Effect of Maternal Rest and Resting Positions on Amniotic Fluid

NCT02046642 | Completed

• 1 other identifier: KafkasUniversity1
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

Maternal rest in left lateral decubitus position increases fetal urine production rate which in turn increases the estimated amniotic fluid volume (AFV) in uncomplicated pregnancies. The estimated AFV increases faster at initial periods, particularly during the first, second and third 15 minute periods of the maternal rest in the left lateral position. Although at each successive 15 minute period the estimated AFV continues to increase, the increase rate is always less in the following period. The AFV increase curve resembles the characteristics of a saturation curve and finally the estimated AFV increase stops approximately at the second hour. Although maternal rest in left lateral decubitus position increased the estimated AFV in the previous studies, the sole effect of left lateral position or the sole effect of rest was not evaluated, and the results of resting in another position is not known. In addition, it is hard for a pregnant woman to maintain the left lateral position continuously. Rest in the prone position is not practical for a pregnant woman, particularly after the first trimester of the pregnancy and supine position may cause several hypotension related symptoms including nausea, anxiety, lightheadedness, shortness of breath, perspiration, tachycardia and urge to change position. Thus, right lateral position may be an alternative. The purpose of this study is to analyze the effect of maternal rest in the right lateral decubitus position on estimated amniotic fluid volume in comparison with the left lateral position. Because, in both groups the mothers rested, our secondary aim was to obtain data for the contribution of maternal rest to the AFI increase observed in the previous studies.

Conditions

Pregnancy

Keywords

Amniotic fluid index;; amniotic fluid volume;; intervention studies;; maternal care patterns;; mother-fetus relationships;; rest;; sonography;; transplacental exposure

Outcome Measures

Primary Outcomes (1)

• Significant increase or decrease of amniotic fluid index during maternal rest in the left and right lateral positions

  Both intervention group participants rested in the left and right lateral positions 15 minutes for each position. First and second groups started resting in the left and right lateral positions, respectively, and then changed the positions. The primary outcome measures were * Resting in LEFT lateral position for 15 minutes increases or decreases amniotic fluid index * Resting in RIGHT lateral position for 15 minutes increases or decreases amniotic fluid index * Initial position of resting, left or right, effects the amniotic fluid changes

  30 minutes

Secondary Outcomes (1)

• The role of maternal rest alone

  30 minutes

Other Outcomes (1)

• Decrease of pre-specified increased amniotic fluid index after maternal rest in the left lateral decubitus position

  15 minutes

Study Arms (2)

Maternal rest in left lateral position

ACTIVE COMPARATOR

women in "maternal rest in left lateral position" group rested in the left lateral position for 15 minutes and then rested in the right lateral position for another 15 minutes.

Behavioral: Maternal rest in left lateral position

Maternal rest in right lateral position

ACTIVE COMPARATOR

Women in "maternal rest in right lateral position" group started resting in the right lateral position for 15 minutes and then rested in the left lateral position for another 15 minutes.

Behavioral: Maternal rest in right lateral position

Interventions

Maternal rest in left lateral position BEHAVIORAL

After initial amniotic fluid index measurements, the participating pregnant women were instructed to turn their left sides and rest in that position for 15 minutes before a second amniotic fluid index measurement

Maternal rest in left lateral position

Maternal rest in right lateral position BEHAVIORAL

After initial amniotic fluid index measurements, the participating pregnant women were instructed to turn their right sides and rest in that position for 15 minutes before a second amniotic fluid index measurement

Maternal rest in right lateral position

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women with singleton and uncomplicated pregnancies at 36 0/7- 40 0/7 gestational weeks with an amniotic fluid index (AFI) of between 6 and 24 cm.

You may not qualify if:

• any intake of food or liquid within the preceding four hours of amniotic fluid index measurements
• maternal or fetal complications.
• Hypertensive pregnancy disorders
• gestational or pre-gestational diabetes
• maternal vascular disease
• any known chronic maternal illness
• rupture of membranes
• congenital malformations
• intra uterine growth restriction
• an abnormal non-stress test

Sponsors & Collaborators

• Kafkas University: lead

Study Sites (1)

Kafkas University School of Medicine, Department of Obstetrics and Gynecology

Kars, 36000, Turkey (Türkiye)

Location

Related Publications (4)

• Ulker K, Cecen K, Temur I, Gul A, Karaca M. Effects of the maternal position and rest on the fetal urine production rate: a prospective study conducted by 3-dimensional sonography using the rotational technique (virtual organ computer-aided analysis). J Ultrasound Med. 2011 Apr;30(4):481-6. doi: 10.7863/jum.2011.30.4.481.

  PMID: 21460147 BACKGROUND

• Ulker K, Gul A, Cicek M. Correlation between the duration of maternal rest in the left lateral decubitus position and the amniotic fluid volume increase. J Ultrasound Med. 2012 May;31(5):705-9. doi: 10.7863/jum.2012.31.5.705.

  PMID: 22535717 BACKGROUND

• Ulker K, Temur I, Karaca M, Ersoz M, Volkan I, Gul A. Effects of maternal left lateral position and rest on amniotic fluid index: a prospective clinical study. J Reprod Med. 2012 May-Jun;57(5-6):270-6.

  PMID: 22696825 BACKGROUND

• Ulker K, Cicek M. Effect of maternal hydration on the amniotic fluid volume during maternal rest in the left lateral decubitus position: a randomized prospective study. J Ultrasound Med. 2013 Jun;32(6):955-61. doi: 10.7863/ultra.32.6.955.

  PMID: 23716516 BACKGROUND

Study Officials

• Kahraman Ülker, MD

  Kafkas University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, MD

Study Record Dates

• First Submitted: January 23, 2014
• First Posted: January 28, 2014
• Study Start: March 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: January 28, 2014

Record last verified: 2014-01

Locations

TU (1)