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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02024672
First Posted: December 31, 2013
Last Update Posted: October 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Teva Pharmaceuticals USA
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai
  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 Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • IUD-endometrial distance association with expulsion risk [ Time Frame: at 6 weeks after IUD placement ]
  • IUD-endometrial distance association with expulsion risk [ Time Frame: at 3 months after IUD placement ]
  • IUD-endometrial distance association with expulsion risk [ Time Frame: at 1 year after IUD placement ]

Secondary Outcome Measures:
  • Expected normal appearance of IUD on ultrasound and change in appearance over time [ Time Frame: 6 weeks after IUD placement ]
  • Expected normal appearance of IUD on ultrasound and change in appearance over time [ Time Frame: 3 months after IUD placement ]
  • Expected normal appearance of IUD on ultrasound and change in appearance over time [ Time Frame: 1 year after IUD placement ]
  • IUD endometrial distance association with side effects [ Time Frame: 6 weeks after IUD placement ]
  • IUD endometrial distance association with side effects [ Time Frame: 1 year after IUD placement ]

Enrollment: 96
Study Start Date: December 2013
Study Completion Date: September 15, 2017
Primary Completion Date: September 15, 2017 (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, or women who have had 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02024672


Locations
United States, New York
Elmhurst Hospital Center
Elmhurst, New York, United States, 11373
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Britt Lunde, MD, MPH Icahn School of Medicine at Mount Sinai
  More Information

Publications:
Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02024672     History of Changes
Other Study ID Numbers: GCO 13-1557
First Submitted: December 27, 2013
First Posted: December 31, 2013
Last Update Posted: October 11, 2017
Last Verified: October 2017

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