Early insertion of a hormonal intrauterine device after childbirth
- Conditions
- ContraceptionMedDRA version: 20.0Level: LLTClassification code 10073728Term: Hormonal contraceptionSystem Organ Class: 100000022223MedDRA version: 20.0Level: PTClassification code 10010808Term: ContraceptionSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]
- Registration Number
- EUCTR2017-001945-29-SE
- Lead Sponsor
- inköping University, Department of clical and Experimental Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 600
•Women opting for LNG-IUS for contraception post partum
•>18 and < 36 years old at the time of inclusion
•Delivery after pregnancy week 36+6 according to ultrasound dating
•Vaginal delivery or uncomplicated instrumental delivery as judged by nurse-midwife or physician
•Written informed consent
•LNG-IUS insertion possible within 48 hours post partum
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•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 (<37+0 weeks)
•Chorioamnionitis
•Delivery associated bleeding > 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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) <br>•The rate of expulsions during 12 months<br>•Assessment of reasons for discontinuation of the LNG-IUS method<br>•Assessment of reasons for non-insertion of LNG-IUS at the insertion visit (visit 1 early insertion, visit 2 late insertion)<br>•Pain reported at the time of insertion<br>•Number of days and amount of post-partum bleeding<br>•Questions for acceptability<br>•Occurrence of complications<br>•Infant growth (weight, height, head circumference) at twelve months post insertion. <br>;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