Protocol summary
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Study aim
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Comparison of the effects of oral glucose solution or maternal abdominal palpation on non stress test.
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Design
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A randomized clinical trial, with two intervention groups of 150 pregnant women, between November 2018 to September 2019.
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Settings and conduct
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At Fatemieh Hospital in Hamadan city, under the same conditions as the rest in a quiet room, left lateral position, and empty bladder, the research units after completion of the consent form, are randomly divided into 3 groups (Three groups of 50 people), in one group administration of 50g/250cc of water and in another group, the abdominal palpation of the mother (Leopold maneuver) is carried out in one or two times and the movements of the fetus are graded ( If there is no movement, zero score, if the mother feels the movements of the fetus, score 1, if the examiner feels the movements of the fetus score 2 and if the examiner sees the movements of the fetus score 3, then score 2 or 3 are selected).
Non Stress Test for 20 minutes along with cardiac monitoring, movements and fetal heart rate is recorded. One group is also checked with no intervention as a control group.
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Participants/Inclusion and exclusion criteria
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- Age 18 to 35
- Gestational age 34 to 41 weeks
- Single pregnancy
- No history of infertility
- regular pregnancy care
- Not any illness in pregnancy (diabetes, blood pressure and ...)
- normal glucose tolerance test at 28-24 weeks of gestation
- No smoking
- No infection of Hydramnios, Intrauterine death and ...
- No recognize congenital anomalies of the fetus
- Not use narcotics, opiates or other drugs by the mother
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Intervention groups
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The research units were randomly divided into two groups, one group administered 50 grams of oral sugars in 250 cc of water and in the other group, the abdominal palpation of the Leopold maneuvered, one or two times with 10 minutes interval, is done.
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Main outcome variables
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Fetal movement
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2012082110635N1
Registration date:
2012-12-31, 1391/10/11
Registration timing:
prospective
Last update:
2018-12-15, 1397/09/24
Update count:
2
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Registration date
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2012-12-31, 1391/10/11
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice chancellor for Research and Technology Research, Hamadan medical university of Iran.
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Expected recruitment start date
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2018-12-22, 1397/10/01
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Expected recruitment end date
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2019-09-23, 1398/07/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Assessment of oral glucose solution & maternal abdominal palpation effect on fetal non stress test.
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Public title
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Assessment of oral glucose solution & maternal abdominal palpation effect on fetal non stress test.
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Purpose
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Diagnostic
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age 18 to 35 years old
Gestational age 34 to 41 weeks
Single pregnancy
Infertility failure
Having regular pregnancy care
The absence of any illness in pregnancy (diabetes, blood pressure and ...)
Having a normal glucose tolerance test at 28-24 weeks of gestation
No smoking
No Hydramnios and Intrauterine death
no recognize congenital anomalies of the fetus to
Do not use narcotics, opiates or other drugs by the mother
Exclusion criteria:
abnormal fetal heart rate
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Age
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To 35 years old
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Gender
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Female
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Phase
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2-3
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Groups that have been masked
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Sample size
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Target sample size:
150
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Research units are randomly assigned to one of two study groups using random numbers and each group receives one of the relevant interventions.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Single blind, data analyzer will be blind.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-10-13, 1397/07/21
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Ethics committee reference number
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IR.UMSHA.REC.1397.477
Health conditions studied
1
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Description of health condition studied
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Non Stress Test
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ICD-10 code
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O68.9
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ICD-10 code description
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Labour and delivery complicated by fetal stress, unspecified
Primary outcomes
1
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Description
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fetal movement
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Timepoint
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20 minutes after ingestion of 50g of glucose in 250ml of water or Immediately after maternal abdominal palpation.
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Method of measurement
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fetal non stress test
2
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Description
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Fetal heart rate
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Timepoint
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20 minutes after ingestion of 50g of glucose in 250ml of water or Immediately after maternal abdominal palpation.
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Method of measurement
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fetal non stress test
Secondary outcomes
1
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Description
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Increase fetal heart rate
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Timepoint
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At the time of testing
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Method of measurement
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Fetal heart ratemonitoring
Intervention groups
1
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Description
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All pregnant women will assess in the same conditions, such as same quiet room and semi recumbent position. Women with non reactive NST randomly assign for oral ingestion of 50g of glucose in 250ml of water, then 20 min monitoring will be done after 30 min of intervention.
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Category
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Diagnosis
2
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Description
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All pregnant women will assess in the same conditions, such as same quiet room and semi recumbent position. Women with non reactive NST randomly selected for 1 or 2 times abdominal palpation such as Leopold maneuver with 10 min interval, then 20 min monitoring will be done immediately after intervention.
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Category
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Diagnosis
3
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Description
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Control group:
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Category
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Diagnosis
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice Chancellor for Research and Thecnology Research, Hamadan university of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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When the data will become available and for how long
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To whom data/document is available
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Under which criteria data/document could be used
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From where data/document is obtainable
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What processes are involved for a request to access data/document
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Comments
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