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NCT Number: NCT07135037

Comparison Between Treatments of Oligohydramnios

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.

Recruiting

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Kafrelsheikh University Hospital, Kafr ash Shaykh, Kafrelsheikh, Egypt

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sildenafil 25 MG

Drug

Sildenafil is a vasodilator drug which improve blood supply to placenta.Therefore, it should improve idiopathic oligohydramnios.

Other names: Viagra

L-Arginine, 1000 Mg Oral Tablet

Drug

Aminoacid with vasodilator property which improve blood supply to placenta.Therefore, it should improve idiopathic oligohydramnios.

Other names: L- arginine

Primary outcomes

  1. Improvement of amniotic fluid index

    Time frame: two hours before cesarean section

    Amniotic fluid index level measured before delivery.

Secondary outcomes

  1. NICU admission

    Time frame: first day after delivery

    NICU admissions rate of the neonates in the study

  2. APGAR score

    Time frame: 5 minutes after delivery

    measuring APGAR score for the neonates in the study

Study contacts

Contact information is provided by the study sponsor or research team.

Ibtesam T Gadalla, MBBch

CONTACT

[email protected]

1025193157 ext. 0020

Mostafa F El-lakany, PHD

CONTACT

[email protected]

10116083210 ext. 0020

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 21, 2025
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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