Comparison of Amniotic Fluid Index Between Before and After Maternal Position Change in Upright and Left Lateral Decubitus Position

NCT ID: NCT03536689

Last Updated: 2020-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-20

Study Completion Date

2018-09-30

Brief Summary

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Comparison of amniotic fluid index between before and after maternal position change in Upright and left lateral decubitus maternal position

Detailed Description

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Amniotic fluid has many important roles in fetal development such as the development of the digestive tract and respiratory system. The quantity of amniotic fluid can be measured by ultrasonography, measuring the deepest pocket in 4 quadrants of uterus then summarize as one value known as "amniotic fluid index"(AFI). The AFI has the normal range between 5-25 cm. The low AFI (\< 5 cm) is associated with abnormal fetal heart rate, and the abnormal AFI does affect to the treatment during the antepartum and intrapartum phase. However , there is the study shown that when compared to the single deepest pocket (SDP) , AFI could detect the oligohydramnios more which might led to the unnecessary labor induction or operative delivery without the significant change of perinatal outcome. To increase the accuracy of AFI, we theorize that maternal position change might affect the amniotic fluid position which would increase the visual of the amniotic fluid as well.

Conditions

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Pregnancy Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Factorial 2-by-2 open labeled randomised controlled trial
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Upright maternal position change

The participant will be measured by ultrasonograhy for amniotic fluid index in supine position before maternal position change, then she will do the upright position for 5 minute. After 5 minute of upright position , she will lie down in supine position and she will be measured by ultrasonograhy for amniotic fluid index after upright position.

Group Type EXPERIMENTAL

Amniotic fluid index

Intervention Type DIAGNOSTIC_TEST

Ultrasonography of the amniotic fluid level in each 4 quadrants of uterus then summerize as one value to measure the quantity of amniotic fluid index

Left lateral decubitus maternal position change

the participant will be measured by ultrasonograhy for amniotic fluid index in supine position before maternal position change, then she will do the left lateral decubitus position for 5 minutes. After 5 minutes of left lateral decubitus position , she will lie down in supine position and she will be measured by ultrasonograhy for amniotic fluid index after left lateral decubitus position.

Group Type EXPERIMENTAL

Amniotic fluid index

Intervention Type DIAGNOSTIC_TEST

Ultrasonography of the amniotic fluid level in each 4 quadrants of uterus then summerize as one value to measure the quantity of amniotic fluid index

Interventions

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Amniotic fluid index

Ultrasonography of the amniotic fluid level in each 4 quadrants of uterus then summerize as one value to measure the quantity of amniotic fluid index

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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AFI

Eligibility Criteria

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Inclusion Criteria

* Pregnant women age 20-34 years whose gestational age was confirmed by ultrasonography before 24 weeks of gestation

Exclusion Criteria

* Pregnant women with multifetal pregnancy
* Pregnant women who have underlying disease
* Pregnant women who have the history of premature rupture of amniotic membrane
* Pregnant women who have amniotic fluid index below 5 cm (oligohydramnios)
* Pregnant women who have amniotic fluid index more than 25 cm (polyhydramnios)
* Pregnant women whose her baby has the fetal anomaly
Minimum Eligible Age

20 Years

Maximum Eligible Age

34 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Department of Medical Services Ministry of Public Health of Thailand

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tirawat Chotkittikul, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Medical Services Ministry of Public Health of Thailand

Locations

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Rajavithi Hospital

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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RAJAAFI001

Identifier Type: -

Identifier Source: org_study_id

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