OligohydramniosPhase 2NCT07135037
Comparison Between Treatments of Oligohydramnios
A Phase 2 study testing Sildenafil 25 MG and L-Arginine, 1000 Mg Oral Tablet in people with Oligohydramnios, run by Kafrelsheikh University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oligohydramnios
- What is being tested?
- Sildenafil 25 MG and L-Arginine, 1000 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Sep 2024to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 1 recruiting
- Active, not recruiting
Kafrelsheikh University Hospital
Kafr ash Shaykh, Kafrelsheikh, 33513
- Recruiting
Kafrelsheokh university hospital
Kafr ash Shaykh, Kafrelsheikh, 33513
Ahmed A Ali, Professor, 0020-1005688624, medical_research@kfs.edu.eg
About this study
Official title: Efficacy of L- Arginine Versus Sildenafil in Management of Idiopathic 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.
- Conditions
- Oligohydramnios
- Being tested
- Sildenafil 25 MG, L-Arginine, 1000 Mg Oral Tablet
- Medical subject headings
- Oligohydramnios
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil 25 MGDrug
Also called Viagra
Sildenafil is a vasodilator drug which improve blood supply to placenta.Therefore, it should improve idiopathic oligohydramnios.
L-Arginine, 1000 Mg Oral TabletDrug
Also called L- arginine
Aminoacid with vasodilator property which improve blood supply to placenta.Therefore, it should improve idiopathic oligohydramnios.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: L-Arginine, 1000 Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of amniotic fluid index
Amniotic fluid index level measured before delivery.
Measured: two hours before cesarean section
Secondary outcomes (2)
NICU admission
NICU admissions rate of the neonates in the study
Measured: first day after delivery
APGAR score
measuring APGAR score for the neonates in the study
Measured: 5 minutes after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start1 Sep 2024
- Primary completion15 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OligohydramniosStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibtesam Teleb Mohamed Yousef Gadalla, Kafrelsheikh University
- Investigators
- Dalia S Zolfakar, PHD, Study director, daliasamir94@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135037
- Sponsor's protocol ID
- KFSIRB200-329
- Status last verified
- Sep 2024
- First submitted
- 9 Jun 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of L- Arginine Versus Sildenafil in Management of Idiopathic Oligohydramnios
- ClinicalTrials.gov ID
- NCT07135037
- Acronym / sponsor ID
- KFSIRB200-329
- Conditions
- Oligohydramnios
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sildn arm | Active comparator | Drug: Sildenafil 25 MGIn 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 TabletIn 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sildenafil 25 MGAlso: ViagraSildenafil is a vasodilator drug which improve blood supply to placenta.Therefore, it should improve idiopathic oligohydramnios. | Drug | sildn arm |
| L-Arginine, 1000 Mg Oral TabletAlso: L- arginineAminoacid with vasodilator property which improve blood supply to placenta.Therefore, it should improve idiopathic oligohydramnios. | Drug | L- argin arm |
Primary outcome
Improvement of amniotic fluid index
Time frame: two hours before cesarean section
Amniotic fluid index level measured before delivery.
2 secondary outcomes
NICU admission
Time frame: first day after delivery
APGAR score
Time frame: 5 minutes after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dalia S Zolfakar, PHD study director
daliasamir94@gmail.com
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sildenafil 25 MG and L-Arginine, 1000 Mg Oral Tablet in people with Oligohydramnios, run by Kafrelsheikh University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ibtesam T Gadalla, MBBch (1025193157 ext. 0020, bassmagadalla@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of amniotic fluid index (time frame: two hours before cesarean section). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.