N/A
Completed N=404
Early vs. Interval Postpartum IUD Insertion
Source: ClinicalTrials.gov NCT03462758 ↗Enrolled (actual)
404
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcomePrimary: Proportion of Participants With an IUD Expulsion (Complete) at 6 Months — 0; 3 Participants
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.
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 | — |
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. Informational only — not medical advice.