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Freezie Remedy to Alleviate Morning Sickness

Primary Purpose

Morning Sickness

Status

Terminated

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Lillipops Iced Soothies (4 flavours)

Mr. Freeze Freezies

Lillipop Iced Soothies (Ginger flavour)

About this trial

This is an interventional treatment trial for Morning Sickness focused on measuring Morning Sickness, Lillipops Iced Soothies, Pregnancy, Obstetrics

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Lillipops Iced Soothies (4 flavours)

Lillipop Iced Soothies (Ginger flavour)

Mr. Freeze Freezies (4 flavours)

Natural Course Group

Arm Description

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

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.

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

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

Outcomes

Primary Outcome Measures

Improvement of Nausea and Vomiting of Pregnancy (NVP)

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

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

To assess preference for freezie flavours.

Full Information

NCT ID

NCT01668940

First Posted

August 16, 2012

Last Updated

January 6, 2020

Sponsor

The Hospital for Sick Children

1. Study Identification

Unique Protocol Identification Number

NCT01668940

Brief Title

Freezie Remedy to Alleviate Morning Sickness

Official Title

Effectiveness of a Natural Non-medicinal Freezie Remedy to Alleviate Morning Sickness

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Terminated

Why Stopped

The study PI left the institution in early 2015.

Study Start Date

August 2012 (Actual)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Hospital for Sick Children

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Morning Sickness

Keywords

Morning Sickness, Lillipops Iced Soothies, Pregnancy, Obstetrics

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

A computerized randomization table will be prepared by a third party who is not otherwise involved in the study. After a participant has given consent to enrol in the study, the next participant number in sequence will be assigned and the appropriate corresponding sealed envelope will be opened by the study coordinator, determining which product (if any) the participant will receive. The boxes will be given unique codes depending on whether they contain Lillipops (4 flavours), Ginger Lillipops or Mr. Freeze freezies, and the different flavours will also be coded. Participants will be shown a list of the ingredients that are found in Lillipops and Mr. Freeze freezies to ensure that they do not have allergies or take medications that interact with any ingredient(s) that they may be asked to consume.

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lillipops Iced Soothies (4 flavours)

Arm Type

Experimental

Arm Description

Arm Title

Lillipop Iced Soothies (Ginger flavour)

Arm Type

Experimental

Arm Description

Arm Title

Mr. Freeze Freezies (4 flavours)

Arm Type

Active Comparator

Arm Description

Arm Title

Natural Course Group

Arm Type

No Intervention

Arm Description

Intervention Type

Other

Intervention Name(s)

Lillipops Iced Soothies (4 flavours)

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Mr. Freeze Freezies

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Lillipop Iced Soothies (Ginger flavour)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Improvement of Nausea and Vomiting of Pregnancy (NVP)

Description

Time Frame

Baseline, +1, +3, +5, +7 days

Secondary Outcome Measure Information:

Title

Concurrent Symptoms

Description

Time Frame

Baseline, +1, +3, +5, +7 days

Title

Freezie Flavour Preference

Description

To assess preference for freezie flavours.

Time Frame

Baseline, +1, +3, +5, +7 days

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shinya Ito, MD

Organizational Affiliation

The Hospital for Sick Children

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Hospital for Sick Children

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1X8

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

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Freezie Remedy to Alleviate Morning Sickness

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