Objective: To determine the effects of oral glucose solution or maternal abdominal palpation on non stress test.
Design: Experimental design with randomly assigned for one of two interventions: oral glucose solution or maternal abdominal palpation. The samples included 100 women who referring for prenatal care to Fathemieh hospital of Hamadan medical university in Iran.
Setting: participants will be informed of the research aims and the reasons and methods of NST, then those participants who accepted to participate in the study were assisted by the researchers to complete the pregnancy information form. The participants with nonreactive NST will randomly assign to one of the two interventions (oral ingestion of 50g of glucose in 250ml of water or maternal abdominal palpation). NST will administrate after intervention, reactivity and time to reactivity will assess at the end of the 20 minutes and the results will be recorded.
Inclusion criteria consist of: Maternal age ≤35 years; gestational age between 34 and 41 weeks(Novak & Brom 1999, Murray et al 2002); no smoking; no history of polyhidramnios, intrauterine growth retardation and multiple fetus complications ( Reeder et al. 1997; Oncken et al. 2002); no known congenital anomalies; no maternal medical or obstetric complications; no maternal use of narcotics, sedation and other drug.
Intervention: 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 one of two interventions (oral ingestion of 50g of glucose in 250ml of water or maternal abdominal palpation such as Leopold maneuver), then 20 min monitoring will be done after intervention.
Main outcome measures: The criteria of the effect for the intervention is fetal movement with the acceleration of fetal heart rate at least 15 bpm and 15 s in duration appear 20 min after oral glucose ingestion and immediately after abdominal palpation. The NST parameters included: time in minutes of minimum length of NST defined as reactive, number of fetal movements, large acceleration of fetal heart rate, basal fetal heart rate and variable decelerations. The criteria of reactive is two or more FHR accelerations of at least 15 bpm lasting at least 15 seconds in any 20 min period of NST.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012082110635N1
Registration date:2012-12-31, 1391/10/11
Registration timing:prospective
Last update:
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
2013-02-28, 1391/12/10
Expected recruitment end date
2013-12-28, 1392/10/07
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 consist of: Maternal age ≤35 years; gestational age between 34 and 41 weeks(Novak & Brom 1999, Murray et al 2002); no smoking; no history of polyhidramnios, intrauterine growth retardation and multiple fetus complications ( Reeder et al. 1997, Oncken et al. 2002); no known congenital anomalies; no maternal medical or obstetric complications; no maternal use of narcotics, sedation and other drug.
Age
To 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
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
Postal code
Approval date
2012-07-07, 1391/04/17
Ethics committee reference number
1280/9/35/16/پ/د
Health conditions studied
1
Description of health condition studied
Non Stress Test
ICD-10 code
ICD-10 code description
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
empty
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.