Skip to main content
. 2018 May 31;2018(5):CD000146. doi: 10.1002/14651858.CD000146.pub5

El‐Mohandes 2013.

Methods Country: USA
Recruitment: healthcare (3 prenatal care sites)
Participants 52 pregnant (< 30 weeks gestation) smokers motivated to quit, self‐identified as ethnic minority
100% female, average age 28, average cpd 6, mean gestational age at baseline 9 weeks
Interventions 1. Nicotine patch, 10 weeks. Dose based on baseline salivary cotinine: if baseline salivary cotinine level ≥ 100 ng/ml then 21 mg patches for 2 weeks, 14 mg patches for 4 weeks and 7 mg patches for 4 weeks. If baseline salivary cotinine level 20 to 99 ng/ml then 14 mg patches for 6 weeks and 7 mg patches for 4 weeks
2. No pharmacotherapy
Level of support: high (6 individual in person counselling visits)
Outcomes Abstinence since last visit (approximately 3 weeks) at 20 weeks
Validation: CO ≤ 8 ppm
Notes New for 2017 update
Does not contribute to primary analyses as follow‐up < 6 months. 20‐week abstinence (pre‐delivery) included in Analysis 5.1.1
Funding: Eunice Kennedy Shriver National Institute of Child Health and Human Development
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: “Using a 1:1 ratio, women were randomized to either the NRT patch and continued CBT (Group 1) or CBT only (Group 2)… The web‐based database management system was programmed to randomize after entering the necessary data to verify eligibility and administration of the baseline survey.”
Allocation concealment (selection bias) Low risk Quote: “The web‐based database management system was programmed to randomize after entering the necessary data to verify eligibility and administration of the baseline survey.”
Blinding (performance bias and detection bias) 
 All outcomes High risk Quote: “Telephone interviewers were blinded to group assignment.” “The intervention specialists were blinded to group assignment.” No placebo
Incomplete outcome data (attrition bias) 
 All outcomes High risk At the strictest quit timepoint (salivary continine levels at final visit), 34/52 participants lacked data (> 50%). If already delivered before 20 week follow‐up, did not have a visit 6 and smoking status not known