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Sleep in Pregnancy Pilot Trial

SliPP: A multi centre randomised trial assessing time spent in supine position during sleep in the third trimester of pregnancy with or without a position aid.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001462279
Acronym
SliPP
Enrollment
332
Registered
2018-08-30
Start date
2018-09-10
Completion date
2020-08-28
Last updated
2018-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This trial will test whether advice alone compared to advice and a pillow device best supports non-supine sleep using the Night Shift as an objective measure of both sleep duration and position. This design could also be employed in the future for a roll out of sleep position interventions, but crucially the optimum intervention would need to be properly validated, which is what this trial aims to do.

Interventions

All women attending for their routine antenatal appointment will be approached and informed about the study by a midwife or a member of the research team. Women will be given a brochure already being used as part of an Australian public health campaign about sleep position in pregnancy. The brochure is freely available in paper form and on the internet. All women participating in the study will be given a NightShift device to wear for 7 consecutive nights between 28-30 weeks and 36-38 weeks. The

All women attending for their routine antenatal appointment will be approached and informed about the study by a midwife or a member of the research team. Women will be given a brochure already being used as part of an Australian public health campaign about sleep position in pregnancy. The brochure is freely available in paper form and on the internet. All women participating in the study will be given a NightShift device to wear for 7 consecutive nights between 28-30 weeks and 36-38 weeks. They will be asked to return the device to the research team between the two time points for data collection. Women in the intervention group will also be given a U shaped pillow slip, which were designed and made in NZ by a midwife. The pillow slip can be purchased online and is marketed for pregnant women to assist more comfortable sleeping in pregnancy.

Sponsors

Royal Prince Alfred Hosital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Women with a singleton pregnancy, >28 weeks gestation.

Exclusion criteria

Multiple pregnancy, inability to side sleep (e.g. existing conditions), known major congenital abnormality of the fetus, women <18yrs.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026