Protocol summary
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Study aim
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The effects of Propofol and Midazolam on postpartum maternity blues after cesarean delivery in women referring to Kerman Afzalipour hospital in 2016-2017
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Design
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In this clinical trial with control group, parallel group and double blinded, patients randomly divided in two groups (100 patients in each group) using statistical software (random allocation sequence). first group received Propofol and Midazolam administrated for patients in control group.
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Settings and conduct
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This study was conducted in Kerman Afzalipour hospital and patients, physician and data analysor were masked.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Pregnant women with cesarean indication
Exclusion criteria: Using antidepressants drugs; Experience of other psychological problems under treatment; Experience of acutely debilitating or life-threatening illnesses; Drug abuse or incitement to any form; Development of anesthesia complications during cesarean section; Stillbirth during cesarean section
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Intervention groups
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In this study patients in intervention group received Propofol and patients in control group received Midazolam after delivery.
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Main outcome variables
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Postpartum maternity blues
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:
IRCT20190819044559N2
Registration date:
2019-11-07, 1398/08/16
Registration timing:
retrospective
Last update:
2026-06-28, 1405/04/07
Update count:
1
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Registration date
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2019-11-07, 1398/08/16
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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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Expected recruitment start date
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2017-04-04, 1396/01/15
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Expected recruitment end date
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2018-03-16, 1396/12/25
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Actual recruitment start date
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2017-04-04, 1396/01/15
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Actual recruitment end date
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2018-02-15, 1396/11/26
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Trial completion date
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2018-02-15, 1396/11/26
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Scientific title
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The effect of Propofol and Midazolam on post partum maternity blues after cesarean delivery in women referring to Kerman Afzalipour hospital in 2016-2017
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Public title
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The effect of Propofol and Midazolam on post partum maternity blues
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Pregnant women with cesarean indication
Exclusion criteria:
Using antidepressants drugs
Experience of other psychological problems under treatment
Experience of acutely debilitating or life-threatening illnesses
Drug abuse or consumption of incitement medications in any form
Development of anesthesia complications during the cesarean section
stillbirth during the cesarean section
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Age
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From 18 years old to 35 years old
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Gender
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Female
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Phase
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1
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Groups that have been masked
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- Participant
- Investigator
- Data analyser
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Sample size
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Target sample size:
200
Actual sample size reached:
200
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study patients randomly divided to intervention and control groups (100 patients in each group) using random allocation sequence with SAS statistical software. according to this method, a simple randomization list product and patients` involvement in each group determine base on their order entry. we used Sequentially numbered, sealed, opaque envelopes for allocation concealment. patients (individuals) were the randomization units.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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Patients, main investigator and data analyser were masked of patients allocation.
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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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2017-04-03, 1396/01/14
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Ethics committee reference number
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KMU.IR.REC.1396.1267
Health conditions studied
1
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Description of health condition studied
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post partum maternity blues
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ICD-10 code
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F53.0
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ICD-10 code description
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Mental and behavioural disorders associated with the puerperium, not elsewhere classified
Primary outcomes
1
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Description
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Postpartum maternity blues
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Timepoint
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After Cesarean section in recovery, two days after cesarean section, two weeks after cesarean section
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Method of measurement
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Edinburg questionnaire
Intervention groups
1
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Description
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Intervention group: receiving 20-75µg/kg/min Propofol after delivery using infusion pump.
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Category
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Treatment - Other
2
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Description
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Control group: receiving 1-2 mg Midazolam after delivery, Single dose
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Category
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Treatment - Other
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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Kerman 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available