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NCT03603145: INTRAM
Immediate Versus Delayed Insertion of Intrauterine Contraception After Medical Abortion
Phase 3 trial testing Immediate insertion in Contraceptive Usage in 720 participants. Status unknown.
31 December 2023
Quick facts
| Lead sponsor | Karolinska Institutet |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 720 |
| Start date | 16 January 2019 |
| Primary completion | 31 December 2023 |
| Estimated completion | 31 December 2024 |
| Sites | 6 locations across Sweden |
Drugs / interventions tested
- Immediate insertion
Conditions studied
- Contraceptive Usage — all drugs for Contraceptive Usage →
Sponsor
Karolinska Institutet
Who can join
18 and older, female only, with Contraceptive Usage. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
PICO: Population: Women with unwanted pregnancy having a medical abortion and fulfilling inclusion and without exclusion criteria and opting for IUC as post abortion contraception. The medical abortion will be carried out according to the Swedish national evidence based guidelines. Intervention: Randomized to insertion of IUC within 48 hours after medical abortion. Control: Randomized to insertion of IUC at the time of a follow-up visit scheduled 2 to 4 weeks after the abortion according to routine care. Objectives: Evaluation of use of IUC, feasibility, safety, compliance, and acceptability of immediate insertion of IUC 0 to 48 hours after medical abortion compared with delayed IUC insertion at 2 to 4 weeks post abortion. The primary outcome measure will be the use of IUC at 6 months in both groups evaluated by telephone calls/emails follow up. Time plan: Planning: -March 2018 Study start: May 2018 End of recruitment: April 2020 Last patient Last visit April 2021 Analysis: 2021 Report of primary outcome and Safety: 2021
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
One-year follow up of contraceptive use and pregnancy rates after early medical abortion: Secondary outcomes from a randomized controlled trial of immediate post-abortion placement of intrauterine devices.
Hogmark S, Envall N, Gemzell-Danielsson K, Kopp Kallner H. · · 2023 · cited 2× · PMID 37614066 · DOI 10.1111/aogs.14662 -
Immediate and delayed placement of the intrauterine device after abortion: a systematic review and meta-analysis.
Lou Y, Tang S, Sheng Z, Lian H, et al · · 2024 · PMID 38762680 · DOI 10.1038/s41598-024-62327-1
Verify or expand the search:
- PubMed search for NCT03603145
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03603145 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Karolinska Institutet
- Last refreshed: 1 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03603145.
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