Immediate Versus Delayed Insertion of Intrauterine Contraception After Medical Abortion — INTRAM  

Contraceptive Usage Clinical Trial

Official title: Immediate Versus Delayed Insertion of Intrauterine Contraception at the Time of Medical Abortion- An Open-label, Randomized, Multicenter Study

Status Recruiting

Clinical Trial 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

Clinical Trial Description

Today 90 percent of terminations of pregnancy are medical abortions. Approximately 33 000 medical abortions are performed in Sweden each year and 20-30 percent of these women opt for IUC as post abortion contraception. Thus, the results of this study potentially affect at least 6600-9900 women every year in Sweden alone. A disadvantage with medical abortion compared with surgical abortion is the standard practice of delayed insertion of IUC. It has been shown that 42 percent of women scheduled for delayed insertion after surgical abortion did not return for the follow up and IUC insertion.(5) This problem is common also in medical abortion practice. Immediate insertion could lead to insertion rates close to 100 percent. However, this practice has not been studied for medical abortion.

The background for this trial is the belief that a higher rate of insertion of IUC, perhaps close to 100 percent, within 48 hours after medical abortion, can compensate more than well for a potentially higher rate of expulsion at immediate insertion. A clinically significant difference in IUC use at six months following the medical abortion of at least 20 percent is expected.

This large multicenter, randomized, patient centered clinical trial will investigate the effectiveness, feasibility, continued use, safety and acceptability of immediate insertion of intrauterine contraception within 0-48 hours after a completed medical abortion when compared to delayed IUC insertion at 2-4 weeks post abortion which is current practice.

Aim To study use, safety and patient acceptability of intrauterine contraception after immediate insertion compared with standard insertion 2-4 weeks post medical abortion at 3, 6 and 12 months post abortion.

Drug:

Mirena® (LNG-IUS 52mg), Kyleena® (LNG-IUS 19.5mg), Jaydess® (LNG-IUS 13.5 mg), NovaT® (Cu-IUD, medical device, but due to use outside indication it is included in this application)

Design:

Open label, randomized, controlled, multicenter study. Phase III (therapeutic confirming).

Primary objective:

To study if immediate insertion of intrauterine contraception 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.

Variable:

The proportion of women in each group (immediate or delayed) using IUC as contraception at 6 months post abortion (use vs non-use).

Secondary objectives:

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

Related Conditions & MeSH terms

• Contraceptive Usage

• NCT number: NCT03603145
• Study type: Interventional
• Source: Karolinska Institutet
• Contact: Helena Kopp Kallner, MD, PhD
• Phone: +46704402070
• Email: helena.kopp-kallner@ki.se
• Status: Recruiting
• Phase: Phase 3
• Start date: January 16, 2019
• Completion date: December 31, 2024