Immediate Versus Delayed Insertion of Intrauterine Contraception After Medical Abortion

NCT ID: NCT03603145

Last Updated: 2023-05-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 720 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-16
• Study Completion Date: 2024-12-31

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

Detailed 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.

Conditions

Contraceptive Usage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Immediate insertion

Randomized to insertion within 48 hours of medical abortion

Group Type: EXPERIMENTAL

Immediate insertion

Intervention Type: PROCEDURE

Immediate insertion of intrauterine contraception within 48 hours of medical abortion

Standard Insertion

Insertion at 2-4 weeks post medical abortion

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Immediate insertion

Immediate insertion of intrauterine contraception within 48 hours of medical abortion

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 18 years and older,
• eligible for medical abortion,
• opting for post abortion IUC,
• able and willing to comply with planned follow up.

Exclusion Criteria

• 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
• If any of the following conditions are present an individual evaluation and decision must be done before inclusion: pelvic or genital infection, cervicitis, immunocompromised women, untreated cervical dysplasia, neoplasia in cervix or uterus, acute liver disease or hepatic neoplasia, migraine or other very severe headache, icterus, high uncontrolled blood pressure, serious arterial disease i.e. stroke or myocardial infarction, acute venous thrombosis

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Helena Kopp Kallner

Associate professor, senior consultant obstetrics and gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helena Kopp Kallner, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institute, danderyd Hospital

Locations

Falun Hospital

Falun, , Sweden

Site Status: RECRUITING

Sahlgrenska Hospital

Gothenburg, , Sweden

Site Status: RECRUITING

Danderyd Hospital

Stockholm, , Sweden

Site Status: RECRUITING

Karolinska University Hospital

Stockholm, , Sweden

Site Status: RECRUITING

South General Hospital

Stockholm, , Sweden

Site Status: RECRUITING

Uppsala Academiska Hospital

Uppsala, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Helena Kopp Kallner, MD, PhD

Role: CONTACT

helena.kopp-kallner@ki.se

+46704402070

Facility Contacts

Sara Hogmark, MD

Role: primary

Helena Hognert, MD, PhD

Role: primary

Helena Kopp Kallner, MD, PhD

Role: primary

Kristina Gemzell Danielsson, MD, PhD

Role: primary

Cecilia Berger, MD, PhD

Role: primary

Emma Håstad, MD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 37614066 (View on PubMed)

Other Identifiers

INTRAM version III

Identifier Type: -

Identifier Source: org_study_id