrate
Imdur tablets were given twice daily for 4 weeks
Other Names:
  • Isosorbide -5- mononitrate biphasic
  • Imdur

    		•
    Placebo Comparator: placebo group

    Tablets twice daily for 4 weeks

    Drug: Placebo
    Placebo tablets were given twice daily for 4 weeks

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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).

    2. Development of fetal complications [4 weeks after initiation of treatment]

      IUFD, Fetal distress or deterioration of Doppler indices requiring delivery

    3. Interval to delivery [37 weeks]

      gestational age at delivery in weeks

    4. Maternal side effects [4 weeks after initiation of treatment]

      Headache, palpitation, postural hypotension

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine, Ain Shams University Cairo Egypt 11591

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MayaAbdElRazek, Lecturer, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT05800938
    Other Study ID Numbers:
    • FMASU MS 382/ 2022
    First Posted:
    Apr 6, 2023
    Last Update Posted:
    Apr 10, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Fetal Growth Retardation
    Isosorbide

    Study Results

    No Results Posted as of Apr 10, 2023