None listed
Conditions
Brief summary
We plan to test a new prototype intrauterine contraceptive device (IUD) inserter designed specifically for postpartum use. The device has been tested in a simulation setting and functions as intended. The device has not been tried in human subjects. The reason for the study is to test that the device functions as intended in actual use. Ten women will be enrolled. They will consent to have an IUD inserted after normal childbirth. A standard IUD that is already in routine clinical use will be inserted, using the new inserter. The location of the IUD will be confirmed by ultrasound at the time of insertion, within 5-10 days of insertion, and at 42-56 days after insertion. The clinician inserting the IUD (a member of the research team), and the woman receiving the IUD will complete brief surveys regarding their experiences with the use if the device.
Interventions
The intervention is the insertion of a post-partum intrauterine device (PPIUD) using a dedicated prototype PPIUD insertion device designed specifically for post-partum use. The intervention will entail having a PPIUD (commercially available device, copper or hormone containing IUD) placed within 10 minutes of placental delivery following vaginal birth. The insertion procedure takes less than 5 minutes and is performed once. The device will be inserted by a trained delivery attendant who is part
The intervention is the insertion of a post-partum intrauterine device (PPIUD) using a dedicated prototype PPIUD insertion device designed specifically for post-partum use. The intervention will entail having a PPIUD (commercially available device, copper or hormone containing IUD) placed within 10 minutes of placental delivery following vaginal birth. The insertion procedure takes less than 5 minutes and is performed once. The device will be inserted by a trained delivery attendant who is part of the research team (senior doctor, midwife or nurse practitioner) using the dedicated prototype device. Bedside ultrasound will b used to verify correct device location inside the uterine cavity immediately following the insertion. Clinical notes will be reviewed to ensure adherence to planned treatment.
Sponsors
Michael Stitely
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 or older. 2. Immediately post vaginal delivery, within 10 minutes of placental delivery. 3. Previously expressed desire for PPIUD and has signed study consent documents.
Exclusion criteria
1. Active uterine infection and no fever in labour. 2. Having active sexually transmitted infection or other lower genital tract infection. 3. Known to have ruptured membranes for more than 24 hours prior to delivery. 4. Known uterine abnormalities e.g., Bicornuate/septate Uterus, uterine myomas, 5. Manual removal of the placenta. 6. Unresolved postpartum haemorrhage or postpartum uterine atony requiring use of additional oxytocic agents in addition to Active Management of the third stage of labour.
Outcome results
None listed