Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2024-09-01
2025-12-31
Brief Summary
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In this study, Level of improvment of oligohydramnios will be compared. As well as, NICU admission to neonates of pregnancies complicated by idiopathic oligohydramnios. The end goal is to help physicians use the best drug for their patients.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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sildn arm
In this group, participants receive sildenafil 25 mg thrice a day. then amniotic fluid index is measured every week to measure its improvement. After delivery, APGAR will be measured. As well as, whether the fetus entered the NICU or not will be recorded.
Sildenafil 25 MG
Sildenafil is a vasodilator drug which improve blood supply to placenta.Therefore, it should improve idiopathic oligohydramnios.
L- argin arm
In this group, participants receive L- arginine 1000 mg thrice a day. then amniotic fluid index is measured every week to measure its improvement. After delivery, APGAR will be measured. As well as, whether the fetus entered the NICU or not will be recorded.
L-Arginine, 1000 Mg Oral Tablet
Aminoacid with vasodilator property which improve blood supply to placenta.Therefore, it should improve idiopathic oligohydramnios.
Interventions
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Sildenafil 25 MG
Sildenafil is a vasodilator drug which improve blood supply to placenta.Therefore, it should improve idiopathic oligohydramnios.
L-Arginine, 1000 Mg Oral Tablet
Aminoacid with vasodilator property which improve blood supply to placenta.Therefore, it should improve idiopathic oligohydramnios.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pregnant women whose age is \< 35 years
* Woman with other indication for elective caesarean section.
* Women carrying a single fetus with no major anomalies.
* Initial amniotic fluid index \<8cm determined by reliable pelivabdominal ultrasound.
Exclusion Criteria
* Women with chronic illness such as, chronic hypertension, autoimmune disease or kidney disease.
* Women who received other treatments for oligohydramnios in current pregnancy.
* Women who smoke.
* Fetuses with major congenital anomaly.
18 Years
35 Years
FEMALE
Yes
Sponsors
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Kafrelsheikh University
OTHER
Responsible Party
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Ibtesam Teleb Mohamed Yousef Gadalla
principle investigator
Principal Investigators
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Locations
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Kafrelsheikh University Hospital
Kafr ash Shaykh, Kafrelsheikh, Egypt
Kafrelsheokh university hospital
Kafr ash Shaykh, Kafrelsheikh, Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KFSIRB200-329
Identifier Type: -
Identifier Source: org_study_id
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