Early vs. Interval Postpartum IUD Insertion



Status:Recruiting
Conditions:Contraception, Contraception
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:March 20, 2018
End Date:February 1, 2019
Contact:Marisa Hildebrand, MPH
Email:familyplanningresearch@ucsd.edu
Phone:8583294464

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Early vs. Interval Postpartum IUD Insertion: A Multi-site Randomized Controlled Trial

Intrauterine devices (IUDs) are historically placed at a six-week postpartum visit for women
who desire intrauterine contraception after delivery. A two-week postpartum visit could be a
convenient time for women to receive contraception, including IUDs. Offering women IUDs at
two-weeks postpartum may decrease the risk of undesired pregnancy and rapid repeat pregnancy.
This study will compare IUD insertion at two different times after delivery: two-weeks and
six-weeks postpartum. This will allow researchers to assess whether the timing of IUD
placement affects whether an IUD is expelled, or pushed out of it's ideal location.

The purpose of this study is to determine the proportion of IUDs inserted in the Early
Postpartum (EPP) period that are expelled at 6 months postpartum. This prospective,
multi-site randomized trial will enroll approximately 424 women at three large academic
hospitals in the United States.

Women will be recruited who are interested in receiving a levonorgestrel-IUD or a copper-IUD
after delivery. Postpartum women who desire an IUD will be randomized to EPP IUD insertion
(between 14-28 days PP) or interval postpartum IUD insertion (42-56 days PP) and the
proportion of IUDs expelled will be compared between groups at 6 months postpartum. All women
will be seen in clinic at 6-8 weeks and 6 months postpartum. Women randomized to EPP IUD
placement will be seen at 2-3 weeks postpartum.

Provider perspectives of EPP IUD placement will also be evaluated, as will whether these
attitudes change after 6 to 9 months of providing early postpartum IUDs.

Inclusion Criteria:

- Gave birth less than or equal to 10 days ago

- Desires to use an IUD for Contraception (either copper or levonorgestrel)

- Willing and able to sign an informed consent

- Willing to comply with the study protocol

- Age greater than or equal to 18 years

- English or Spanish speaking

Exclusion Criteria:

- Uterine anomaly or leiomyomata which would not allow placement of an IUD

- Desire for repeat pregnancy in less than 6 months

- Evidence of intrauterine infection (chorioamnionitis or postpartum endometritis)
treated with antibiotics

- Ruptured uterus at the time of delivery

- Received a postpartum tubal ligation or immediate postpartum IUD or implant at
delivery

- Incarcerated women or women with significant cognitive impairment

- 4th degree perineal laceration sustained at delivery

- Any medical contraindication to IUD per the US CDC Medical Eligibility Criteria

- Suspicion for new pregnancy
We found this trial at
4
sites
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Sadia Haider, MD, MPH
Phone: 773-834-4063
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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34800 Bob Wilson Dr,
San Diego, California 92134
(619) 532-6400
Principal Investigator: Antoinette Marengo-Barbick, MD
Phone: 619-807-6551
Naval Medical Center - San Diego We are the largest and most comprehensive military healthcare...
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San Diego, CA
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Albuquerque, New Mexico 87131
(505) 277-0111
Principal Investigator: Lisa Hofler, MD, MPH, MBA
Phone: 505-205-4118
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Albuquerque, NM
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
Principal Investigator: Sarah Averbach, MD, MAS
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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La Jolla, CA
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