Early vs. Interval Postpartum IUD Insertion (NCT03462758) | Clinical Trial Compass
CompletedNot Applicable
Early vs. Interval Postpartum IUD Insertion
United States404 participantsStarted 2018-03-20
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 Centers for Disease Control (CDC) Medical Eligibility Criteria
* Suspicion for new pregnancy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Participants With an IUD Expulsion (Complete) at 6 Months