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. 2019 Mar 29;2019(3):CD012212. doi: 10.1002/14651858.CD012212.pub2

Najafianaraki 2010.

Methods Design: double‐blind randomized controlled trial
 Country: Iran
 Multisite: no
 International: no
 Treatment duration: intraoperative period
 Follow‐up: 24 hours postoperatively
 Operative procedure(s): Shirodkar's operation (cervical cerclage)
 Randomization unit: participants
 Analysis unit: individual
Participants
  1. 120 participants enrolled

  2. ASA I to II female participants aged 20 to 40 years undergoing elective cervical cerclage


Exclusion criteria included:
  1. history of heart disease;

  2. pulmonary disease;

  3. liver disease;

  4. kidney disease;

  5. pre‐existing nausea and vomiting.


Randomized to:
  1. control group (n = 60, 50%);

  2. intervention group (n = 60, 50%).


Main characteristics of participants:
  1. age (mean): control group 26.9 years; intervention group 25.2 years;

  2. number of females/males: 120/0.

Interventions
  1. Control: Ringer's lactate 2 mL/kg/hour spent fasting, initiated preoperatively

  2. Intervention: Ringer's lactate 2 mL/kg/hour spent fasting, initiated preoperatively; then given Ringer's lactate 10 mL/kg


Co‐interventions: none stated
Outcomes
  1. Vomiting was assessed as a dichotomous outcome.

  2. Nausea was assessed on an ordinal scale as "mild", "moderate", or "severe".

  3. Nausea was also reported as a dichotomous outcome.

  4. These outcomes were reported for the cumulative postoperative period up to discharge, which was 14 hours after the operation.

Notes Trial registration: not stated
 Funder: not stated
 A priori sample size estimation: not stated
 Conducted: dates not stated
 Declared conflicts of interest: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomization was completed using a table of random numbers.
Allocation concealment (selection bias) Low risk Randomization was completed using a table of random numbers.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk It is not stated that participants or surgical personnel were blind to group allocation.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk It is stated that ward staff were blinded to group allocation, but no outcome assessor is explicitly identified.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No withdrawals were stated.
Selective reporting (reporting bias) Low risk All outcomes were reported.
Other bias Low risk There were no other sources of bias.