Effects of misoprostol and gum chewing on intestinal motility after cesarean section
Design
This study is a single blind clinical trial.
Settings and conduct
324 pregnant women more than 18 years with single pregnancy candidate cesarean will enter in three intervention groups.The patient is not aware of the intervention type.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18-45 years old; single pregnancy; candidate for elective cesarean section (non-emergency).
Exclusion criteria: changing the type of anesthesia to the general; presence of clear peritonitis or sepsis; history of previous bowel surgery; thyroid disease; cardiovascular, blood and liver disease; inflammatory bowel disease; history of chronic constipation; history of misoprostol hypersensitivity; electrolyte imbalance; history of allergy to acetaminophen.
Intervention groups
We prescribe 600 milligram misoprostol rectal in cesarean after delivery placenta.
The second group received chewing gum 2 hours after the chewing gum for up to 24 hours each day for 3 hours.
The third group received suppository of placebo.
Main outcome variables
Effects of misoprostoland gum chewing on intestinal motility after cesarean section
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N74
Registration date:2018-04-13, 1397/01/24
Registration timing:retrospective
Last update:2018-04-13, 1397/01/24
Update count:0
Registration date
2018-04-13, 1397/01/24
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of misoprostol and chewing gum on intestinal movements after cesarean delivery
Public title
Comparison of the effect of misoprostol and chewing gum on intestinal movements after cesarean delivery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
َAge: 18-45 years old
Single pregnancy pregnancy
Candidate for elective cesarean section (non-emergency)
Exclusion criteria:
Changing the type of anesthesia to the general
Presence of clear peritonitis or sepsis
History of previous bowel surgery
Thyroid disease
Cardiovascular, blood and liver disease
Inflammatory bowel disease, history of chronic constipation
History of misoprostol hypersensitivity
Electrolyte imbalance
History of allergy to acetaminophen
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
324
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with random numbers
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient is not aware of the treatment received. Participant is blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences