NCT02024672

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2013

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

December 27, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 31, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2017

Completed
Last Updated

October 11, 2017

Status Verified

October 1, 2017

Enrollment Period

3.8 years

First QC Date

December 27, 2013

Last Update Submit

October 10, 2017

Conditions

ContraceptionPostpartum

Keywords

Intrauterine devicesIUDspostpartumcontraception

Outcome Measures

Primary Outcomes (3)

  • IUD-endometrial distance association with expulsion risk

    at 6 weeks after IUD placement

  • IUD-endometrial distance association with expulsion risk

    at 3 months after IUD placement

  • IUD-endometrial distance association with expulsion risk

    at 1 year after IUD placement

Secondary Outcomes (5)

  • Expected normal appearance of IUD on ultrasound and change in appearance over time

    6 weeks after IUD placement

  • Expected normal appearance of IUD on ultrasound and change in appearance over time

    3 months after IUD placement

  • Expected normal appearance of IUD on ultrasound and change in appearance over time

    1 year after IUD placement

  • IUD endometrial distance association with side effects

    6 weeks after IUD placement

  • IUD endometrial distance association with side effects

    1 year after IUD placement

Study Arms (1)

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

Interventions

Immediate postpartum placement of IUDOTHER

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

Immediate postpartum placement of IUD

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Elmhurst Hospital Center

Elmhurst, New York, 11373, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (7)

  • ACOG Practice Bulletin No. 121: Long-acting reversible contraception: Implants and intrauterine devices. Obstet Gynecol. 2011 Jul;118(1):184-196. doi: 10.1097/AOG.0b013e318227f05e. No abstract available.

    PMID: 21691183BACKGROUND

  • Medical Eligibility Criteria for Contraceptive Use: A WHO Family Planning Cornerstone. 4th edition. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK138639/

    PMID: 23741782BACKGROUND

  • Centers for Disease Control and Prevention (CDC). Update to CDC's U.S. Medical Eligibility Criteria for Contraceptive Use, 2010: revised recommendations for the use of hormonal contraception among women at high risk for HIV infection or infected with HIV. MMWR Morb Mortal Wkly Rep. 2012 Jun 22;61(24):449-52.

    PMID: 22717514BACKGROUND

  • Levi E, Cantillo E, Ades V, Banks E, Murthy A. Immediate postplacental IUD insertion at cesarean delivery: a prospective cohort study. Contraception. 2012 Aug;86(2):102-5. doi: 10.1016/j.contraception.2011.11.019. Epub 2012 Jan 20.

    PMID: 22264666BACKGROUND

  • Faundes D, Bahamondes L, Faundes A, Petta C, Diaz J, Marchi N. No relationship between the IUD position evaluated by ultrasound and complaints of bleeding and pain. Contraception. 1997 Jul;56(1):43-7. doi: 10.1016/s0010-7824(97)00072-3.

    PMID: 9306030BACKGROUND

  • Faundes D, Perdigao A, Faundes A, Bahamondes L, Petta CA. T-shaped IUDs accommodate in their position during the first 3 months after insertion. Contraception. 2000 Oct;62(4):165-8. doi: 10.1016/s0010-7824(00)00167-0.

    PMID: 11137069BACKGROUND

  • Shimoni N, Davis A, Westhoff C. Can ultrasound predict copper IUD expulsion after medical abortion? Poster presentation at NAF 2012 conference, Columbia University Medical Center.

    BACKGROUND

Study Officials

  • Britt Lunde, MD, MPH

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2013

First Posted

December 31, 2013

Study Start

December 1, 2013

Primary Completion

September 15, 2017

Study Completion

September 15, 2017

Last Updated

October 11, 2017

Record last verified: 2017-10

Locations

US(2)