Early insertion of a hormonal intrauterine device after childbirth

Immediate post partum LNG-IUS insertion or standard insertion procedure after childbirth An open-label, randomized, multicenter study - Early insertion of LNG-IUS after childbirth

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001945-29-SE

Enrollment

600

Registered

2017-07-14

Start date

2017-09-20

Completion date

Unknown

Last updated

2021-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception MedDRA version: 20.0 Level: LLT Classification code 10073728 Term: Hormonal contraception System Organ Class: 100000022223 MedDRA version: 20.0 Level: PT Classification code 10010808 Term: Contraception System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Mirena Product Name: Mirena Pharmaceutical Form: Intrauterine delivery system

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Women opting for LNG-IUS for contraception post partum • >18 and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Complicated instrumental delivery (as judged by nurse-midwife or physician) or caesarean section delivery • Known hypersensiblity/allergy to levonorgestrel or any of the substances added to the LNG-IUS • Known abnormal uterine cavity • Preterm delivery ( 1000ml • Uterine atony postpartum • Placental retention • Therapeutic antibiotic treatment during delivery, (antibiotics used only as prophylaxis is accepted) • History of breast cancer • If any of the following conditions are present an evaluation and decision by a physician 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

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to study if immediate insertion of LNG-IUS post-partum is non-inferior to golden standard (insertion six to eight weeks postpartum) with regard to unintended pregnancies measured as number of abortions.;Secondary Objective: The secondary objectives are to study if immediate insertion of LNG-IUS postpartum is non-inferior to golden standard (insertion six to eight weeks postpartum) with regard to efficacy, safety and acceptability. ;Primary end point(s): Number of abortions within one year after insertion of LNG-IUS.;Timepoint(s) of evaluation of this end point: 2, 4, 8 weeks and 6 and 12 months after insertion	—

Measure

Time frame

Main Objective: The primary objective is to study if immediate insertion of LNG-IUS post-partum is non-inferior to golden standard (insertion six to eight weeks postpartum) with regard to unintended pregnancies measured as number of abortions.;Secondary Objective: The secondary objectives are to study if immediate insertion of LNG-IUS postpartum is non-inferior to golden standard (insertion six to eight weeks postpartum) with regard to efficacy, safety and acceptability. ;Primary end point(s): Number of abortions within one year after insertion of LNG-IUS.;Timepoint(s) of evaluation of this end point: 2, 4, 8 weeks and 6 and 12 months after insertion

—

Secondary

Measure	Time frame
Secondary end point(s): • The proportion of women who successfully have the LNG-IUS inserted at the insertion visit (visit 1 early insertion, visit 2 late insertion) • The rate of expulsions during 12 months • Assessment of reasons for discontinuation of the LNG-IUS method • Assessment of reasons for non-insertion of LNG-IUS at the insertion visit (visit 1 early insertion, visit 2 late insertion) • Pain reported at the time of insertion • Number of days and amount of post-partum bleeding • Questions for acceptability • Occurrence of complications • Infant growth (weight, height, head circumference) at twelve months post insertion. ;Timepoint(s) of evaluation of this end point: 2, 4, 8 weeks and 6 and 12 months after insertion apart from infant growth that will be evaluated after 12 months only	—

Measure

Time frame

Secondary end point(s): • The proportion of women who successfully have the LNG-IUS inserted at the insertion visit (visit 1 early insertion, visit 2 late insertion) • The rate of expulsions during 12 months • Assessment of reasons for discontinuation of the LNG-IUS method • Assessment of reasons for non-insertion of LNG-IUS at the insertion visit (visit 1 early insertion, visit 2 late insertion) • Pain reported at the time of insertion • Number of days and amount of post-partum bleeding • Questions for acceptability • Occurrence of complications • Infant growth (weight, height, head circumference) at twelve months post insertion. ;Timepoint(s) of evaluation of this end point: 2, 4, 8 weeks and 6 and 12 months after insertion apart from infant growth that will be evaluated after 12 months only

—

Countries

Sweden

Contacts

Public ContactJan brynhildsen

Linköping University

jan.brynhildsen@liu.se46101030000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026