Freezie Remedy to Alleviate Morning Sickness

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by The Hospital for Sick Children
Sponsor:
Information provided by (Responsible Party):
Gideon Koren, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01668940
First received: August 16, 2012
Last updated: November 19, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Morning Sickness
Other: Lillipops Iced Soothies (4 flavours)
Other: Mr. Freeze Freezies
Other: Lillipop Iced Soothies (Ginger flavour)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Effectiveness of a Natural Non-medicinal Freezie Remedy to Alleviate Morning Sickness

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Improvement of Nausea and Vomiting of Pregnancy (NVP) [ Time Frame: Baseline, +1, +3, +5, +7 days ] [ Designated as safety issue: No ]
    To assess the effectiveness of Lillipops in the improvement of NVP symptoms. The primary endpoint of interest is the severity of NVP as compared between the 4 groups, defined according to the PUQE-24 (pregnancy-unique quantification of emesis and nausea) scoring system for nausea and vomiting of pregnancy that was developed and validated by Motherisk.


Secondary Outcome Measures:
  • Concurrent Symptoms [ Time Frame: Baseline, +1, +3, +5, +7 days ] [ Designated as safety issue: No ]
    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). The secondary endpoint of interest is the effect of the 4 groups on the status of concurrent symptoms that may intensify NVP, such as metallic taste or gastroesophageal reflux disease, as well as preference for freezie flavours, according to the PUQE-24 (pregnancy-unique quantification of emesis and nausea) scoring system for nausea and vomiting of pregnancy that was developed and validated by Motherisk.

  • Freezie Flavour Preference [ Time Frame: Baseline, +1, +3, +5, +7 days ] [ Designated as safety issue: No ]
    To assess preference for freezie flavours.


Estimated Enrollment: 180
Study Start Date: August 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lillipops Iced Soothies (4 flavours)

Initially, women will be given 1 multiflavour box of Lillipop samples minus the ginger flavour (4 flavours). Each box contains 24 freezies (20 mL each), 6 of each flavor. They will be told to eat the freezies as needed to alleviate symptoms, up to a maximum of 12 per day, and to not have any other popsicles, freezies or any ginger products throughout the duration of the study (7 days). They can request an additional multiflavour box of freezies at each follow-up, as needed.

All participants will initially receive counselling and advice by the Motherisk NVP Counsellor about symptom management. This includes advice about dietary, non-medicinal and medical treatments as per the Motherisk NVP protocol

Other: Lillipops Iced Soothies (4 flavours)
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 were 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.
Experimental: Lillipop Iced Soothies (Ginger flavour)
Initially, women will be given 1 Ginger flavor box of Lillipop samples. Each box contains 24 freezies (20 mL each). Each 20ml contains 80mg of dried ginger root. They will be told to eat the freezies as needed to alleviate symptoms, up to a maximum of 12 a day and to not have any other popsicles, freezies or other ginger products throughout the duration of the study (7 days). Due ginger's antiemetic property, a maximum daily dose is up to 1000mg/day of dried ginger root powder in pregnancy.They can request an additional box of freezies at each follow-up, as needed.All participants will initially receive counselling and advice by the Motherisk NVP Counsellor about symptom management. This includes advice about dietary, non-medicinal and medical treatments as per the Motherisk NVP protocol.
Other: Lillipop Iced Soothies (Ginger flavour)
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 were 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.
Active Comparator: Mr. Freeze Freezies (4 flavours)

Initially, women will be given 1 multiflavour box of Mr. Freeze samples. Each box contains 24 freezies (20 mL each), 6 of each flavor. They will be told to eat the freezies as needed to alleviate symptoms, up to a maximum of 12 per day, and to not have any other popsicles, freezies or any ginger products throughout the duration of the study (7 days). They can request an additional multiflavour box of freezies at each follow-up, as needed.

All participants will initially receive counselling and advice by the Motherisk NVP Counsellor about symptom management. This includes advice about dietary, non-medicinal and medical treatments as per the Motherisk NVP protocol

Other: Mr. Freeze Freezies
There are other commercially available freezies, such as Mr. Freeze. Mr. Freeze freezies contain simulated flavours of watermelon, cherry, blue raspberry and cream soda. However, there have been no reports, studies or claims that they are effective as a remedy for the treatment of NVP.
No Intervention: Natural Course Group

Women will not receive any freezies and will be asked to not have any other popsicles, freezies or any ginger products throughout the duration of the study (7 days).

All participants will initially receive counselling and advice by the Motherisk NVP Counsellor about symptom management. This includes advice about dietary, non-medicinal and medical treatments as per the Motherisk NVP protocol


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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  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: NCT01668940

Contacts
Contact: Gideon Koren, MD (416)813-5778 gkoren@sickkids.ca
Contact: Caroline Maltepe (416) 813 7809 caroline.maltepe@sickkids.ca

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Gideon Koren, MD    416-813-5778    gkoren@sickkids.ca   
Contact: Caroline Maltepe    416-813-7809    caroline.maltepe@sickkids.ca   
Principal Investigator: Gideon Koren, MD         
Sub-Investigator: Caroline Maltepe         
Sub-Investigator: Kamelia Mirdamadi         
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, Director of Motherisk Program, Clinical Pharmacology and Toxicology, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01668940     History of Changes
Other Study ID Numbers: 1000031589
Study First Received: August 16, 2012
Last Updated: November 19, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
Morning Sickness
Lillipops Iced Soothies
Pregnancy
Obstetrics

Additional relevant MeSH terms:
Morning Sickness
Pregnancy Complications
Signs and Symptoms
Signs and Symptoms, Digestive
Vomiting

ClinicalTrials.gov processed this record on June 29, 2015