Fetal Renal Artery Doppler Indices in Borderline Isolated Oligohydramnios

Oligohydramnios Clinical Trial

Official title:

Third Trimester Fetal Renal Artery Doppler Indices in Borderline Idiopathic Isolated Oligohydramnios and Relationship Between Neonatal Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02901340
• Other study ID #: 2016/474
• Status: Recruiting
• Phase: N/A
• First received: September 4, 2016
• Last updated: September 14, 2016
• Start date: August 2016
• Est. completion date: December 2016

Study information

• Verified date: September 2016
• Source: Kayseri Education and Research Hospital
• Contact: Erdem SAHIN, Study Principal Investigator
• Phone: +095321688683
• Email: erdemsahin07[@]hotmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to investigate third trimester fetal renal artery doppler indices in borderline idiopathic isolated oligohydramnios and relationship between neonatal outcomes.

Description:

During a routine pregnancy examination at 34-37 weeks gestation, the fetus was evaluated using ultrasound with the Toshiba Xario 200 3.5-megahertz probe. Fetal biometric measurements were obtained and placental structure and the amniotic fluid amount were evaluated in four quadrants. After detailed ultrasonography of the fetus, eligible pregnant women were included in the study.

Borderline idiopathic isolated oligohydramnios was defined according to the four quadrants technical with ultrasound examination and diagnosed with amniotic fluid index >5.0 and ≤8.0cm. After first ultrasound examination all patients in borderline isolated oligohydramnios group were hydrated with one to two liters of water daily. All patients monitored with non stress test and amniotic fluid index twice weekly until delivery after treatment with hydration.

For evaluating renal artery blood flow, an axial image of the fetal abdomen was obtained at the level of the fetal kidneys. Using color flow Doppler, the renal arteries were evaluated at the level of their origin from the abdominal aorta. The Doppler gate was placed within the lumen in a straight segment of the vessel. A minimum of three consecutive waveforms was used to calculate the PI. The umbilical artery Doppler measurements were studied in a free loop of cord, far from the fetus and placenta. pulsatile index and resistance index values were recorded.

The study consisted of two groups. The first group was formed of the patients who had normal amniotic volume and meets the inclusion criteria. In second group the investigators included patients who diagnosed borderline idiopathic isolated oligohydramnios. After delivery the investigators compared fetal renal artery doppler indices and neonatal outcomes between groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• singleton pregnancies

• between 34-37 gestational weeks

• the age of them ranged from 18 to 35 years

Exclusion Criteria:

• uteroplacental insufficiency

• preeclampsia

• chronic hypertension

• collagen vascular disease

• nephropathy

• chromosomal abnormalities

• congenital abnormalities, especially those associated with impaired urine production

• growth restriction

• ruptured fetal membranes

• twin pregnancies

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Oligohydramnios

Intervention

Dietary Supplement:
• one to two liters of water daily

Locations

Country	Name	City	State
Turkey	Kayseri Training and Research Hospital	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
Kayseri Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fetal renal artery pulsatile index in borderline idiopathic isolated oligohydramnios		4 months	No