NCT03462758: EPPIUD

Early vs. Interval Postpartum IUD Insertion

Completed NA Results posted Last updated 13 April 2023

What this trial tests

NA trial testing IUD in Contraception in 404 participants. Completed in 31 December 2022.

Timeline

20 March 2018

Primary endpoint
14 August 2022

31 December 2022

Quick facts

Lead sponsor	University of California, San Diego
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	404
Start date	20 March 2018
Primary completion	14 August 2022
Estimated completion	31 December 2022
Sites	4 locations across United States

Drugs / interventions tested

• IUD

Conditions studied

• Contraception — all drugs for Contraception →

Sponsor

University of California, San Diego

Who can join

18 and older, female only, with Contraception. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Participants With an IUD Expulsion (Complete) at 6 Months Primary · 6 months postpartum

Complete IUD expulsion will be defined as an IUD which no longer in the uterus on speculum exam and transvaginal ultrasound will be performed on all patients at 6 months postpartum to confirm IUD use

Group	Value	95% CI
Interval Postpartum IUD Placement	0
Early Postpartum IUD Placement	3

Proportion of Participants Using an IUD at 6 Months Secondary · 6 months postpartum

IUD utilization will be defined as intrauterine use of an IUD at 6 months postpartum. A speculum exam and transvaginal ultrasound will be performed on all patients at 6 months postpartum to confirm IUD use

Group	Value	95% CI
Interval Postpartum IUD Placement	139
Early Postpartum IUD Placement	141

Proportion of Participants With an IUD Expulsion (Partial) at 6 Months Secondary · 6 months

Partial IUD expulsions will be diagnosed in any participant found to have an IUD in which part of the body of the IUD is noted to be coming through the external cervical os on speculum exam.

Group	Value	95% CI
Interval Postpartum IUD Placement	11
Early Postpartum IUD Placement	14

Proportion of Participants With a Pelvic Infection Within 6 Months Secondary · 6 months

Pelvic infection requiring antibiotics will be ascertained by patient report and/or medical record review.

Group	Value	95% CI
Interval Postpartum IUD Placement	0
Early Postpartum IUD Placement	3

Patient Satisfaction With IUD Assessed on a Five-point "Likert" Scale for Satisfaction, an Ordinal Scale That Measure Levels of Agreement/Disagreement Secondary · 6 months

Participants are asked how much they agree with the statement "I am satisfied with using this IUD." Answers are valued 1-5, with 1 Strongly Agree, 2 Agree, 3 Neutral, 4 Disagree, and 5 Strongly Disagree. 1=Strongly Agree is considered the best outcome, 5=Strongly disagree is considered the worst outcome. Outcome reported is those who were very satisfied or satisfied.

Group	Value	95% CI
Interval Postpartum IUD Placement	116
Early Postpartum IUD Placement	129

Proportion of Participants With an IUD Perforation at 6 Months Secondary · 6 months

IUD perforations through the uterus will be diagnosed when an IUD visible is not visible on transvaginal ultrasound of the uterus but is visible on x-ray of the abdomen or pelvis.

Group	Value	95% CI
Interval Postpartum IUD Placement	0
Early Postpartum IUD Placement	0

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Early vs Interval Postpartum Intrauterine Device Placement: A Randomized Clinical Trial.
   Averbach S, Kully G, Hinz E, Dey A, et al · · 2023 · cited 8× · PMID 36943214 · DOI 10.1001/jama.2023.1936
2. Pain With Early Postpartum Intrauterine Device Placement.
   Berkley HH, Lutgendorf MA, Kully G, Raiciulescu S, et al · · 2025 · PMID 41000085 · DOI 10.1097/og9.0000000000000088
3. Expulsion rates 12 months after early versus interval postpartum intrauterine device placement: a randomized trial.
   Averbach S, Vaida F, Hinz E, Kully G, et al · · 2025 · PMID 40895814 · DOI 10.1016/j.xagr.2025.100547