PregnancyNCT02046642
Effect of Maternal Rest and Resting Positions on Amniotic Fluid
A study testing Maternal rest in left lateral position and Maternal rest in right lateral position in people with Pregnancy, run by Kafkas University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Maternal rest in left lateral position and Maternal rest in right lateral position
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2013to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- rupture of membranes
- congenital malformations
- intra uterine growth restriction
- an abnormal non-stress test
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kafkas University School of Medicine, Department of Obstetrics and Gynecology
Kars, 36000
About this study
Official title: Effect of Maternal Rest and Resting Positions on Amniotic Fluid: A Randomized Prospective Study
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.
Read more
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.
Read the detailed description
In order to study the effects of maternal rest in the right or left lateral decubitus position on amniotic fluid index, the investigators assigned the patients into groups 1 and 2 by using a computerized program and sealed cards (first investigator, K.Ü.). The department's head nurse used the sealed cards to allocate the participants into groups.
Previous studies detected amniotic fluid index increase during maternal rest in left lateral decubitus position. Thus, the primary outcome of the study was to detect the same increase in the left lateral position, and in the right lateral position as an alternative to the former position. The secondary outcome was to determine the role of resting alone.
The amniotic fluid index change values obtained in a previous study were used to perform power analysis. Power analysis indicated that in order to achieve an increase from the initial amniotic fluid index value of 153.76 ± 38.47 to the 15th minute value of 185.42 ± 46.89 with 90% of power at one side alpha of 0.05, at least 34 women were needed in each group. Thus, 76 women were invited to participate in the study in order to avoid unpredictable errors.
According to the predefined study design, all participants had an initial AFI measurement. Following the initial AFI measurements, women in Group 1 ( maternal rest in left lateral position) rested in the left lateral position for 15 minutes and then rested in the right lateral position for another 15 minutes. Women in Group 2 (maternal rest in the right lateral position) started resting in the right lateral position for 15 minutes and then rested in the left lateral position for another 15 minutes. The AFI values of both groups were measured before interventions, at the end of first 15 minutes and at the end of second 15 minutes. Depending on the study design it was impractical to blind either the observer or the participants. The well-being of the fetus and the mother were assessed intermittently by recording the fetal heart rate trace and measuring the maternal blood pressure and pulse rate.
In order to avoid the inter-observer variation, a single examiner (Second investigator, M.Ç.) measured all AFIs by using a high resolution ultrasound apparatus (Voluson 730 Pro; General Electric-Kretztechnik, Zipf, Austria) equipped with a convex transducer (2-7 MHz) while the women were on their back in a semi-recumbent position. AFI values were calculated according to the technique described by Phelan et al.The vertically measured values of the four amniotic fluid quadrants were added to determine AFI. The same measurement was repeated immediately and an average of two repetitive measurements determined the AFI. Intra-observer variations were assessed by using the repetitive AFI measurements.
- Conditions
- Pregnancy
- Being tested
- Maternal rest in left lateral position, Maternal rest in right lateral position
- Keywords
- Amniotic fluid index;, amniotic fluid volume;, intervention studies;, maternal care patterns;, mother-fetus relationships;, rest;, sonography;, transplacental exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal rest in left lateral positionBehavioural
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 right lateral positionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Maternal rest in right lateral position |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 minutes
Secondary outcomes (1)
The role of maternal rest alone
The mothers rested 15 minutes at left and 15 minutes at right lateral positions in both groups. Thus, if a difference was observed at the end of the rest period in both groups, then, the specific lateral position,had more contribution to the observed amniotic fluid index change than the rest alone.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startMar 2013
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafkas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kahraman Ulker, Kafkas University
- Investigators
- Kahraman Ülker, MD, Principal investigator, Kafkas University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02046642
- Sponsor's protocol ID
- KafkasUniversity1
- Status last verified
- Jan 2014
- First submitted
- 23 Jan 2014
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21460147Ulker 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.
PubMed 22535717Ulker 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.
PubMed 22696825Ulker 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.
PubMed 23716516
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Maternal Rest and Resting Positions on Amniotic Fluid: A Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT02046642
- Acronym / sponsor ID
- KafkasUniversity1
- Conditions
- Pregnancy
- Keywords
- Amniotic fluid index;, amniotic fluid volume;, intervention studies;, maternal care patterns;, mother-fetus relationships;, rest;, sonography;, transplacental exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Kafkas UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 28 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In order to study the effects of maternal rest in the right or left lateral decubitus position on amniotic fluid index, the investigators assigned the patients into groups 1 and 2 by using a computerized program and sealed cards (first investigator, K.Ü.). The department's head nurse used the sealed cards to allocate the participants into groups.
Previous studies detected amniotic fluid index increase during maternal rest in left lateral decubitus position. Thus, the primary outcome of the study was to detect the same increase in the left lateral position, and in the right lateral position as an alternative to the former position. The secondary outcome was to determine the role of resting alone.
The amniotic fluid index change values obtained in a previous study were used to perform power analysis. Power analysis indicated that in order to achieve an increase from the initial amniotic fluid index value of 153.76 ± 38.47 to the 15th minute value of 185.42 ± 46.89 with 90% of power at one side alpha of 0.05, at least 34 women were needed in each group. Thus, 76 women were invited to participate in the study in order to avoid unpredictable errors.
According to the predefined study design, all participants had an initial AFI measurement. Following the initial AFI measurements, women in Group 1 ( maternal rest in left lateral position) rested in the left lateral position for 15 minutes and then rested in the right lateral position for another 15 minutes. Women in Group 2 (maternal rest in the right lateral position) started resting in the right lateral position for 15 minutes and then rested in the left lateral position for another 15 minutes. The AFI values of both groups were measured before interventions, at the end of first 15 minutes and at the end of second 15 minutes. Depending on the study design it was impractical to blind either the observer or the participants. The well-being of the fetus and the mother were assessed intermittently by recording the fetal heart rate trace and measuring the maternal blood pressure and pulse rate.
In order to avoid the inter-observer variation, a single examiner (Second investigator, M.Ç.) measured all AFIs by using a high resolution ultrasound apparatus (Voluson 730 Pro; General Electric-Kretztechnik, Zipf, Austria) equipped with a convex transducer (2-7 MHz) while the women were on their back in a semi-recumbent position. AFI values were calculated according to the technique described by Phelan et al.The vertically measured values of the four amniotic fluid quadrants were added to determine AFI. The same measurement was repeated immediately and an average of two repetitive measurements determined the AFI. Intra-observer variations were assessed by using the repetitive AFI measurements.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maternal rest in left lateral position | Active comparator | Behavioral: Maternal rest in left lateral positionwomen 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. |
| Maternal rest in right lateral position | Active comparator | Behavioral: Maternal rest in right lateral positionWomen 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maternal rest in left lateral positionAfter 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 | Behavioural | Maternal rest in left lateral position |
| Maternal rest in right lateral positionAfter 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 | Behavioural | Maternal rest in right lateral position |
Primary outcome
Significant increase or decrease of amniotic fluid index during maternal rest in the left and right lateral positions
Time frame: 30 minutes
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
1 secondary outcome
The role of maternal rest alone
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2014.
- Background: PubMed 21460147Ulker 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.
- Background: PubMed 22535717Ulker 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.
- Background: PubMed 22696825Ulker 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.
- Background: PubMed 23716516Ulker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kahraman Ülker, MD principal investigator
Kafkas University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternal rest in left lateral position and Maternal rest in right lateral position in people with Pregnancy, run by Kafkas University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant increase or decrease of amniotic fluid index during maternal rest in the left and right lateral positions (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02046642, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2014.