Intrauterine Growth Restriction
Conditions
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.
Interventions
DRUGIsosorbid mononitrate
Imdur tablets were given twice daily for 4 weeks
DRUGPlacebo
Placebo tablets were given twice daily for 4 weeks
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Development of fetal complications | 4 weeks after initiation of treatment | IUFD, Fetal distress or deterioration of Doppler indices requiring delivery |
| Interval to delivery | 37 weeks | gestational age at delivery in weeks |
| Maternal side effects | 4 weeks after initiation of treatment | Headache, palpitation, postural hypotension |
Countries
Egypt
Outcome results
None listed