Immediate insertion of intrauterine contraception after medical abortion

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Karolinska Institutet

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Not possible to specify

Decision date (initial)

2024-10-09

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-517082-16-01

EudraCT number

2018-000287-29

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To study if immediate insertion of intrauterine contraception (IUC) is superior to insertion at 2-4 weeks post abortion with regard to number of women using IUC as contraception at 6 months post abortion.

Secondary objectives 1

1. To study if immediate insertion of intrauterine contraception is non- inferior to delayed insertion with regard to safety and acceptability.

Conditions and MedDRA coding

Post medical abortion contraception

Regulatory references

Plan to share IPD

No

IPD plan description

Depends on purpose

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. above 18 years old
2. eligible for medical abortion
3. opting for post abortion Intrauterine contraception
4. able and willing to comply with planned follow up

Exclusion criteria 4

1. contraindication for medical abortion
2. contraindication for intrauterine contraception (contraindications may be present for LNG- IUSs but the woman may still choose a Cu-IUD and thereby enter the study),
3. inability to give informed consent.
4. Septic abortion

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The proportion of women in each group (immediate or delayed) using intrauterine contraception as contraception at 6 months post abortion

Secondary endpoints 12

1. Use of IUC at 3, 6 and 12 months post insertion evaluated by telephone or e-mail follow-up (continued use/voluntary discontinued use, involuntary discontinued use including expulsions etc) reasons for discontinuation will be recorded and subsequent use of other contraceptive methods will be noted)
2. Difference in the proportion of women who successfully have the IUC inserted (success versus failure),
3. Ease of insertion according to health care provider (judged as very easy, easy, moderately, or very difficult)
4. pain at time of insertion (women will indicate the pain before insertion, at placement of tenaculum, sound and IUC by putting a vertical mark on a 10 cm long horizontal line with a Visual Analogue Scale (VAS) from 0, indicating no pain to 10 indicating worst imaginable pain. Result will be noted in millimeters and entered into case report forms).
5. Post-abortion bleeding (number of days of fresh bleeding and spotting after the abortion)
6. Reasons for non-attempted insertion of IUC (change of mind, heavy bleeding, not coming for insertion, staff being unavailable etc),
7. Pregnancies occurring during the 6 and 12 month follow-up (planned and unplanned, wanted and unwanted, pregnancy outcomes- ectopic, miscarriage, abortion, molar, kept pregnancy),
8. Acceptability of immediate and delayed insertion of IUC by asking women if they would recommend the procedure to a friend (yes/no, asked at the time of insertion and at the 3 and 6 month follow up),
9. Acceptability of IUC as post abortion contraception- evaluated as above,
10. Expulsion rate during 12 months following insertion in both groups evaluated by telephone follow up at 3, 6 and 12 months post abortion (complete, partial or no expulsion. The exact day of expulsion will be noted to determine the risk of expulsion as a function of time post insertion),
11. Complications (adverse events (AE) and serious AE) bleeding requiring any treatment, uterine perforations and cervical tears, infection requiring treatment with antibiotics, hospitalization for any reason, surgical procedures due to heavy bleeding, incomplete abortions, prolonged bleeding or patient request,
12. The proportion of surgical procedures in total and for each study site (type of procedure, reasons therefore- infection, retained products of conception, prolonged bleeding etc).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Karolinska Institutet

Sponsor organisation

Karolinska Institutet

Address

Nobels Vag 6

City

Solna

Postcode

171 65

Country

Sweden

Scientific contact point

Organisation

Karolinska Institutet

Contact name

Helena Kopp Kallner

Public contact point

Organisation

Karolinska Institutet

Contact name

Helena Kopp Kallner

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications