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

ISRCTN	ISRCTN71047458
DOI	https://doi.org/10.1186/ISRCTN71047458
Integrated Research Application System (IRAS)	350561
Central Portfolio Management System (CPMS)	72215
Sponsor	Accord (United Kingdom)
Funders	Chief Scientist Office, Scottish Government Health and Social Care Directorate, Edinburgh Family Planning Trust

Submission date: 03/03/2026
Registration date: 10/03/2026
Last edited: 02/06/2026

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
An intrauterine device (IUD) – sometimes also known as a ‘coil’ – is a popular method of contraception. It is a small T-shaped device about the size of a 50 pence coin. It is available in hormonal and non-hormonal (copper) types. The IUD is inserted into the womb by a healthcare professional during a short procedure. This procedure usually involves passing a thin plastic straw containing the IUD through the entrance to the womb (cervix). The plastic insertion tube is then removed leaving the IUD inside the womb.
It is also possible to insert an IUD right after a baby is born. This is known as postpartum intrauterine device insertion, or PPIUD. Previous research has shown that it is very safe to have an IUD inserted at this time. It is often easier and maybe less painful to insert an IUD as the cervix is already wide open to allow the baby to be born. As the womb is larger after birth than it is at any other time, we need to use a different technique to insert a postpartum IUD. The regular plastic IUD insertion tube is not long enough to reach the top of the womb at this time. Therefore, the IUD is usually placed inside the womb using metal ‘tongs’ or forceps.
This study will investigate a plastic ‘straw’ device designed to insert the IUD immediately after normal childbirth (or within 48 hours). It has been made especially for inserting an IUD after birth, which is large enough to reach the top of the womb. This means that it can fit the size and shape of the womb better after birth. This inserter might make the procedure simpler to perform and more comfortable for women than the current method (forceps). If successful, the plastic inserter could help make the IUD a more available contraceptive option for women after childbirth.

Who can participate?
Women who are pregnant and intend on a vaginal birth and wish to receive an intrauterine device (hormonal or non-hormonal) for contraception within the first 48 hours after birth.

What does the study involve?
During pregnancy participants will consent and be randomised to either the investigational device or the standard insertion technique. Shortly after the baby is born one of the midwives or doctors will attend to insert the IUD as per randomisation allocation. During the insertion, participants will be asked to complete a brief pain questionnaire immediately before and after the IUD is fitted (this involves selecting a score on a chart) and a short satisfaction survey. 6 weeks postpartum participants will be asked to attend an in-person follow-up. This will include an ultrasound scan to check the position of the IUD inside the womb, a gentle examination using a speculum (a plastic device that is placed in the vagina and opened to be able to view the cervix) to check for the IUD threads and trim them if necessary and some questions about symptoms, infant feeding and resumption of sex. At 12 weeks postpartum, participants will be followed up again via telephone. They will be asked some questions about symptoms, infant feeding and resumption of sex. This is the last activity they will be involved in during the research study.

What are the possible benefits and risks of participating?
By taking part in this study, we will arrange the follow-up IUD thread check-up with the research team at a time that is convenient for the participant. This appointment will take place in a specialist clinic and replace the standard check-up at a GP practice. We will be able to perform all the usual checks and an ultrasound scan at the same visit. This might mean fewer appointments and a shorter waiting time. Otherwise, there are no direct benefits to the participant taking part, but the results might help to improve the healthcare of patients in the future.
No additional risks have been identified whether the IUD is fitted with the plastic inserter or metal tongs. Known risks of IUD insertion are similar whether the IUD is inserted at the time of birth or not. IUD insertion risks include infection (1 in every 100 people), uterine perforation (1-2 in every 1000 people), device expulsion (1 in every 20 people), pain (variable from person to person) and unusual menstrual bleeding or cramping. There are some extra steps and time that will be required. These include:
1. Screening/consent appointment (up to 30 minutes)
2. Brief questionnaire about pain at the time the IUD is inserted (5 minutes)
3. Follow-up visit at the research clinic instead of GP practice – up to 1 hour
4. Telephone questionnaire – up to 20 minutes

Where is the study run from?
The study will take place in NHS Lothian. The research team is based at NHS Lothian and the University of Edinburgh (UK)

