Ambulatory fetal movement monitoring device - Fetal Kicks

This trial is for pregnant women who have normal, uncomplicated pregnancies. Patients will be asked if they wish to participate. They will have the trial explained to them and told that their participation is completely voluntary, they will be reassured that inclusion or not, will have no effect on their medical treatment at any time. Nor will it have any effect on the relationship they have with the hospital staff. As the study relates to fetal movement, no tissue is collected. Participants will be told that they are free to withdraw at any time, and they do not need to provide a reason for withdrawing from the study. If the participant has expressed an interest, she will be given the patient information and made aware there will be no financial incentive for participation. This is a once-off trial, where the patient will undergo overnight monitoring using the Fetal Kicks device from 10pm to 8am. The device that will be used in this trial is named the Fetal Kicks device. The Fetal Kicks device is an easy to use, wearable, wireless monitoring device for pregnant woman who present reduced fetal movement. The overall feel of the device doesn’t differ much from a normal bandaid. This Fetal Kicks device has a flexible electronic circuit board layer and encapsulated with sweat permeable sports bandage. Underneath the device there is a layer of disposable one-use double-sided medical 3M silicone adhesive. The device is approximately 75mm long, 28mm wide and 2mm. If participants opt to participate in the trial, they will take the device home to use before bed. The midwife will scan the participant’s abdomen using a handheld ultrasound in a semi-recumbent position for up to 10 minutes to identify the fetus's presentation. After that, the participant will be taught by the study coordinator or midwives to attach the soft Fetal Kicks device(s) to her belly. In short, the protective backing of the adhesive underneath the Fetal Kicks device is peeled off, and it is attached to the prescribed spot on the pregnant woman’s stomach. The soft Fetal Kicks device(s) will be attached to the belly by the participant at home, preferably before 10 pm. After that, the participant will be required to perform activities below: > Lifting up an object from floor to knee height for 5 times > Twisting your body left and right for 5 times each > Bending down for 5 times > Standing for 2 minutes > Walking for 2 minutes > Lying down for 2 minutes > Sitting for 2 minutes Following this, the participant will need to continue wearing the device until the next morning when she’s awake preferably after 8 am. The participant can remove the soft Fetal Kicks device(s) when she’s awake. After this study, the participant will have to return the device(s) to the study coordinator / midwives, and a form will be given to her to evaluate her experience with the study process and to provide feedback on the device as well as the aspects which could be improved upon and raise any safety concerns she might have had during the monitoring process If at any time during the study a participant becomes upset or distressed, they will be encouraged to contact the study coordinator immediately. The research will stop and counselling or other appropriate support will be arranged by the study doctor.