Study of Nicotine Replacement Therapy in Pregnancy

The Hospital for Sick Children

Status and phase

Withdrawn

Phase 3

Conditions

Smoking Cessation

Treatments

Drug: Nicoderm patches

Other: Counselling

Study type

Interventional

Funder types

Other

Identifiers

NCT00744913

1000010740

Details and patient eligibility

About

The overall objective of this study is to assess the effectiveness of NRT (Nicoderm patches) plus counselling treatment in women in the second and third trimester of pregnancy.

Full description

Smoking during pregnancy is a major public health issue, causing miscarriages, prematurity, intrauterine growth retardation, stillbirth, and the Sudden Infant Death Syndrome (SIDS). It is estimated that 25-40% of pregnant smokers try to stop smoking on their own upon learning that they are pregnant. While pregnancy is often a strong motivator for smoking cessation, many nicotine-dependent women cannot quit smoking. The most important factor underlying the inability to quit smoking is strong dependence on a certain level nicotine, which is unique in every individual.

Several publications have shown that the use of the nicotine patch during the second and third trimesters is not associated with maternal or fetal compromise. More importantly, nicotine replacement therapy (NRT) during pregnancy exposes the fetus to lower levels of nicotine than smoking cigarettes does and, moreover, eliminates exposure to numerous other toxic substances.

Presently, counselling is the standard mode of treatment for the pregnant patients willing to quit smoking. Since pharmacologic smoking cessation therapies have been shown to increase significantly up to doubling a successful quitting rate when used in adjunction to brief physician counselling, the use of an appropriate dose of such agents is essential.

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Women who smoke
Pregnant women after 12 weeks gestation, confirmed by ultrasound
On the day of the recruitment, women will be at least 18 years old and no older than 40 years old
Agree to sign consent form and participate in all aspects of the follow-up

Exclusion criteria

Women who refuse to participate in the study/sign a written consent
Women with insufficient English language skills to understand the questionnaires and assessment material
Women with multiple pregnancy
Women with confirmed cardiac pathology
Women who receive concurrent treatment with Bupropion
Congenital malformations visualized by ultrasound
Objection from the physician caring for the woman to her participation