Health TrialsbyHealthPanel

Comparison Between Treatments of Oligohydramnios

ConditionOligohydramnios
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorKafrelsheikh University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sildenafil 25 MG

    Drug

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

  • L-Arginine, 1000 Mg Oral Tablet

    Drug

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: sildn armActive comparator 1 intervention
Group B: L- argin armActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kafrelsheikh University

Lead sponsor

Source ClinicalTrials.gov
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