Trial Outcomes & Findings for Freezie Remedy to Alleviate Morning Sickness (NCT NCT01668940)
NCT ID: NCT01668940
Last Updated: 2020-01-10
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
54 participants
Primary outcome timeframe
Baseline, +1, +3, +5, +7 days
Results posted on
2020-01-10
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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
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.
|
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
14
|
9
|
14
|
|
Overall Study
COMPLETED
|
17
|
14
|
9
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
All participants female as per study inclusion criteria. No analysis was completed due to study termination/closure.
Baseline characteristics by cohort
| Measure |
Lillipops Iced Soothies (4 Flavours) (Experimental)
n=17 Participants
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
|
Lillipop Iced Soothies (Ginger Flavour) (Experimental)
n=14 Participants
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.
|
Mr. Freeze Freezies (4 Flavours) (Active Comparator)
n=9 Participants
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
|
Natural Course Group (No Intervention)
n=14 Participants
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
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
54 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Continuous
|
31 years
n=99 Participants
|
33.9 years
n=107 Participants
|
33.6 years
n=206 Participants
|
31.8 years
n=7 Participants
|
32.4 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants • All participants female as per study inclusion criteria. No analysis was completed due to study termination/closure.
|
14 Participants
n=107 Participants • All participants female as per study inclusion criteria. No analysis was completed due to study termination/closure.
|
9 Participants
n=206 Participants • All participants female as per study inclusion criteria. No analysis was completed due to study termination/closure.
|
14 Participants
n=7 Participants • All participants female as per study inclusion criteria. No analysis was completed due to study termination/closure.
|
54 Participants
n=31 Participants • All participants female as per study inclusion criteria. No analysis was completed due to study termination/closure.
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants • All participants female as per study inclusion criteria. No analysis was completed due to study termination/closure.
|
0 Participants
n=107 Participants • All participants female as per study inclusion criteria. No analysis was completed due to study termination/closure.
|
0 Participants
n=206 Participants • All participants female as per study inclusion criteria. No analysis was completed due to study termination/closure.
|
0 Participants
n=7 Participants • All participants female as per study inclusion criteria. No analysis was completed due to study termination/closure.
|
0 Participants
n=31 Participants • All participants female as per study inclusion criteria. No analysis was completed due to study termination/closure.
|
|
Region of Enrollment
Canada
|
17 participants
n=99 Participants • All participants recruited in Canada as per study inclusion criteria (i.e. ability to meet at study site or nearby location). No analysis was completed due to study termination/closure.
|
14 participants
n=107 Participants • All participants recruited in Canada as per study inclusion criteria (i.e. ability to meet at study site or nearby location). No analysis was completed due to study termination/closure.
|
9 participants
n=206 Participants • All participants recruited in Canada as per study inclusion criteria (i.e. ability to meet at study site or nearby location). No analysis was completed due to study termination/closure.
|
14 participants
n=7 Participants • All participants recruited in Canada as per study inclusion criteria (i.e. ability to meet at study site or nearby location). No analysis was completed due to study termination/closure.
|
54 participants
n=31 Participants • All participants recruited in Canada as per study inclusion criteria (i.e. ability to meet at study site or nearby location). No analysis was completed due to study termination/closure.
|
PRIMARY outcome
Timeframe: Baseline, +1, +3, +5, +7 daysPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, +1, +3, +5, +7 daysTo 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, +1, +3, +5, +7 daysTo assess preference for freezie flavours.
Outcome measures
Outcome data not reported
Adverse Events
Lillipops Iced Soothies (4 Flavours)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lillipop Iced Soothies (Ginger Flavour)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mr. Freeze Freezies (4 Flavours)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Natural Course Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Shinya Ito, Principal Investigator
The Hospital for Sick Children
Phone: 4168135776
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place