Reddick 2014.
Study characteristics | ||
Methods | RCT | |
Participants | 50 women were randomised. Setting: Duke Obstetrics outpatient clinics or the Duke University Hospital Birthing Center, USA. Study dates: April 2009 to March 2010. Inclusion criteria: scheduled (non‐labour) caesarean at term (≥ 37 weeks' gestation); no history of thrombophilia; no history of or current venous or arterial thrombosis; aged ≥ 18 years; BMI 18.5 to 35; English literate. Exclusion criteria: hypertension (chronic and pregnancy related); diabetes (insulin‐dependent, type II and gestational); maternal cardiac disease (valvular heart disease, congenital heart disease, cardiomyopathy); substance use (including tobacco, alcohol, and illicit substances); family history of thrombophilia; multiple gestation; sickle cell disease; and lupus/connective tissue disorder. |
|
Interventions |
Group 1 (n = 25): intermittent pneumatic compression during caesarean birth. Women had compression devices (Aircast Venaflow Calf Cuff—DJO, LLC, Vista, CA) placed on their lower extremities.The intervention started 1 hour before the start of surgery and continued or ≥ 30 minutes following completion of the procedure. Group 2 (n = 25): women received no compression treatment during the surgery and were placed on bed rest beginning 1 hour before the start of surgery. |
|
Outcomes |
Review outcomes reported: symptomatic thromboembolic events; symptomatic PE; symptomatic DVT; blood transfusion; bleeding: estimated blood loss at birth (mL). Other outcomes reported: gestational age; birthweight; 5‐minute Apgar score; operative time; estimated blood loss; use of regional anaesthesia; serum markers of fibrinolysis (tPA, uPA, TAT complex, PAI‐1, PAI‐2). |
|
Notes | Funding sources: Quote: "This study was funded by Charles B. Hammond Research Fund, Duke University School of Medicine, Durham, NC, and DJO, LLC, Vista, CA." "The authors thank DJO, LLC (Vista, CA) for providing equipment to complete the study." Declarations of interest: "None of the authors reports conflict." |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "computer‐generated randomization sequence." |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not feasible due to nature of intervention. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 50 women randomised, 25 to each group; 1 woman randomised to intervention group withdrew, and thus 24 and 25 women analysed in intervention and control groups, respectively. |
Selective reporting (reporting bias) | Unclear risk | No trial protocol to confidently assess selective reporting. |
Other bias | Low risk | No other obvious risk of bias identified. |