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Study of Nicotine Replacement Therapy in Pregnancy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by The Hospital for Sick Children.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00744913
First received: August 29, 2008
Last updated: September 10, 2008
Last verified: September 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Smoking Cessation
 Drug: Nicoderm patches
Other: Counselling
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Controlled Open-Label Study of Nicotine Replacement Therapy in Pregnancy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: August 2008
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00744913

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada
Contact: Gideon Koren, MD     (416)813-5778     gideon.koren@sickkids.ca    
Principal Investigator: Gideon Koren, MD            
Sub-Investigator: Alex Kazmin, MD            
Sub-Investigator: Alla Odsadchy, MD            
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Gideon Koren, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Gideon Koren/Principal Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00744913     History of Changes
Other Study ID Numbers: 1000010740
Study First Received: August 29, 2008
Last Updated: September 10, 2008
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
Pregnancy
Women
Nicotine replacement therapy
Smoking cessation

Additional relevant MeSH terms:
Smoking
Habits
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013