Study: NCT04437407

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: PB2-1 prototype
Description: PB2-1 prototype is a belt-like wearable device similar to the original PrenaBelt designed for pregnant women that permits supine positioning of the pelvis but, when in this position, provides subtle pressure points to the user's body and thereby activates the body's natural mechanism to reposition itself to relieve discomfort. It is expected to significantly decrease the amount of time a pregnant woman's pelvis is in the supine position overnight while promoting comfortable sleep.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: PB2-2 prototype
Description: PB2-2 prototype is a belt-like wearable device designed for pregnant women. When placed on the woman's back, this device prevents the pelvis from achieving a supine orientation by maintaining at least fifteen degrees of right or left lateral pelvic tilt. It is expected to significantly decrease the amount of time a pregnant woman's pelvis is in the supine position overnight while promoting comfortable sleep.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: PB2-3 prototype
Description: PB2-3 prototype is a belt-like wearable device designed for pregnant women. When placed on the woman's back, this device prevents the pelvis from achieving a supine orientation by maintaining at least fifteen degrees of right or left lateral pelvic tilt. It is expected to significantly decrease the amount of time a pregnant woman's pelvis is in the supine position overnight while promoting comfortable sleep.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: PB2-4 prototype
Description: PB2-4 prototype is a belt-like wearable device designed for pregnant women that prevents the user from achieving a supine position as the device allows right and left lateral pelvic tilt but prevents the user's pelvis from settling supine due to virtue of its design. It is expected to significantly decrease the amount of time a pregnant woman's pelvis is in the supine position overnight while promoting comfortable sleep.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: PB2-5 prototype
Description: PB2-5 prototype is a belt-like wearable device designed for pregnant women that does not provide positional therapy. It can be worn anytime as a maternity support belt.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Ajuvia-Active
Description: Ajuvia Sleep Monitor senses the user's body position and can be used in passive or active mode with or without the PB2 prototypes. In the active mode, it alerts the woman when her pelvis is in the supine position through a gentle vibratory alarm.

Intervention type: DEVICE
Group type: OTHER
Intervention: Ajuvia-Passive
Description: Ajuvia Sleep Monitor senses the user's body position and can be used in passive or active mode with or without the PB2 prototypes. In the passive mode, it measures and records the position of the pelvis but does not alert the woman.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Ajuvia-Passive
Description: Ajuvia Sleep Monitor senses the user's body position and can be used in passive or active mode with or without the PB2 prototypes. In the passive mode, it measures and records the position of the pelvis but does not alert the woman.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Ajuvia-Passive
Description: Ajuvia Sleep Monitor senses the user's body position and can be used in passive or active mode with or without the PB2 prototypes. In the passive mode, it measures and records the position of the pelvis but does not alert the woman.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Ajuvia-Passive
Description: Ajuvia Sleep Monitor senses the user's body position and can be used in passive or active mode with or without the PB2 prototypes. In the passive mode, it measures and records the position of the pelvis but does not alert the woman.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Ajuvia-Passive
Description: Ajuvia Sleep Monitor senses the user's body position and can be used in passive or active mode with or without the PB2 prototypes. In the passive mode, it measures and records the position of the pelvis but does not alert the woman.