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

inköping University, Department of clical and Experimental Medicine0 个研究点目标入组 600 人开始时间: 2017年7月14日最近更新: 2021年6月7日

适应症

试验速览

暂无简介。

•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

发起方

inköping University, Department of clical and Experimental Medicine