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Completed

NCT Number: NCT05800938

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

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

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Key information

Conditions

Intrauterine Growth Restriction Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Growth Retardation Growth Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine, Ain Shams University

Cairo, 11591, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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Treatment and study plan

Isosorbid mononitrate

Drug

Imdur tablets were given twice daily for 4 weeks

Other names: Isosorbide -5- mononitrate biphasic, Imdur

Placebo

Drug

Placebo tablets were given twice daily for 4 weeks

Primary outcomes

  1. Reduction in umbilical artery Doppler indices

    Time frame: 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 outcomes

  1. Enhancement of fetal growth as measured by the increase in estimated fetal weight and abdominal circumference

    Time frame: 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

    Time frame: 4 weeks after initiation of treatment

    IUFD, Fetal distress or deterioration of Doppler indices requiring delivery

  3. Interval to delivery

    Time frame: 37 weeks

    gestational age at delivery in weeks

  4. Maternal side effects

    Time frame: 4 weeks after initiation of treatment

    Headache, palpitation, postural hypotension

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 6, 2023
Registry last updated
Apr 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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