NCT07135037

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2024

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 21, 2025

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 21, 2025

Status Verified

September 1, 2024

Enrollment Period

1 year

First QC Date

June 9, 2025

Last Update Submit

August 13, 2025

Conditions

Oligohydramnios

Outcome Measures

Primary Outcomes (1)

  • Improvement of amniotic fluid index

    Amniotic fluid index level measured before delivery.

    two hours before cesarean section

Secondary Outcomes (2)

  • NICU admission

    first day after delivery

  • APGAR score

    5 minutes after delivery

Study Arms (2)

sildn arm

ACTIVE COMPARATOR

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.

Drug: Sildenafil 25 MG

L- argin arm

ACTIVE COMPARATOR

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.

Drug: L-Arginine, 1000 Mg Oral Tablet

Interventions

Sildenafil 25 MGDRUG

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

Also known as: Viagra
sildn arm
L-Arginine, 1000 Mg Oral TabletDRUG

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

Also known as: L- arginine
L- argin arm

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kafrelsheikh University Hospital

Kafr ash Shaykh, Kafrelsheikh, 33513, Egypt

ACTIVE NOT RECRUITING

Kafrelsheokh university hospital

Kafr ash Shaykh, Kafrelsheikh, 33513, Egypt

RECRUITING

MeSH Terms

Conditions

Oligohydramnios

Interventions

Sildenafil CitrateArginineTablets

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingAmino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, EssentialDosage FormsPharmaceutical Preparations

Study Officials

  • Dalia S Zolfakar, PHD

    daliasamir94@gmail.com

    STUDY DIRECTOR

Central Study Contacts

Ibtesam T Gadalla, MBBch

CONTACT

1025193157bassmagadalla@gmail.com

Mostafa F El-lakany, PHD

CONTACT

10116083210Mfe_2014@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

June 9, 2025

First Posted

August 21, 2025

Study Start

September 1, 2024

Primary Completion

September 15, 2025

Study Completion

December 31, 2025

Last Updated

August 21, 2025

Record last verified: 2024-09

Locations

EG(2)