Use of a dedicated insertion device for immediate postpartum intrauterine contraception provision: a feasibility randomised controlled trial (POP-IN)
Contraception
The device under investigation is a postpartum IUD (PPIUD), which consists of a dedicated postpartum inserter and a pre-loaded (copper) CU-IUD. The postpartum inserter is a long tube of plastic, which is a longer, wider version of some of the standard (non-postpartum) IUD inserters in use in the UK which better accommodates the anatomy of the womb immediately post-birth. The main aim of this study is to assess the feasibility of running a study, which will demonstrate the safety and efficacy of this PPIUD inserter compared to the current technique (long metal forceps). The target population are individuals who are within 48 hours of a vaginal birth and who wish to receive immediate postpartum insertion of a hormonal or copper IUD for ongoing contraception. Participants will be randomised in a 3:1 allocation to the investigational device or standard insertion technique, based on single-sequence random assignment. This will be achieved using bespoke web-based randomisation software provided and maintained by the Edinburgh Clinical Trials Unit (ECTU). Randomisation will take place after informed consent and screening eligibility have been confirmed, prior to childbirth. Participants will be randomised to receive their choice of IUD (hormonal or copper) using either the investigational device (n = 90) or through the standard insertion technique using metal forceps (n = 30). In both cases, the IUD itself will remain inside the uterus, but the insertion device (plastic tube or forceps) is removed immediately after placing the IUD. Two study visits will take place at 6 and 12 weeks following IUD insertion to gather study data. Week 6 follow-up will be in-person, and the week 12 follow-up will be conducted by telephone. The total duration of participant involvement will depend on when they are recruited during pregnancy but is expected to be a minimum of 3 months and a maximum of 9 months.
1. Age 16 years or over 2. Currently pregnant 3. Intending a vaginal birth 4. Wishing to receive an intrauterine device (hormonal or non-hormonal) for contraception within the first 48 hours after birth 5. Suitable to have an IUD for contraception 6. Fluent in written/spoken English 7. Capacity to provide informed consent 8. Willingness to be randomised to investigational device
1. Abnormal uterine anatomy e.g. large fibroids, Mullerian malformation 2. Pre-existing conditions that are in category 3 or 4 of the UK Medical Eligibility Criteria for use of IUD 3. Non-vaginal birth, e.g. unplanned or emergency Caesarean-section 4. Suspected or confirmed pelvic or intrauterine infection or systemic sepsis at time of insertion 5. Prolonged rupture of membranes (>36 hours between ROM and delivery*) prior to insertion 6. Unresolved postpartum haemorrhage 7. No longer consenting to take part in the trial, i.e. willing to have their chosen IUD inserted as part of the trial post childbirth