Comparison Between Treatments of Oligohydramnios

Kafrelsheikh University

Status and phase: Enrolling; Phase 2

Conditions: Oligohydramnios

Treatments: Drug: L-Arginine, 1000 Mg Oral Tablet; Drug: Sildenafil 25 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT07135037

KFSIRB200-329

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

sildn arm

Active Comparator group

Description:

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.

Treatment:

Drug: Sildenafil 25 MG

L- argin arm

Active Comparator group

Description:

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.

Treatment:

Drug: L-Arginine, 1000 Mg Oral Tablet