ClinicalTrials.gg
RecruitingNCT07135037Updated Aug 21, 2025

Comparison Between Treatments of Oligohydramnios

A Phase 2 interventional study of Sildenafil 25 MG and L-Arginine, 1000 Mg Oral Tablet in Oligohydramnios, sponsored by Kafrelsheikh University. Recruiting at 2 sites in Egypt. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-21.

Sponsored by Kafrelsheikh University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Registered 9 months after the study started (first participant enrolled Sep 2024, registered Jun 2025).
  • Started Sep 2024; still recruiting 2 years 2 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Oligohydramnios

Browse trials for

03

In context

Oligohydramnios

25 studies on the registry are indexed under Oligohydramnios; 5 are open to participants now.

This study's planned enrollment of 40 is below the median of 91 across 16 interventional studies indexed under Oligohydramnios.

Browse Oligohydramnios studies →

Lead sponsor

Kafrelsheikh University is the lead sponsor of 294 studies on the registry; 114 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Women complaining of other obstetric disorder such as, PPROM, preeclampsia, or diabetes.
  • Women with chronic illness such as, chronic hypertension, disease or kidney disease.
  • Women who received other treatments for oligohydramnios in current pregnancy.
  • Women who smoke.
  • Fetuses with major congenital anomaly.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    sildn arm

    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

  • Active comparator
    L- argin arm

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

    Also known as: Viagra

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

    Also known as: L- arginine

06

What researchers measure

Primary outcomes

  1. Improvement of amniotic fluid index

    Amniotic fluid index level measured before delivery.

    Time frame: two hours before cesarean section

Secondary outcomes

  1. NICU admission

    NICU admissions rate of the neonates in the study

    Time frame: first day after delivery

  2. APGAR score

    measuring APGAR score for the neonates in the study

    Time frame: 5 minutes after delivery

07

Study locations

1 of 2 sites recruiting
  • Kafrelsheikh University Hospital
    Kafr ash Shaykh, Kafrelsheikh 33513, Egypt
    Active, not recruiting

    Not enrolling at this site.

  • Kafrelsheokh university hospital
    Kafr ash Shaykh, Kafrelsheikh 33513, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2024 (actual). Primary completion is estimated for Sep 2025, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 9, 2025
First posted
Aug 21, 2025
StartActual
Sep 1, 2024
Primary completionEst.
Sep 15, 2025
CompletionEst.
Dec 31, 2025
Last update
Aug 21, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07135037
Responsible party
Ibtesam Teleb Mohamed Yousef Gadalla (principle investigator, Kafrelsheikh University) — Principal investigator
First posted
Aug 21, 2025
Start date
Sep 1, 2024
Primary completion
Sep 15, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Aug 21, 2025

Study contacts

Ibtesam T Gadalla, MBBch
Contact
bassmagadalla@gmail.com
1025193157 ext. 0020
Mostafa F El-lakany, PHD
Contact
Mfe_2014@yahoo.com
10116083210 ext. 0020
Dalia S Zolfakar, PHD
study director · daliasamir94@gmail.com

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Sildenafil · Arginine

Start the discussion