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Study of Nicotine Replacement Therapy in Pregnancy

NCT ID: NCT00744913

Last Updated: 2013-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Smoking Cessation

Keywords

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Pregnancy Women Nicotine replacement therapy Smoking cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Nicoderm patches

Intervention Type DRUG

Women in this group will receive standard counselling and NRT (Nicoderm patches) starting with a dose of 14 mg/day that can be increased to 21 mg/day based on response (smoking cessation) and potential side effects

2

Group Type ACTIVE_COMPARATOR

Counselling

Intervention Type OTHER

Women in this arm of the study will receive standard counseling only.

Interventions

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Nicoderm patches

Women in this group will receive standard counselling and NRT (Nicoderm patches) starting with a dose of 14 mg/day that can be increased to 21 mg/day based on response (smoking cessation) and potential side effects

Intervention Type DRUG

Counselling

Women in this arm of the study will receive standard counseling only.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Gideon Koren

Director of MotherRisk Program, Clinical Pharmacology and Toxicology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gideon Koren, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Countries

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Canada

Other Identifiers

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1000010740

Identifier Type: -

Identifier Source: org_study_id