Fetal Renal Artery Doppler Indices in Borderline Isolated Oligohydramnios

September 14, 2016 updated by: Erdem Sahin, Kayseri Education and Research Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kayseri, Turkey, 38000
        • Recruiting
        • Kayseri Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The study population was consisted of 2 groups and included pregnant women in between 34 and 37. weeks of gestation for both groups. The normal pregnancy group was consisted of 100 healthy pregnant women whom excluded borderline idiopathic isolated oligohydramniosis , the main group was consisted of 40 pregnant women with diagnosed borderline idiopathic isolated oligohydramniosis.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Borderline isolated oligohydramnios

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.

The borderline idiopathic isolated oligohydramnios group was formed of the patients who meets the inclusion criteria and between 34-37 weeks gestation (n:40)

Control group
The control group was formed of the patients who had normal amniotic volume and 34-37 weeks gestation who meets the inclusion criteria (n:100)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fetal renal artery pulsatile index in borderline idiopathic isolated oligohydramnios
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

September 4, 2016

First Submitted That Met QC Criteria

September 14, 2016

First Posted (Estimate)

September 15, 2016

Study Record Updates

Last Update Posted (Estimate)

September 15, 2016

Last Update Submitted That Met QC Criteria

September 14, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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