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Protocol summary
A randomized clinical trial, with two intervention groups of 100 pregnant women, between November 2018 to September 2019.
A randomized clinical trial, with two intervention groups of 150 pregnant women, between November 2018 to September 2019.
A randomized clinical trial, with two intervention groups of 100150 pregnant women, between November 2018 to September 2019.
کارآزمایی بالینی تصادفی شده، با دو گروه مداخله از 100 خانم باردار، بین آبان 1397 تا شهریور 1398.
کارآزمایی بالینی تصادفی شده، با دو گروه مداخله از 150 خانم باردار، بین آبان 1397 تا شهریور 1398.
کارآزمایی بالینی تصادفی شده، با دو گروه مداخله از 100150 خانم باردار، بین آبان 1397 تا شهریور 1398.
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 two groups, 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.
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.
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 two3 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.
در بیمارستان فاطمیه شهر همدان، در شرايط يكسان مانند انجام آزمايش در اتاق ساكت و وضعیت خوابيده به پهلوي چپ و تخلیه مثانه. واحدهاي پژوهش پس از تمايل و تكميل فرم رضايت نامه، به دو گروه تقسيم مي شوند، در يك گروه تجويز 50 گرم قند خوراكي در 250 سي سي آب صورت مي گيرد و در گروه ديگر لمس شكم مادر در حد مانور لئوپولد يك تا دو بار به فاصله 10 دقيقه انجام مي شود، پس از لمس شكم مادر حركات جنين بدين صورت درجه بندي مي شود ( اگر هيچگونه حركتي وجود نداشته باشد نمره صفر، اگر مادر حركات جنين را احساس نمايد نمره 1، اگر معاينه كننده حركات جنين را احساس نمايد نمره 2 و اگر معاينه كننده حركات جنين را مشاهده كند نمره 3 تعلق مي گيرد سپس در افرادي كه نمره 2 يا3 را كسب مي كنند انتخاب می شوند).
تست بدون استرس به مدت 20 دقيقه با همراهي مانيتورينگ قلبي، تعداد حركات و تعداد ضربان قلب جنين ثبت مي گردد.
در بیمارستان فاطمیه شهر همدان، در شرايط يكسان مانند انجام آزمايش در اتاق ساكت و وضعیت خوابيده به پهلوي چپ و تخلیه مثانه. واحدهاي پژوهش پس از تمايل و تكميل فرم رضايت نامه، به 3 گروه 50 نفره تقسيم مي شوند، در يك گروه تجويز 50 گرم قند خوراكي در 250 سي سي آب صورت مي گيرد و در گروه ديگر لمس شكم مادر در حد مانور لئوپولد يك تا دو بار به فاصله 10 دقيقه انجام مي شود، پس از لمس شكم مادر حركات جنين بدين صورت درجه بندي مي شود ( اگر هيچگونه حركتي وجود نداشته باشد نمره صفر، اگر مادر حركات جنين را احساس نمايد نمره 1، اگر معاينه كننده حركات جنين را احساس نمايد نمره 2 و اگر معاينه كننده حركات جنين را مشاهده كند نمره 3 تعلق مي گيرد سپس در افرادي كه نمره 2 يا3 را كسب مي كنند انتخاب می شوند).
تست بدون استرس به مدت 20 دقيقه با همراهي مانيتورينگ قلبي، تعداد حركات و تعداد ضربان قلب جنين ثبت مي گردد. یک گروه نیز به عنوان گروه کنترل بدون هیچگونه مداخله ایی بررسی می شوند.
