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Immediate Versus Delayed Insertion of Intrauterine Contraception After Medical Abortion

NCT03603145 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 720

Last updated 2023-05-01

No results posted yet for this study

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

Conditions

  • Contraceptive Usage

Interventions

PROCEDURE

Immediate insertion

Immediate insertion of intrauterine contraception within 48 hours of medical abortion

Sponsors & Collaborators

Principal Investigators

  • Helena Kopp Kallner, MD, PhD · Karolinska Institute, danderyd Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-16
Primary Completion
2023-12-31
Completion
2024-12-31

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03603145 on ClinicalTrials.gov