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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

Primary Purpose

Intrauterine Growth Restriction

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Isosorbid mononitrate
Placebo
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intrauterine Growth Restriction

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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 -

Sites / Locations

  • Faculty of Medicine, Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Isosorbid mononitrate group

placebo group

Arm Description

Imdur 30 mg tablet AstraZeneca egypt twice daily for 4 weeks

Tablets twice daily for 4 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
Development of fetal complications
IUFD, Fetal distress or deterioration of Doppler indices requiring delivery
Interval to delivery
gestational age at delivery in weeks
Maternal side effects
Headache, palpitation, postural hypotension

Full Information

First Posted
March 24, 2023
Last Updated
April 6, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05800938
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 8, 2022 (Actual)
Primary Completion Date
December 6, 2022 (Actual)
Study Completion Date
December 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

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

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrauterine Growth Restriction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Isosorbid mononitrate group
Arm Type
Active Comparator
Arm Description
Imdur 30 mg tablet AstraZeneca egypt twice daily for 4 weeks
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
Tablets twice daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Isosorbid mononitrate
Other Intervention Name(s)
Isosorbide -5- mononitrate biphasic, Imdur
Intervention Description
Imdur tablets were given twice daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets were given twice daily for 4 weeks
Primary Outcome Measure Information:
Title
Reduction in umbilical artery Doppler indices
Description
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
Time Frame
4 weeks after initiation of treatment
Secondary Outcome Measure Information:
Title
Enhancement of fetal growth as measured by the increase in estimated fetal weight and abdominal circumference
Description
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).
Time Frame
4 weeks after initiation of treatment
Title
Development of fetal complications
Description
IUFD, Fetal distress or deterioration of Doppler indices requiring delivery
Time Frame
4 weeks after initiation of treatment
Title
Interval to delivery
Description
gestational age at delivery in weeks
Time Frame
37 weeks
Title
Maternal side effects
Description
Headache, palpitation, postural hypotension
Time Frame
4 weeks after initiation of treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 -
Facility Information:
Facility Name
Faculty of Medicine, Ain Shams University
City
Cairo
ZIP/Postal Code
11591
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

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

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