Actively Recruiting
Efficacy of L-Arginine Versus Sildenafil in Management of Idiopathic Oligohydramnios
Led by Kafrelsheikh University · Updated on 2025-08-21
40
Participants Needed
2
Research Sites
15 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of two drugs, sildenafil and L-arginine, on idiopathic oligohydramnios, a condition characterized by low amniotic fluid during pregnancy. The study aims to compare the improvement level of the amniotic fluid index and the rate of neonatal intensive care unit (NICU) admissions for newborns whose mothers have this condition. This Phase 2 trial is sponsored by Kafrelsheikh University and focuses on pregnant women aged 18 to 35 years. Participants are randomly assigned to receive either sildenafil 25 mg three times a day or L-arginine 1000 mg three times a day. The amniotic fluid index will be measured weekly to track improvement. After delivery, the newborn's APGAR score will be recorded five minutes after birth, and NICU admissions will be monitored the first day after delivery. The study uses a single-blind design where participants are unaware of which treatment they receive. During the study, participants will have weekly ultrasound assessments to measure amniotic fluid levels. Researchers will collect data on the newborn's condition immediately after birth through APGAR scoring and NICU admission records. The primary outcome is the improvement of the amniotic fluid index measured two hours before cesarean section. The study is expected to last until the end of 2025, with ongoing monitoring of safety and treatment effects during the pregnancy and delivery period.
CONDITIONS
Brief Title
Comparison Between Treatments of Oligohydramnios
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women with gestational age between 26 and 37 weeks
- Women younger than 35 years
- Women scheduled for elective cesarean section
- Women carrying a single fetus with no major anomalies
- Initial amniotic fluid index less than 8 cm confirmed by reliable ultrasound
You will not qualify if you...
- Women with obstetric disorders such as premature rupture of membranes, preeclampsia, or diabetes
- Women with chronic illnesses including chronic hypertension, autoimmune diseases, or kidney disease
- Women who received other treatments for oligohydramnios during the current pregnancy
- Women who smoke
- Fetuses with major congenital anomalies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until delivery between 26 and 37 weeks of gestation
Participants receive either sildenafil 25 mg or L-arginine 1000 mg three times a day to improve amniotic fluid levels.
Weekly visits to measure amniotic fluid index
Duration - Immediately after delivery
After delivery, participants’ newborns are assessed for APGAR score and NICU admission.
1 visit (in-person) after delivery
Trial Site Locations
Total: 2 locations
1
Kafrelsheikh University Hospital
Kafr ash Shaykh, Kafrelsheikh, Egypt, 33513
Active, Not Recruiting
2
Kafrelsheokh university hospital
Kafr ash Shaykh, Kafrelsheikh, Egypt, 33513
Actively Recruiting
Research Team
I
Ibtesam T Gadalla, MBBch
M
Mostafa F El-lakany, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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