Immediate Versus Delayed Insertion of Intrauterine Contraception After Medical Abortion (INTRAM)

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

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

Study Overview

• Status: Recruiting
• Conditions: Contraceptive Usage
• Intervention / Treatment: Procedure: Immediate insertion

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.

• Study Type: Interventional
• Enrollment (Anticipated): 720
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Helena Kopp Kallner, MD, PhD; Phone Number: +46704402070; Email: helena.kopp-kallner@ki.se

Study Locations

• Sweden
  • Falun, Sweden
    • Recruiting
    • Falun hospital
    • Contact: Sara Hogmark, MD
  • Gothenburg, Sweden
    • Recruiting
    • Sahlgrenska Hospital
    • Contact: Helena Hognert, MD, PhD
  • Stockholm, Sweden
    • Recruiting
    • Karolinska University Hospital
    • Contact: Kristina Gemzell Danielsson, MD, PhD
  • Stockholm, Sweden
    • Recruiting
    • South General Hospital
    • Contact: Cecilia Berger, MD, PhD
  • Stockholm, Sweden, 182 88
    • Recruiting
    • Danderyd Hospital
    • Contact: Helena Kopp Kallner, MD, PhD
  • Uppsala, Sweden
    • Recruiting
    • Uppsala Academiska Hospital
    • Contact: Emma Håstad, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate insertion; Randomized to insertion within 48 hours of medical abortion	Procedure: Immediate insertion; Immediate insertion of intrauterine contraception within 48 hours of medical abortion
No Intervention: Standard Insertion; Insertion at 2-4 weeks post medical abortion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in the proportion of women who successfully have the IUC inserted	• Difference in the proportion of women who successfully have the IUC inserted (success versus failure),	10 minutes after (attempted) insertion
Expulsion rate following insertion in both groups	Expulsion rate during 12 months following insertion in both groups evaluated by telephone/email follow up 12 months post abortion (complete, partial or no expulsion.	12 months post insertion
Continued use of IUC	• Continued use of IUC at 12 months post insertion evaluated by telephone follow-up (continued use/voluntary discontinued use, involuntary discontinued use including expulsions etc) reasons for discontinuation will be recorded and subsequent use of other contraceptive methods will be noted)	12 months post abortion
Ease of insertion	Ease of insertion according to health care provider (judged as very easy, moderately-, or very difficult)	10 minutes after (attempted) insertion
Pain at time of insertion assessed as millimeters on a 10cm long unmarked Visual Analogue Scale.	• pain at time of insertion (women will indicate the pain before insertion, at placement of tenaculum, sound and IUC by putting a vertical mark on a 10 cm long horizontal line with a Visual Analogue Scale (VAS) from 0, indicating no pain to 10 indicating worst imaginable pain. Result will be noted in millimeters and entered into case report forms).	10 minutes after (attempted) insertion
Post-abortion bleeding measured as number of days of fresh bleeding	Post-abortion bleeding measured as number of days of uninterrupted fresh bleeding directly following the the abortion.	max 3 months post abortion
Post-abortion bleeding measured as number of days of spotting during the first 3 months post abortion	Post-abortion bleeding measured as number of days of spotting- excluding fresh bleeding and menstruation- during the first 3 months after the abortion.	max 3 months post abortion
Reasons for non-attempted insertion of IUC	• Reasons for non-attempted insertion of IUC (change of mind, heavy bleeding, not coming for insertion, staff being unavailable etc),	within 1 month post abortion
Complications	• Complications (adverse events (AE) and serious AE) bleeding requiring any treatment, uterine perforations and cervical tears, infection requiring treatment with antibiotics, hospitalization for any reason, surgical procedures due to heavy bleeding, incomplete abortions, prolonged bleeding or patient request,	12 months post abortion
Pregnancies occurring during the 12 month follow-up	• Pregnancies occurring during the 12 month follow-up (planned and unplanned, wanted and unwanted, pregnancy outcomes- ectopic, miscarriage, abortion, molar, kept pregnancy),	12 months post abortion
proportion of women who would recommend immediate or delayed insertion of IUC post abortion	• proportion of women who would recommend immediate and delayed insertion of IUC by asking women if they would recommend the procedure to a friend (yes/no, asked at the time of insertion and at the 3, 6 and 12 month follow up),	12 months post abortion
proportion of women who would recommend IUC for post abortion contraception	• Proportion of women who would recommend IUC as post abortion to a friend (yes/no) asked at the time of insertion and at the 3, 6 and 12 month follow up),	12 months post abortion
The proportion of surgical procedures	• The proportion of surgical procedures in total and for each study site (type of procedure, reasons therefore- infection, retained products of conception, prolonged bleeding etc).	3 months post abortion

Collaborators and Investigators

• Sponsor: Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: April 25, 2018
• First Submitted That Met QC Criteria: July 18, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: INTRAM version III

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No