When is the study starting and how long is it expected to run for?
May 2026 to February 2027

Who is funding the study?
The study is funded by the Chief Scientist Office and the Edinburgh Family Planning Trust (UK)

Who is the main contact?
Karen McCabe (research midwife) on 07973 760871 or chalmers.research@ed.ac.uk

Contact information

Mrs Lauren Craig
Public

Usher Building, 57 Little France Road, Edinburgh BioQuarter Gate 3
Edinburgh
EH16 4UX
United Kingdom

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

Dr Michelle Cooper
Scientific

Chalmers Centre
2a Chalmers Street
Edinburgh
EH3 9ES
United Kingdom

ORCID ID	0000-0003-3367-3749
Phone	+44 (0)1315362101
Email	michelle.cooper@ed.ac.uk

Prof Sharon Cameron
Principal investigator

Chalmers Centre
2a Chalmers Street
Edinburgh
EH3 9ES
United Kingdom

ORCID ID	0000-0002-1168-2276
Phone	+44 (0)1315362091
Email	Sharon.Cameron@ed.ac.uk

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Active
Assignment	Single
Purpose	Device feasibility
Scientific title	Use of a dedicated insertion device for immediate postpartum intrauterine contraception provision: a feasibility randomised controlled trial (POP-IN)
Study acronym	POP-IN
Study objectives	1. To assess the feasibility of a definitive trial in terms of recruitment, retention and adherence. 2. To determine the ease and acceptability of insertion from patientS' and providers' perspectives of the inserter for postpartum IUD placement compared to the forceps (standard care)
Ethics approval(s)	Approved 14/10/2025, North West - Greater Manchester South Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8014; gmsouth.rec@hra.nhs.uk), ref: 25/NW/0226
Health condition(s) or problem(s) studied	Contraception
Intervention	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.
Intervention type	Device
Phase	Phase II
Drug / device / biological / vaccine name(s)	PPIUD Cu T 380A
Primary outcome measure(s)	The feasibility of a definitive trial in terms of recruitment measured using the proportion of screened participants who are initially eligible, consented, randomised, confirmed eligible post birth and those who had an IUD inserted, at screening, consent, randomisation and at day 0 (day of insertion) The feasibility of a definitive trial in terms of retention measured using the retention of participants as a proportion of those receiving intervention at 6 and 12 weeks postpartum The feasibility of a definitive trial in terms of adherence measured using protocol adherence (frequency, proportion and nature of protocol deviations) at throughout the trial The acceptability of insertion from patient perspective of the inserter for postpartum IUD placement compared to the forceps (standard care) measured using participant-rated pain during insertion on a 10 cm visual analogue scale at immediately prior to, during and after the insertion procedure The ease of insertion from providers' perspective of the inserter for postpartum IUD placement compared to the forceps (standard care), measured using provider-rated ease of insertion on a 5-point Likert scale at immediately after insertion procedure
Key secondary outcome measure(s)	Complications: infection and uterine perforation measured using adverse event reporting at Day 0, 6 and 12 weeks postpartum Accuracy of the IUD placement and presence/absence of IUD rotation measured using transvaginal pelvic ultrasound at 6 weeks post-insertion (and after insertion if available) IUD expulsion and continuation rates measured using observations by staff or participants at 6 and 12 weeks Patient satisfaction with the insertion procedure measured using 5-point Likert scale at Day 0 and 6 weeks Alternative contraception methods used if the IUD is not in place and pregnancy status measured using self report at 6 and 12 week postpartum
Completion date	28/02/2027

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	16 Years
Upper age limit	70 Years
Sex	Female
Target sample size at registration	120
Key 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
Key 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
Date of first enrolment	27/05/2026
Date of final enrolment	30/11/2026

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

NHS Lothian

Waverley Gate
2-4 Waterloo Place
Edinburgh
EH1 3EG
Scotland

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan	The datasets generated during and/or analysed during the study will be available upon request from Sharon Cameron (Sharon.Cameron@ed.ac.uk)

Editorial Notes

02/06/2026: The date of first enrolment was changed from 01/05/2026 to 27/05/2026.
20/04/2026: The date of first enrolment was changed from 01/04/2026 to 01/05/2026.
10/04/2026: Internal review.
03/03/2026: Study's existence confirmed by the MHRA.