Last reviewed · How we verify

NCT03603145: INTRAM

Immediate Versus Delayed Insertion of Intrauterine Contraception After Medical Abortion

Status unknown Phase 3 Last updated 1 May 2023
What this trial tests

Phase 3 trial testing Immediate insertion in Contraceptive Usage in 720 participants. Status unknown.

Timeline
16 January 2019
Primary endpoint
31 December 2023
31 December 2024

Quick facts

Lead sponsorKarolinska Institutet
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment720
Start date16 January 2019
Primary completion31 December 2023
Estimated completion31 December 2024
Sites6 locations across Sweden

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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:

Other recruiting trials for Contraceptive Usage

Currently open trials in the same condition.

Other Karolinska Institutet trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing