Harper 2014.
Trial name or title | Mirena Intrauterine System Timing of Insertion: A Randomized Controlled Trial (MISTIC) |
Methods | Location and time frame: St. Louis, MO (USA), October 2010 to December 2012. Design: randomized controlled trial, open label Sample size calculation and outcome of focus: no mention |
Participants | General with N: 53 women, enrolled ≥ 36 weeks gestation at study hospital Inclusion criteria: 14 to 45 years, vaginal delivery at study hospital, sexually active with male partner, no tubal ligation or hysterectomy, not currently using contraception, desire reversible contraception, resides in St. Louis City or County, requests LNG‐IUS for contraception Exclusion criteria: allergy to LNG‐IUS, cesarean delivery, cervical cancer, breast cancer, active liver disease, untreated cervicitis, uterine anomaly or fibroids preventing IUS placement, delivery < 36 weeks, chorioamnionitis, prolonged rupture of membranes (> 18 hours) |
Interventions | LNG‐IUS insertion Treatment: immediate postplacental (within 10 minutes) Comparison: standard (4 to 6 weeks postpartum) |
Outcomes | LNG‐IUS in place, IUS expulsion, uterine perforation, intrauterine infection Assessment times: 4 to 6 weeks and 6 months postpartum |
Starting date | October 2010; expected completion December 2012 |
Contact information | Lorie M. Harper MD; listed as University of Washington School of Medicine, but more recently at University of Alabama at Birmingham (205) 934‐9999 |
Notes | ClinicalTrials.gov states trial is completed. No report identified. Unable to obtain further information from investigator. |