در بیمارستان فاطمیه شهر همدان، در شرايط يكسان مانند انجام آزمايش در اتاق ساكت و وضعیت خوابيده به پهلوي چپ و تخلیه مثانه. واحدهاي پژوهش پس از تمايل و تكميل فرم رضايت نامه، به دو3 گروه 50 نفره تقسيم مي شوند، در يك گروه تجويز 50 گرم قند خوراكي در 250 سي سي آب صورت مي گيرد و در گروه ديگر لمس شكم مادر در حد مانور لئوپولد يك تا دو بار به فاصله 10 دقيقه انجام مي شود، پس از لمس شكم مادر حركات جنين بدين صورت درجه بندي مي شود ( اگر هيچگونه حركتي وجود نداشته باشد نمره صفر، اگر مادر حركات جنين را احساس نمايد نمره 1، اگر معاينه كننده حركات جنين را احساس نمايد نمره 2 و اگر معاينه كننده حركات جنين را مشاهده كند نمره 3 تعلق مي گيرد سپس در افرادي كه نمره 2 يا3 را كسب مي كنند انتخاب می شوند). تست بدون استرس به مدت 20 دقيقه با همراهي مانيتورينگ قلبي، تعداد حركات و تعداد ضربان قلب جنين ثبت مي گردد. یک گروه نیز به عنوان گروه کنترل بدون هیچگونه مداخله ایی بررسی می شوند.
General information
Not blinded
Single blinded
notblsingl
1
1
100
150
100150
2013-02-28, 1391/12/10
2018-12-22, 1397/10/01
20132018-0212-2822 00:00:00
2013-12-28, 1392/10/07
2019-09-23, 1398/07/01
20132019-1209-2823 00:00:00
Single blind, data analyzer will be blind.
Single blind, data analyzer will be blind.
يك سويه كور، آنالیز کننده داده ها کور خواهد شد.
يك سويه كور، آنالیز کننده داده ها کور خواهد شد.
Intervention groups
#1
empty
Diagnosis
diagnosis
empty
Control group:
Control group:
empty
گروه کنترل:
گروه کنترل:
Protocol summary
Study aim
Comparison of the effects of oral glucose solution or maternal abdominal palpation on non stress test.
Design
A randomized clinical trial, with two intervention groups of 150 pregnant women, between November 2018 to September 2019.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
- 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
Intervention groups
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.
Main outcome variables
Fetal movement
General information
Reason for update
Acronym
IRCT registration information
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
Registration date
2012-12-31, 1391/10/11
Registrant information
Name
Soodabeh Aghababaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0150
Email address
aghababaii@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research and Technology Research, Hamadan medical university of Iran.
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of oral glucose solution & maternal abdominal palpation effect on fetal non stress test.
Public title
Assessment of oral glucose solution & maternal abdominal palpation effect on fetal non stress test.
Purpose
Diagnostic
Inclusion/Exclusion criteria
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
Age
To 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
Data analyser
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Research units are randomly assigned to one of two study groups using random numbers and each group receives one of the relevant interventions.
Blinding (investigator's opinion)
Single blinded
Blinding description
Single blind, data analyzer will be blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan Medical university of Iran
Street address
Hamadan Medical university; Shahid Fahmideh Ave; Hamadan; Iran.
City
Hamadan
Province
Hamadan
Postal code
65178
Approval date
2018-10-13, 1397/07/21
Ethics committee reference number
IR.UMSHA.REC.1397.477
Health conditions studied
1
Description of health condition studied
Non Stress Test
ICD-10 code
O68.9
ICD-10 code description
Labour and delivery complicated by fetal stress, unspecified
Primary outcomes
1
Description
fetal movement
Timepoint
20 minutes after ingestion of 50g of glucose in 250ml of water or Immediately after maternal abdominal palpation.
Method of measurement
fetal non stress test
2
Description
Fetal heart rate
Timepoint
20 minutes after ingestion of 50g of glucose in 250ml of water or Immediately after maternal abdominal palpation.
Method of measurement
fetal non stress test
Secondary outcomes
1
Description
Increase fetal heart rate
Timepoint
At the time of testing
Method of measurement
Fetal heart ratemonitoring
Intervention groups
1
Description
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.
Category
Diagnosis
2
Description
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.