Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Smoking Cessation Intervention During Pregnancy in Argentina and Uruguay
Brief Summary: Argentina and Uruguay are among the countries with the highest proportion of pregnant women who smoke. The implementation of an effective smoking cessation intervention would have a significant impact on the health of mothers and children. The "5 A's" (Ask, Advise, Assess, Assist, Arrange) is a strategy consisting of a brief cessation counseling session of 5-15 minutes delivered by a trained provider, which is considered the standard of care worldwide. However, it is under used in Argentina and Uruguay. We will conduct a two-arm, parallel cluster randomized controlled trial of an implementation intervention in 20 prenatal clinics in Argentina and Uruguay. Our primary hypothesis is that the intervention is feasible in prenatal clinics in Argentina and Uruguay and will increase the frequency of women receiving tobacco use cessation counseling during pregnancy. Our secondary hypothesis is that the intervention will decrease the frequency of women who smoke by the end of their pregnancies. Prenatal clinics will be randomly allocated to either an intervention or a control group after a baseline data collection period. Midwife facilitators in the ten intervention clinics will be identified and trained to deliver the "5 A's" to pregnant women and will then disseminate and implement the program. The ten clinics in the control group will continue with their standard in-service activities. A follow-up data collection will be conducted immediately after delivery. The intervention will be tailored by formative research to be readily applicable to local prenatal care services at busy maternity hospitals, as well as to be acceptable to local pregnant women and health providers. The study will be conducted in 48 months.


Options:
A: Inclusion Criteria por prenatal clinics:

* Not having a smoking cessation program based on the "5 A's" for pregnant women in place.
* An estimated frequency of women receiving the "5 A's" intervention below 20%
* Having midwives or nurse-midwives as part of the hospital or primary health center staff.
* Having signed a letter of intention to participate in the project.
* Having at least 400 new pregnant women per year.

Exclusion Criteria for prenatal clinics:

* None
B: Inclusion Criteria:

* Be at least 18 years of age
* Be between 13 and 25 weeks of pregnancy
* Be receiving prenatal care at one of the participating clinics
* Have smoked at least 100 cigarettes in their lifetime
* Be currently smoking and have smoked at least 5 cigarettes per day in the past 7 days
* Speak and write English

Exclusion Criteria:

* Evidence of cognitive or mental health problems
* Evidence of possible drug or alcohol addiction
* Documented history in medical chart of mental retardation, significant chronic or recurrent psychiatric disorder such as schizophrenia or severe depression, history of cardiac arrhythmias, history of myocardial infarction within the past 6 months, history of previous pregnancy with congenital anomaly,family history of congenital anomalies
* Complications of pregnancy during the current pregnancy, including: threatened miscarriage, congenital anomalies, unexplained vaginal bleeding, pelvic or abdominal surgical procedures, deep venous thrombosis, malignancy
C: Inclusion Criteria:

* Pregnant women
* current cigarette smoker (smoked \>1 cigarette in the past 7 days)
* 18 years old or older
* Willing to consider altering their smoking behavior during their pregnancy

Exclusion Criteria:

* More than 26 weeks' gestation at study entry
* No telephone access
* Not planning to live in New England for 1 year
* Unable to read and speak English
D: Inclusion Criteria:

* Participants are over 16 and will need to agree to i) receive counselling ii) to set a quit within two weeks and iii) consent to follow up processes.

Exclusion Criteria:

* Telephonists will not enrol potential participants who are not capable of giving informed consent or who have not got access to a phone contact number to which calls can be made by Essentia staff.

Answer: A