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Monitoring With Ultrasound Imaging of Intrauterine Device (IUD) Position Placed Immediately After Giving Birth

NCT02024672 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 96

Last updated 2017-10-11

No results posted yet for this study

Summary

Intrauterine devices (IUDs) are one of the most effective reversible forms of contraception, and are a good option in the postpartum period for women to avoid a rapid repeat pregnancy. IUDs can be placed immediately postpartum, after delivery of the placenta by either vaginal or cesarean birth. This practice has been shown to be safe, and is recommended by the American College of Obstetricians \& Gynecologists, the World Health Organization and the U.S. Center for Disease Control. Immediate postpartum IUD placement has the advantage of providing contraception at a time that the woman is already accessing medical care, avoiding potential loss to follow up or risk of unintended pregnancy. Additionally, women who have anesthesia for delivery have reduced pain at the time of IUD placement compared to having the IUD placed at the postpartum follow up appointment. Immediate postpartum IUD placement is a relatively new practice in the US and little is known about the expected appearance of IUDs inside the uterus taken with an ultrasound when they have been placed at the time of delivery. It is less likely that IUD strings will be visible at the cervix after immediate postpartum IUD placement due to subsequent uterine involution, which makes it important to monitor correct positioning of the IUD via ultrasound. This study will document normal changes in the positioning of the IUD visualized via ultrasound, and determine if a correlation exists between IUD position and risk of expulsion. Ultrasound surveillance to document IUD position and distance from the fundus, will be performed at 6 weeks, 3 months and 12 months after placement. Symptoms of menstrual bleeding and pain will also be recorded in order to determine if they are correlated with IUD position.

Conditions

  • Contraception
  • Postpartum

Interventions

OTHER

Immediate postpartum placement of IUD

pelvic exam, transvaginal ultrasound (3 during the course of the study), bleeding and symptom diary

Sponsors & Collaborators

Principal Investigators

  • Britt Lunde, MD, MPH · Icahn School of Medicine at Mount Sinai

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2017-09-15
Completion
2017-09-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02024672 on ClinicalTrials.gov