search
Back to results

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

Primary Purpose

Pregnancy Related

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Amniotic fluid index
Sponsored by
Rajavithi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pregnancy Related focused on measuring Amniotic fluid index

Eligibility Criteria

20 Years - 34 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Rajavithi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Upright maternal position change

Left lateral decubitus maternal position change

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Amniotic fluid index change after maternal position change
Amniotic fluid index before and after maternal position change

Secondary Outcome Measures

Full Information

First Posted
May 14, 2018
Last Updated
October 20, 2020
Sponsor
Rajavithi Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03536689
Brief Title
Comparison of Amniotic Fluid Index Between Before and After Maternal Position Change in Upright and Left Lateral Decubitus Position
Official Title
Randomized Controlled Trial of Amniotic Fluid Index Compared Between After Upright and Left Lateral Decubitus Maternal Position Change
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
February 20, 2018 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rajavithi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related
Keywords
Amniotic fluid index

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Factorial 2-by-2 open labeled randomised controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Upright maternal position change
Arm Type
Experimental
Arm Description
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.
Arm Title
Left lateral decubitus maternal position change
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Amniotic fluid index
Other Intervention Name(s)
AFI
Intervention Description
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
Primary Outcome Measure Information:
Title
Amniotic fluid index change after maternal position change
Description
Amniotic fluid index before and after maternal position change
Time Frame
15 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tirawat Chotkittikul, MD
Organizational Affiliation
Rajavithi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rajavithi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs