N/A
N=404
Early vs. Interval Postpartum IUD Insertion
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT03462758 ↗Enrolled (actual)
404
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Proportion of Participants With an IUD Expulsion (Complete) at 6 Months — 0; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- IUD (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of California, San Diego
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With an IUD Expulsion (Complete) at 6 Months |
0; 3 | — |
| SECONDARY Proportion of Participants Using an IUD at 6 Months |
139; 141 | — |
| SECONDARY Proportion of Participants With an IUD Expulsion (Partial) at 6 Months |
11; 14 | — |
| SECONDARY Proportion of Participants With a Pelvic Infection Within 6 Months |
0; 3 | — |
| SECONDARY Patient Satisfaction With IUD Assessed on a Five-point "Likert" Scale for Satisfaction, an Ordinal Scale That Measure Levels of Agreement/Disagreement |
116; 129 | — |
| SECONDARY Proportion of Participants With an IUD Perforation at 6 Months |
0; 0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03462758). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.