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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
Patients meeting these criteria are to be randomized into one of the following 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isosorbid mononitrate group | Active Comparator | Imdur 30 mg tablet AstraZeneca egypt twice daily for 4 weeks |
|
| placebo group | Placebo Comparator | Tablets twice daily for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isosorbid mononitrate | Drug | Imdur tablets were given twice daily for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 weeks after initiation of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 4 weeks after initiation of treatment |
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Inclusion Criteria:
Exclusion Criteria:
Had known or suspected chromosomal or structural anomaly Had a condition which will require delivery Multiple pregnancy
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Ain Shams University | Cairo | 11591 | Egypt |
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| Placebo | Drug | Placebo tablets were given twice daily for 4 weeks |
|
| Development of fetal complications |
IUFD, Fetal distress or deterioration of Doppler indices requiring delivery |
| 4 weeks after initiation of treatment |
| Interval to delivery | gestational age at delivery in weeks | 37 weeks |
| Maternal side effects | Headache, palpitation, postural hypotension | 4 weeks after initiation of treatment |
| ID | Term |
|---|---|
| D005317 | Fetal Growth Retardation |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C030397 | isosorbide-5-mononitrate |
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