Freezie Remedy to Alleviate Morning Sickness

The Hospital for Sick Children

Status: Terminated

Conditions: Morning Sickness

Treatments: Other: Lillipop Iced Soothies (Ginger flavour); Other: Lillipops Iced Soothies (4 flavours); Other: Mr. Freeze Freezies

Study type: Interventional

Funder types: Other

Identifiers

NCT01668940

1000031589

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 4 patient groups

Lillipops Iced Soothies (4 flavours)

Experimental group

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

Treatment:

Other: Lillipops Iced Soothies (4 flavours)

Lillipop Iced Soothies (Ginger flavour)

Experimental group

Description:

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.

Treatment:

Other: Lillipop Iced Soothies (Ginger flavour)

Mr. Freeze Freezies (4 flavours)

Active Comparator group

Description:

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

Treatment:

Other: Mr. Freeze Freezies

Natural Course Group

No Intervention group

Description:

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