Comparing sildenafil and L-arginine for low amniotic fluid (oligohydramnios)

Efficacy of L- Arginine Versus Sildenafil in Management of Idiopathic Oligohydramnios

This will test whether sildenafil 25 mg or L-arginine 1000 mg can increase amniotic fluid and lower newborn NICU admissions in pregnant women 26–37 weeks with idiopathic oligohydramnios.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 35 Years
• Sex: Female
• Sponsor: Kafrelsheikh University (other)
• Locations: 2 sites (Kafr ash Shaykh, Kafrelsheikh and 1 other locations)
• Trial ID: NCT07135037 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional study at Kafrelsheikh University Hospital compares oral sildenafil 25 mg with oral L-arginine 1000 mg in pregnant women who have an amniotic fluid index (AFI) below 8 cm between 26 and 37 weeks. Eligible participants are under 35 years old, carry a single fetus with no major anomalies, and often have an indication for elective cesarean delivery. Primary outcomes include change in AFI and neonatal NICU admission; women with PPROM, preeclampsia, diabetes, chronic illnesses, smoking, fetal anomalies, or prior oligohydramnios treatment are excluded. The aim is to determine which medication better improves fluid levels and neonatal outcomes to inform clinician prescribing.

Who should consider this trial

Good fit: Pregnant women under 35 years old, 26–37 weeks gestation, carrying a single fetus with AFI < 8 cm, no major fetal anomalies, and often with an indication for elective cesarean are ideal candidates.

Not a fit: Women with PPROM, preeclampsia, diabetes, chronic hypertension, autoimmune or kidney disease, smokers, multiple gestation, fetal anomalies, or prior treatment for oligohydramnios are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If one drug proves superior, it could increase amniotic fluid and reduce neonatal complications, helping clinicians choose a safer, more effective treatment.

How similar studies have performed: Previous smaller studies have suggested both sildenafil and L-arginine can improve idiopathic oligohydramnios, but direct head-to-head randomized comparisons are limited.

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.

Where this trial is running

Kafr ash Shaykh, Kafrelsheikh and 1 other locations

• Kafrelsheikh University Hospital — Kafr ash Shaykh, Kafrelsheikh, Egypt (ACTIVE_NOT_RECRUITING)
• Kafrelsheokh university hospital — Kafr ash Shaykh, Kafrelsheikh, Egypt (RECRUITING)

Study contacts

• Study coordinator: Ibtesam T Gadalla, MBBch

Conditions: Oligohydramnios