Comparison Between Treatments of Oligohydramnios

NCT07135037 — Phase 2, Unknown, 40 participants, Kafrelsheikh University

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

Registry	NCT07135037
Status	Unknown
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	40 (Estimated)
Sponsor	Kafrelsheikh University (Other)
Conditions	Oligohydramnios
Interventions	Sildenafil 25 MG, L-Arginine, 1000 Mg Oral Tablet (Drug)
Dates	start 2024-09-01, primary completion 2025-09-15 (estimated), completion 2025-12-31 (estimated), first posted 2025-08-21, last updated 2025-08-21
Locations	2 sites in Egypt

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
sildn arm	Active comparator	Drug: Sildenafil 25 MG	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.
L- argin arm	Active comparator	Drug: L-Arginine, 1000 Mg Oral Tablet	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.

Sildenafil 25 MG (Drug), also known as Viagra: Sildenafil is a vasodilator drug which improve blood supply to placenta.Therefore, it should improve idiopathic oligohydramnios.
L-Arginine, 1000 Mg Oral Tablet (Drug), also known as L- arginine: Aminoacid with vasodilator property which improve blood supply to placenta.Therefore, it should improve idiopathic oligohydramnios.

+Outcome measures

Primary outcomes

Improvement of amniotic fluid index [two hours before cesarean section]: Amniotic fluid index level measured before delivery.

Secondary outcomes

NICU admission [first day after delivery]: NICU admissions rate of the neonates in the study
APGAR score [5 minutes after delivery]: measuring APGAR score for the neonates in the study

+Eligibility

Sex: Female, ages: 18 Years to 35 Years, accepts healthy volunteers

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.

+Locations (2)

Facility	City	Country	Status
Kafrelsheikh University Hospital	Kafr ash Shaykh, Kafrelsheikh	Egypt	Active not recruiting
Kafrelsheokh university hospital	Kafr ash Shaykh, Kafrelsheikh	Egypt	Recruiting

+Investigators

Dalia S Zolfakar, PHD, Study director, daliasamir94@gmail.com

My Notes

Public

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