Immediate Versus Delayed Insertion of Intrauterine Contraception After Medical Abortion
INTRAM
1 other identifier
interventional
720
1 country
6
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2019
Longer than P75 for phase_3
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2018
CompletedFirst Posted
Study publicly available on registry
July 27, 2018
CompletedStudy Start
First participant enrolled
January 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedMay 1, 2023
April 1, 2023
5 years
April 25, 2018
April 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
use of intrauterine contraception at 6 months post abortion
use of intrauterine contraception at 6 months post abortion in both groups evaluated through follow up by telephone/email.
6 months post abortion
Secondary Outcomes (13)
Difference in the proportion of women who successfully have the IUC inserted
10 minutes after (attempted) insertion
Expulsion rate following insertion in both groups
12 months post insertion
Continued use of IUC
12 months post abortion
Ease of insertion
10 minutes after (attempted) insertion
Pain at time of insertion assessed as millimeters on a 10cm long unmarked Visual Analogue Scale.
10 minutes after (attempted) insertion
- +8 more secondary outcomes
Study Arms (2)
Immediate insertion
EXPERIMENTALRandomized to insertion within 48 hours of medical abortion
Standard Insertion
NO INTERVENTIONInsertion at 2-4 weeks post medical abortion
Interventions
Immediate insertion of intrauterine contraception within 48 hours of medical abortion
Eligibility Criteria
You may qualify if:
- years and older,
- eligible for medical abortion,
- opting for post abortion IUC,
- able and willing to comply with planned follow up.
You may not qualify if:
- Contraindication for medical abortion or
- Contraindication for IUC (contraindications may be present for LNG-IUSs but the woman may still choose a Cu-IUD and thereby enter the study),
- inability to give informed consent.
- Septic abortion
- Known hypersensiblity/allergy to levonorgestrel or any of the substances added to the LNG-IUS
- Known abnormal uterine cavity
- Chorioamnionitis
- Abortion associated bleeding \> 1000ml
- Uterine atony postabortion
- Placental retention
- Therapeutic antibiotic treatment during abortion, (antibiotics used only as prophylaxis is accepted)
- History of breast cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Falun Hospital
Falun, Sweden
Sahlgrenska Hospital
Gothenburg, Sweden
Danderyd Hospital
Stockholm, 182 88, Sweden
Karolinska University Hospital
Stockholm, Sweden
South General Hospital
Stockholm, Sweden
Uppsala Academiska Hospital
Uppsala, Sweden
Related Publications (1)
Hogmark S, Envall N, Gemzell-Danielsson K, Kopp Kallner H. 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. Acta Obstet Gynecol Scand. 2023 Dec;102(12):1694-1702. doi: 10.1111/aogs.14662. Epub 2023 Aug 23.
PMID: 37614066DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Helena Kopp Kallner, MD, PhD
Karolinska Institute, danderyd Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor, senior consultant obstetrics and gynecology
Study Record Dates
First Submitted
April 25, 2018
First Posted
July 27, 2018
Study Start
January 16, 2019
Primary Completion
December 31, 2023
Study Completion
December 31, 2024
Last Updated
May 1, 2023
Record last verified: 2023-04