A study to investigate a tailor-made device designed to insert an intrauterine contraceptive device (IUD) immediately after childbirth

Use of a dedicated insertion device for immediate postpartum intrauterine contraception provision: a feasibility randomised controlled trial (POP-IN)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN71047458

Enrollment

120

Registered

2026-03-10

Start date

2026-05-27

Completion date

Unknown

Last updated

2026-06-15

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

Conditions

Contraception Pregnancy and Childbirth

Interventions

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

Eligibility

Sex/Gender

Female

Age

16 Years to 70 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Countries

Scotland, United Kingdom

Contacts

Public ContactLauren Craig

POP-IN.trial@ed.ac.uk+44 (0)131 651 9977

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 21, 2026