Study of Nicotine Replacement Therapy in Pregnancy

August 14, 2013 updated by: Gideon Koren, The Hospital for Sick Children

Randomized, Controlled Open-Label Study of Nicotine Replacement Therapy in Pregnancy

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: 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
Active Comparator: 2
Other: Counselling
Women in this arm of the study will receive standard counseling only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the effectiveness of NRT (Nicoderm patches) at doses of 14 mg/day or 21 mg/day plus counselling treatment
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare the effectiveness of counseling and NRT at doses of 14 mg/day or 21 mg/day with counselling alone.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Investigators

  • Principal Investigator: Gideon Koren, MD, The Hospital for Sick Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Anticipated)

February 1, 2010

Study Completion (Anticipated)

March 1, 2010

Study Registration Dates

First Submitted

August 29, 2008

First Submitted That Met QC Criteria

August 29, 2008

First Posted (Estimate)

September 1, 2008

Study Record Updates

Last Update Posted (Estimate)

August 15, 2013

Last Update Submitted That Met QC Criteria

August 14, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000010740

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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