Comparison Between Treatments of Oligohydramnios
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sildenafil 25 MG, L-Arginine, 1000 Mg Oral Tablet.
- Who it may be relevant to
- Registry conditions: Oligohydramnios. Basic parameters: 18 years — 35 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of L- Arginine Versus Sildenafil in Management of Idiopathic Oligohydramnios
Overview
Based on previous studies, Both sildenafil and L-arginine helped to improve idiopathic oligohydramnios. 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.
Interventions
- Drug Sildenafil 25 MG
Sildenafil is a vasodilator drug which improve blood supply to placenta.Therefore, it should improve idiopathic oligohydramnios. - Drug L-Arginine, 1000 Mg Oral Tablet
Aminoacid with vasodilator property which improve blood supply to placenta.Therefore, it should improve idiopathic oligohydramnios.
Primary outcome measures
- Improvement of amniotic fluid index [Time frame: two hours before cesarean section]
Secondary outcome measures (2)
- NICU admission [Time frame: first day after delivery]
- APGAR score [Time frame: 5 minutes after delivery]
Eligibility criteria
Inclusion criteria
- Pregnant women with gestational age between 26-37 weeks
- 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 complaining of other obstetric disorder such as, PPROM, preeclampsia, or diabetes.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 2 centers
- Kafrelsheikh University Hospital — Kafr ash Shaykh
- Kafrelsheokh university hospital — Kafr ash Shaykh
Identifiers
NCT: NCT07135037 · KFSIRB200-329