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

This study is currently recruiting participants.
Verified December 2013 by Mount Sinai School of Medicine
Sponsor:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT02024672
First received: December 27, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Contraception
Postpartum
Other: Immediate postpartum placement of IUD

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ultrasound Surveillance of IUDs Placed Immediately Postpartum

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • IUD-endometrial distance association with expulsion risk [ Time Frame: at 6 weeks after IUD placement ] [ Designated as safety issue: No ]
  • IUD-endometrial distance association with expulsion risk [ Time Frame: at 3 months after IUD placement ] [ Designated as safety issue: No ]
  • IUD-endometrial distance association with expulsion risk [ Time Frame: at 1 year after IUD placement ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Expected normal appearance of IUD on ultrasound and change in appearance over time [ Time Frame: 6 weeks after IUD placement ] [ Designated as safety issue: No ]
  • Expected normal appearance of IUD on ultrasound and change in appearance over time [ Time Frame: 3 months after IUD placement ] [ Designated as safety issue: No ]
  • Expected normal appearance of IUD on ultrasound and change in appearance over time [ Time Frame: 1 year after IUD placement ] [ Designated as safety issue: No ]
  • IUD endometrial distance association with side effects [ Time Frame: 6 weeks after IUD placement ] [ Designated as safety issue: No ]
  • IUD endometrial distance association with side effects [ Time Frame: 1 year after IUD placement ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: December 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Immediate postpartum placement of IUD
Women who plan to have an IUD placed at the time of cesarean section or vaginal delivery
Other: Immediate postpartum placement of IUD
pelvic exam, transvaginal ultrasound (3 during the course of the study), bleeding and symptom diary

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients will be recruited from the group of women receiving prenatal care at Mount Sinai Hospital in New York City and Elmhurst Hospital in Queens. Patients who express an interest in an IUD for contraception after delivery will be given information about immediate postpartum IUDs and the study.

Criteria

Inclusion Criteria:

  • Women >18 years of age
  • English or Spanish speaking
  • Desire postpartum IUD placement, either copper IUD or levonorgestrel IUD

Exclusion Criteria:

  • Contraindications for IUD use (CDC MEDICAL Eligibility Criteria category 3 or 4 for specific IUD)
  • Positive Chlamydia or gonorrhea cervical cultures in past 3 months
  • Immediate postpartum hemorrhage
  • Premature rupture of membranes (PROM) >12h or diagnosis of endometritis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02024672

Contacts
Contact: Britt Lunde, MD, MPH 212-241-3614 Britt.Lunde@mssm.edu
Contact: Julie Gonzalez, MD 212-241-3614 Julie.Gonzalez@mountsinai.org

Locations
United States, New York
Elmhurst Hospital Center Not yet recruiting
Elmhurst, New York, United States, 11373
Contact: Samantha Stimmel, MS3    917-446-4659    samantha.stimmel@mssm.edu   
Contact: Britt Lunde, MD, MPH    718-334-5366    britt.lunde@mssm.edu   
Principal Investigator: Britt Lunde, MD, MPH         
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Samantha Stimmel, MS3    917-446-4659    samantha.stimmel@mssm.edu   
Contact: Britt Lunde, MD, MPH    212-241-3614    britt.lunde@mssm.edu   
Principal Investigator: Britt Lunde, MD, MPH         
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Britt Lunde, MD, MPH Mount Sinai School of Medicine
  More Information

Publications:
Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT02024672     History of Changes
Other Study ID Numbers: GCO 13-1557
Study First Received: December 27, 2013
Last Updated: December 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Intrauterine devices
IUDs
postpartum
contraception

ClinicalTrials.gov processed this record on April 17, 2014