Comparison Between Treatments of Oligohydramnios

Not Applicable

Recruiting

• Conditions: Oligohydramnios
• Interventions: Drug: Sildenafil 25 MG; Drug: L-Arginine, 1000 Mg Oral Tablet

• Registration Number: NCT07135037
• Lead Sponsor: Kafrelsheikh University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-01
• Study First Submitted: 2025-06-09
• Study First Submitted QC: 2025-08-13
• Last Update Submitted: 2025-08-13
• Study First Posted: 2025-08-21
• Last Update Posted: 2025-08-21
• Primary Completion: 2025-09-15
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sildn arm	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	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.

Primary Outcome Measures

Name	Time	Method
Improvement of amniotic fluid index	two hours before cesarean section	Amniotic fluid index level measured before delivery.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Kafrelsheikh University Hospital; 🇪🇬 Kafr Ash Shaykh, Kafrelsheikh, Egypt

Kafrelsheokh university hospital; 🇪🇬 Kafr Ash Shaykh, Kafrelsheikh, Egypt