الفهرس 
INTRAUTERINE GROWTH RESTRICTION ”DEFINITION, TYPES AND DIAGNOSIS”Only 14 pages are availabe for public view
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Abstract
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ntrauterine growth restriction (IUGR) is associated with impaired placentation (Gurugubelli Krishna and Vishnu Bhat, 2018)
Patients who are at risk of developing IUGR can be identified by abnormal umbilical artery Doppler at mid-trimester pregnancy (Colson et al., 2021)
Nitric oxide (NO)-donors like isosorbide mononitrate reduce the impedance in the uteroplacental vessels and possess protecting effects on the endothelium (Ponmozhi et al., 2019)
Consequently, this study was conducted and aimed to evaluate the efficacy and tolerability of Isosorbide Mononitrate therapy in reducing umbilical artery Doppler resistance index (RI) in pregnancies with fetal growth restriction.
This prospective randomized control trial was conducted at Obstetric Outpatient Clinic – Obstetrics and Gynecology Department, Faculty of Medicine, Ain Shams University Maternity Hospitals from February 2022 until February 2023 and performed on women who attended ASUMH ECDU with IUGR.
During this study, 58 patients were assessed for eligibility and 46 patients were included in the study. Of all eligible patients, 8 patients were excluded from the study based on the inclusion criteria and 4 patients refused to participate in of the study. Patients were randomized into one of the following two groups; group A who received (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) and group B who received (Osteocare®, tab, VITABIOTICS, Egypt) twice daily for 4-6 weeks. Primary outcome of our study was reduction in umbilical artery Doppler Resistance Index (RI). Secondary outcomes were enhancement of fetal growth as measured by the increase in estimated fetal weight (EFW) and abdominal circumference (AC), in percentiles, development of fetal complications: IUFD, fetal distress and deterioration of Doppler indices requiring delivery, interval to delivery and maternal side effects caused by the medication such as headache, palpitations and postural hypotension.
To the best of our knowledge, there is a paucity of studies in literature assessing the efficacy and tolerability of Isosorbide Mononitrate therapy in reducing umbilical artery Doppler resistance index (RI) in pregnancies with fetal growth restriction.
As regard baseline characteristics, our study revealed that there were no statistically significant differences between study groups as regard maternal age, BMI, gestational age and special habits and associated maternal diseases.
As regard obstetric history, our study noted that there were no statistically significant differences between study groups as regard gravidity, parity, previous abortions, stillbirths and SGA fetuses.
The current study shows that there is statistically significant improvement in isosorbide mononitrate group in mean umbilical artery Doppler resistance index 0.81±0.02SD Vs 0.75±0.05, before and after treatment respectively (P<0.001), while in placebo group demonstrated improvement but not statistically significant in mean umbilical artery Doppler resistance index 0.79±0.03SD Vs 0.77±0.04SD, before and after treatment respectively. By comparing the two groups after treatment, the improvement in umbilical artery Doppler resistant index was statistically non-significant (P= 0.181).
In group A, the mean of estimated fetal weight is 1113.22 before treatment and is 1419.78 after treatment, showing an increase in weight by 27.538 %. On the other hand, in group B, the mean of estimated fetal weight is 1163.48 before placebo and is 1339.78 showing an increase in weight of 15.152 %. In spite of the increase in estimated fetal weight more with isosorbide mononitrate compared to calcium, this increase was suboptimal compared with growth curve at this gestational age and this increase doesn’t reach significant value.
There was a statistically significant enhancement in AC measurement in Isosorbide mononitrate 212.48 mm ±11.06SD Vs 248.43 mm ±17.03SD, before and after treatment respectively (P<0.001). In placebo group also there is enhancement 212.48±11.06 vs 248.43±17.03 before and after treatment. By comparing two groups regarding AC there was a statistically significant enhancement in AC measurement in Isosorbide mononitrate group compared to the placebo group
Also, there were no statistically significant differences between study groups as regard IUFD, fetal distress, deterioration of Doppler indices requiring delivery and Interval to delivery with p= 0.130, 0.32, 0.073, 0.060 respectively.
Finally, as regard side effects of isosorbide mononitrate therapy, the current study reported that headache and overall side effects were statistically significant higher compared with control group.
As evidence in the current study NO-donor has no role in management of FGR with mild Doppler changes and associated with maternal side effects.
It had mild improving effect on umbilical artery Doppler or placental circulation.
NO-donor like isosorbide mononitrate is not recommended as an option in management of pregnant women with FGR with mild doppler changes, so not worthy to recommend it for these cases. Severe Doppler changes cases need to be investigated in more studies with larger sample size.