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

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ClinicalTrials.gov Identifier: NCT03536689
Recruitment Status : Completed
First Posted : May 25, 2018
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Rajavithi Hospital

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

Condition or disease Intervention/treatment Phase
Pregnancy Related Diagnostic Test: Amniotic fluid index Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Factorial 2-by-2 open labeled randomised controlled trial
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Randomized Controlled Trial of Amniotic Fluid Index Compared Between After Upright and Left Lateral Decubitus Maternal Position Change
Actual Study Start Date : February 20, 2018
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

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 Name: 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 Name: AFI




Primary Outcome Measures :
  1. Amniotic fluid index change after maternal position change [ Time Frame: 15 minutes ]
    Amniotic fluid index before and after maternal position change



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Ages Eligible for Study:   20 Years to 34 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536689


Locations
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Thailand
Rajavithi Hospital
Bangkok, Thailand, 10400
Sponsors and Collaborators
Rajavithi Hospital
Investigators
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Principal Investigator: Tirawat Chotkittikul, MD Rajavithi Hospital
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Responsible Party: Rajavithi Hospital
ClinicalTrials.gov Identifier: NCT03536689    
Other Study ID Numbers: RAJAAFI001
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rajavithi Hospital:
Amniotic fluid index
Additional relevant MeSH terms:
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Pressure Ulcer
Skin Ulcer
Skin Diseases