Morning Sickness
Conditions
Keywords
Morning Sickness, Lillipops Iced Soothies, Pregnancy, Obstetrics
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.
Interventions
OTHERLillipops 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.
OTHERMr. 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.
OTHERLillipop 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.
Sponsors
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes 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.
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of Nausea and Vomiting of Pregnancy (NVP) | Baseline, +1, +3, +5, +7 days | 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
| Measure | Time frame | Description |
|---|---|---|
| Concurrent Symptoms | Baseline, +1, +3, +5, +7 days | 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 | Baseline, +1, +3, +5, +7 days | To assess preference for freezie flavours. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 17 |
| 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. | 14 |
| 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 | 9 |
| 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 | 14 |
| Total | 54 |
Baseline characteristics
| Characteristic | Lillipop Iced Soothies (Ginger Flavour) (Experimental) | Mr. Freeze Freezies (4 Flavours) (Active Comparator) | Lillipops Iced Soothies (4 Flavours) (Experimental) | Natural Course Group (No Intervention) | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 9 Participants | 17 Participants | 14 Participants | 54 Participants |
| Age, Continuous | 33.9 years | 33.6 years | 31 years | 31.8 years | 32.4 years |
| Region of Enrollment Canada | 14 participants | 9 participants | 17 participants | 14 participants | 54 participants |
| Sex: Female, Male Female | 14 Participants | 9 Participants | 17 Participants | 14 Participants | 54 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 14 | 0 / 9 | 0 / 14 |
| serious Total, serious adverse events | 0 / 17 | 0 / 14 | 0 / 9 | 0 / 14 |
Outcome results
Primary
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.
Time frame: Baseline, +1, +3, +5, +7 days
Population: The study was terminated due to the original study PI's departure, and the final analyses have not been conducted. The study file has been locked in 2015 after the official study closure.
Secondary
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.
Time frame: Baseline, +1, +3, +5, +7 days
Secondary
Freezie Flavour Preference
To assess preference for freezie flavours.
Time frame: Baseline, +1, +3, +5, +7 days