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

Randomized Controlled Trial of Amniotic Fluid Index Compared Between After Upright and Left Lateral Decubitus Maternal Position Change

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

Study Overview

• Status: Completed
• Conditions: Pregnancy Related
• Intervention / Treatment: Diagnostic test: Amniotic fluid index

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Rajavithi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Diagnostic test: 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; Other Names: AFI
Experimental: 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.	Diagnostic test: 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; Other Names: AFI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amniotic fluid index change after maternal position change	Amniotic fluid index before and after maternal position change	15 minutes

Collaborators and Investigators

• Sponsor: Rajavithi Hospital
• Investigators: Principal Investigator: Tirawat Chotkittikul, MD, Rajavithi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2018
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: May 14, 2018
• First Submitted That Met QC Criteria: May 14, 2018
• First Posted (Actual): May 25, 2018

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Amniotic fluid index
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Pressure Ulcer
• Other Study ID Numbers: RAJAAFI001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No