Clinical trial NCT01668940: Freezie Remedy to Alleviate Morning Sickness
Official title: Effectiveness of a Natural Non-medicinal Freezie Remedy to Alleviate Morning Sickness
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Morning Sickness
Keywords: Morning Sickness
Lillipops Iced Soothies
Pregnancy
Obstetrics
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2012-08-20
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Four parallel groups: 1) Lillipops Group (4 flavours): 2) Ginger Lillipops Group; 3) Mr. Freeze Control Group; 4) Natural Course Group. The main comparison is Group 1 vs Group 3.
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the effectiveness of Lillipops in the improvement of morning sickness symptoms. Secondary objectives are to assess if there are any changes to concurrent symptoms that may intensify NVP, such as metallic taste or gastrointestinal issues (e.g. heartburn, acid reflux, indigestion and gas), as well as preference for freezie flavours.

Detailed description: Nausea and vomiting of pregnancy (NVP) is the most common medical condition of pregnancy, also known as morning sickness which affects up to 80% of pregnant women. Lillipops Iced Soothies are naturally flavoured freezies developed in the United Kingdom for women with morning sickness. They are available in 5 different flavours: grapefruit and tangerine, lemon and mint, chamomile and orange, lime and vanilla, and ginger. The flavours are derived from steam distillation of the peels (grapefruit, tangerine, lemon, orange, lime), mint leaves, and chamomile flowers to release and collect their essential oils. Vanilla pods and ginger are macerated and their resin is used. These flavours are chosen because they may provide relief of symptoms as they are either traditional remedies for NVP, such as ginger, or soothing and refreshing flavours, such as chamomile, vanilla and citrus.

This study hypothesizes that using Lillipops Iced Soothies will reduce the severity of NVP symptoms according to the PUQE-24 (pregnancy-unique quantification of emesis and nausea) scoring system for nausea and vomiting of pregnancy. In addition, we hypothesize concurrent symptoms that may intensify NVP, such as metallic taste or gastrointestinal disorders (e.g. heartburn, acid reflux, indigestion and gas), will be alleviated. We hypothesize that improvements to NVP and concurrent symptoms will be greater with Lillipop freezies compared to another commercially available freezie.

Eligibility criteria: Inclusion Criteria:

* Pregnancy between 4 and 12 weeks gestation.
* Pregnant women with NVP, regardless of treatment (if any) for their NVP.
* Provide the signed informed consent form prior to initial interview.
* Able to come in person to Sick Kids or meet at an agreed location.

Exclusion Criteria:

* Gestational age beyond 12 weeks of pregnancy.
* Pregnant women less than 18 years of age.
* Women who are not proficient in the English language.
* Unable to consume any of the ingredients listed in Lillipops or Mr. Freeze freezies due to allergies, medication interactions or other reasons.
* Women refusing to avoid sources of ginger products for the duration of the study.

Primary outcomes:
measure: Improvement of Nausea and Vomiting of Pregnancy (NVP)
timeFrame: Baseline, +1, +3, +5, +7 days
Secondary outcomes:
measure: Concurrent Symptoms
timeFrame: Baseline, +1, +3, +5, +7 days
measure: Freezie Flavour Preference
timeFrame: Baseline, +1, +3, +5, +7 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Shinya Ito, MD
role: PRINCIPAL_INVESTIGATOR
References: