Study of Nicotine Patch in Pregnancy (SNIPP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00507975
First received: July 25, 2007
Last updated: December 12, 2012
Last verified: July 2007
  Purpose

There are no established evidences as to the effectiveness in smoking pregnant women of nicotine patches in increasing birth weight, smoking abstinence during pregnancy and concerning the safety their for the fetus/newborn. Moreover, recent studies have shown that the metabolism of nicotine is speeded up in pregnant women suggesting that dose adaptation may be necessary in this population. The main aim of this study is to assess the effectiveness of nicotine patch comparatively to a placebo patch in pregnant women on birth weight and maternal smoking abstinence. The main secondary objective is the assessment of safety of these treatments for the fetus/newborn and for the mother.


Condition Intervention Phase
Smoking
Drug: nicotine versus placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of the Effectiveness of Nicotine Replacement Therapies (Nicotine Patches Delivering Nicotine 16 h/24 h) in 400 Pregnant Smokers. Randomized, Placebo-controlled, Multicenter, National Study. The SNIPP.

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Continuous and complete smoking abstinence of the pregnant women from the first administration of nicotine/placebo patch until delivery. [ Time Frame: from the first administration of nicotine/placebo patch until delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All adverse events occurring during pregnancy [ Time Frame: during pregnancy ] [ Designated as safety issue: Yes ]
  • Point prevalence (7-days) smoking abstinence [ Time Frame: 7-days smoking abstinence ] [ Designated as safety issue: No ]
  • Vital signs of the mother and her body weight [ Time Frame: during pregnancy ] [ Designated as safety issue: Yes ]
  • Echography results of the foetus [ Time Frame: during the pregnancy ] [ Designated as safety issue: Yes ]
  • Birth characteristics of the newborn (Apgar, head circumference, height) [ Time Frame: at the delivery ] [ Designated as safety issue: Yes ]
  • Compliance with treatment [ Time Frame: during the study ] [ Designated as safety issue: Yes ]

Enrollment: 404
Study Start Date: November 2007
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A
The main aim of this study is to assess the effectiveness of nicotine patch comparatively to a placebo patch in pregnant women on birth weight and maternal smoking abstinence. The main secondary objective is the assessment of safety of these treatments for the fetus/newborn and for the mother.
Drug: nicotine versus placebo
The main aim of this study is to assess the effectiveness of nicotine patch comparatively to a placebo patch in pregnant women on birth weight and maternal smoking abstinence. The main secondary objective is the assessment of safety of these treatments for the fetus/newborn and for the mother.
Other Name: nicotine versus placebo
Experimental: B
The main aim of this study is to assess the effectiveness of nicotine patch comparatively to a placebo patch in pregnant women on birth weight and maternal smoking abstinence. The main secondary objective is the assessment of safety of these treatments for the fetus/newborn and for the mother.
Drug: nicotine versus placebo
The main aim of this study is to assess the effectiveness of nicotine patch comparatively to a placebo patch in pregnant women on birth weight and maternal smoking abstinence. The main secondary objective is the assessment of safety of these treatments for the fetus/newborn and for the mother.
Other Name: nicotine versus placebo

Detailed Description:

Smoking during pregnancy is one of the main causes of low birth weight and several disorders during pregnancy involving the mother, the fetus/newborn or both. Only one previous study assessed the efficacy of 16 hours nicotine patch proposed for 3 months in pregnant women for smoking cessation. This study seemed to be underpowered and the compliance was very poor. However, some benefit on birth weight was observed.

The aim of the present study is to demonstrate whether nicotine replacement therapy with 16 h nicotine patch every day increases or not birth weight and abstinence during pregnancy in smoking women. Secondarily, it is aimed to provide descriptive information about the safety of nicotine patches in pregnant women.

This is a double blind, randomized, placebo controlled study. With 200 pregnant women in each arm it will have sufficient power to conclude about differences in birth weight and maternal abstinence between nicotine and placebo.

Women are recruited by health care professionals and directed to the obstetrical departments having previously been agreed to participate in the study.

After a grace period of one month without pharmacological treatment, the pregnant women are randomized into the placebo (N=200) or the nicotine group (N=200). Treatment duration is from randomization till delivery meaning a maximum length of drug/placebo exposure of 6 month during pregnancy. No treatment is started earlier than 3 months' pregnancy. Women may optionally continue their treatment for at least up to 2 months after birth.

At the inclusion visit when the women are smoking, saliva cotinine is collected and determined. The first dose of nicotine is adapted according to the saliva cotinine when smoking to obtain approximately 100 % substitution. A second saliva cotinine determination is realized 2 weeks later and at the next visit nicotine's daily dose is determined according to this second saliva cotinine results for the whole duration of pregnancy. This dose-adaptation is necessary to avoid as far as possible under- and overdosing of nicotine.

The women undergo monthly visits as it is usual and recommended in France. They are followed as well as their newborn up to 2 months after birth.

During the visits standard obstetrical information along with smoking related information and the routinely realized echography data are recorded and birth characteristics collected.

In a subgroup of pregnant women having given their written informed consent and undergoing an amniocentesis for medical reasons, nicotine and cotinine in amniotic fluid will be determined.

In a subgroup of pregnant women having given their written informed consent and breast feeding their baby during the 2 months period after birth, nicotine and cotinine in maternal milk are determined.

There are 2 main outcome comparisons between the nicotine patch and the placebo patch groups: birth weight and maternal continuous, complete abstinence during pregnancy

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • smoking pregnant woman unable to quit smoking during the first 3 months of pregnancy
  • smoking ≥ 5 cigaret/day despite standard medical advice and cognitive-behavioral counselling
  • aged ≥ 18 years
  • health insured
  • motivated to stop smoking; motivation score ≥ 5 on a scale ranging from 0 to 10
  • amenorrhea of 9 to 20 weeks
  • having signed the written informed consent

Exclusion Criteria:

  • non-pregnant women
  • men

Pregnant woman:

  • who does not agree to use a nicotine or placebo patch
  • with presence of chronic psychiatric comorbidity treated continuously by antidepressant, neuroleptic or anxiolytic
  • with skin disorder contraindicating the use of a transdermal patch
  • with known hypersensitivity to transdermal patch or to one of its constituents
  • using other nicotine containing pharmaceutical products (gum, lozenge, inhaler, sublingual tablets)
  • using other forms of tobacco than cigaret (cigaret, pipe or any form of smokeless tobacco)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00507975

Locations
France
Hopital La Pitie Salpetriere
Paris, France, 75013
Groupe Hospitalier Pitié-Salpétrière, Unité de Recherche Clinique
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Ivan BERLIN, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00507975     History of Changes
Other Study ID Numbers: P060604
Study First Received: July 25, 2007
Last Updated: December 12, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Smoking
pregnancy
newborn
birth weight
nicotine patch
birth

Additional relevant MeSH terms:
Smoking
Habits
Nicotine
Nicotine polacrilex
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
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014