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Study of Nicotine Replacement Therapy in Pregnancy

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ClinicalTrials.gov Identifier: NCT00744913
Recruitment Status : Withdrawn (Discontinued due to difficulty in recruitment)
First Posted : September 1, 2008
Last Update Posted : August 15, 2013
Sponsor:
Information provided by (Responsible Party):
Gideon Koren, The Hospital for Sick Children

Brief Summary:
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 or disease Intervention/treatment Phase
Smoking Cessation Drug: Nicoderm patches Other: Counselling Phase 3

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  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Controlled Open-Label Study of Nicotine Replacement Therapy in Pregnancy
Study Start Date : August 2008
Estimated Primary Completion Date : February 2010
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Quitting Smoking
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00744913


Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Gideon Koren, MD The Hospital for Sick Children

Responsible Party: Gideon Koren, Director of MotherRisk Program, Clinical Pharmacology and Toxicology, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00744913     History of Changes
Other Study ID Numbers: 1000010740
First Posted: September 1, 2008    Key Record Dates
Last Update Posted: August 15, 2013
Last Verified: August 2013

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

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