TerminatedNot Applicable

Postplacental Mirena IUD Insertion and Estimating Expulsion Rates.

Stopped: Suspended to determine if Mirena device could be charged to patient insurance

4 participantsStarted 2010-09-07

Plain-language summary

This study aims to demonstrate that the expulsion rate is increased but acceptable when inserting Mirena IUDs immediately postpartum, termed 'postplacental IUD insertion'. The investigators will compare the postplacental insertion expulsion rate estimate with rates reported in the literature for 6 week postpartum insertion, which is currently the American standard for IUD insertion postpartum. Secondary outcomes will also be examined; endometritis, uterine perforation, continuation and pregnancy among others.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * age 18 or greater * obstetric patient in greater Portland, ME area Exclusion Criteria: * Evidence of chorioamnionitis (persistent fetal tachycardia, intra-partum fever \>38.0) * prolonged rupture of membranes (greater than 24 hours) * intrauterine fetal demise * use of general anesthesia at time of delivery * postpartum hemorrhage (\>500ml vaginal, \>1000ml cesarean) * magnesium administration in labor due to HELLP syndrome or preeclampsia * preterm delivery.

What they're measuring

Number of Participants Who Expelled IUDs by12 Weeks Postpartum

Timeframe: up to 12 weeks postpartum

Trial details

NCT IDNCT01230242

SponsorRebecca Hunt

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-10-27

Results submitted2021-08-30

View on ClinicalTrials.gov More Estimating Rates of Expulsion trials