abstinence from the date of smoking cessation until delivery
Design
Two arm parallel group randomized trial,double - blind , placebo- controlled to assess nicotine - replacement patches for prolonged abstinence from smoking during pregnancy
Settings and conduct
Midwives researches study enrollment of women who agreed with the quit in two weeks. Subjects randomly received 4 weeks of patches of skin (containing 15 mg of nicotine every 16 hours) in place of placebo for delivery to mothers and one month after the start of the study, salivary cotinin test was taken from mothers who said they did not smoke. When less than 8 ppm, nicotine patches were given to moms for another 4 weeks.The patches of the placebo group are very similar to nicotine patches.
Participants/Inclusion and exclusion criteria
inclusion criteria : women who agreed to set a quit date , 16 to 50 years of age , 12 to 24 weeks of gestation , smoked 10 or more cigarettes daily before pregnancy, currently smoked 5 or more cigarettes daily
exclusion criteria : known major fetal abnormalities , inability to provide informed consent , chemical or alcohol dependence , chronic generalized skin disorders
Intervention groups
pregnancies of 12 -24 to weeks gestation
Main outcome variables
abstinence from the date of smoking cessation until delivery - out comes for the fetus and baby: miscarriage , stillbirth , neonatal death , congenital abnormality , neonatal convulsion ,birth weight
General information
Reason for update
Acronym
NRT
IRCT registration information
IRCT registration number:IRCT20181209041904N1
Registration date:2018-12-21, 1397/09/30
Registration timing:prospective
Last update:2018-12-21, 1397/09/30
Update count:0
Registration date
2018-12-21, 1397/09/30
Registrant information
Name
zohre gozidehkar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3258 3449
Email address
zohre.gozidehkar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-26, 1398/01/06
Expected recruitment end date
2022-03-26, 1401/01/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of treatment with nicotine patches versus support behavior in smoking cessation in pregnant women
Public title
Nicotine-Replacement Therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 16-50 years
12-24 weeks of pregnancy
Smoking is 10 or more cigarettes a day before pregnancy
Daily smoking of 5 yarns during the current pregnancy
Exclusion criteria:
Maternal mothers who have been diagnosed with ultrasound diagnosis of fetal abnormalities.
Pregnant women who are allergic to chemicals or alcohol
Pregnant mothers with generalized skin diseases
Pregnancy mothers who are allergic to nicotine patches
Age
From 16 years old to 50 years old
Gender
Female
Phase
0
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
1050
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Individual randomization unit
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and midwives have been blinded to study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethinics commitee of zahedan university of medical sciences
Street address
dr hesabi aveniu
City
zhedan
Province
Sistan-va-Balouchestan
Postal code
9769144155
Approval date
2018-11-12, 1397/08/21
Ethics committee reference number
354554
Health conditions studied
1
Description of health condition studied
Addiction in pregnancy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
self-reported abstinence from smoking between the quit date and child-birth
Timepoint
Before the intervention, 4 weeks after the intervention, 8 weeks after the intervention, the delivery time
Method of measurement
Perform salivary catechin test and CO respiration test