Freezie Remedy to Alleviate Morning Sickness

NCT01668940 | Terminated Results DMC

• 1 other identifier: 1000031589
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Morning Sickness

Keywords

Morning Sickness; Lillipops Iced Soothies; Pregnancy; Obstetrics

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (2)

• Concurrent Symptoms

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

• Freezie Flavour Preference

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

Study Arms (4)

Lillipops Iced Soothies (4 flavours)

EXPERIMENTAL

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)

Lillipop Iced Soothies (Ginger flavour)

EXPERIMENTAL

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)

Mr. Freeze Freezies (4 flavours)

ACTIVE COMPARATOR

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

Natural Course Group

NO INTERVENTION

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

Interventions

Lillipops Iced Soothies (4 flavours) OTHER

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.

Lillipops Iced Soothies (4 flavours)

Mr. Freeze Freezies OTHER

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.

Mr. Freeze Freezies (4 flavours)

Lillipop Iced Soothies (Ginger flavour) OTHER

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.

Lillipop Iced Soothies (Ginger flavour)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Morning Sickness

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vomiting; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Study was terminated prior to completion. Data collected from participants was not analyzed.

Results Point of Contact

• Title: Dr Shinya Ito, Principal Investigator
• Organization: The Hospital for Sick Children

shinya.ito@sickkids.ca

4168135776

Study Officials

• Shinya Ito, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Head, Clinical Pharmacology and Toxicology

Model Details: 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.

Study Record Dates

• First Submitted: August 16, 2012
• First Posted: August 20, 2012
• Study Start: August 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: January 10, 2020
• Results First Posted: January 10, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)