Clinical trial NCT02067663: Comparison of the Levonorgestrel IUD and the Copper IUD Placed in the Immediate Postplacental Period: A Prospective Cohort Study
Official title: Comparison of the Levonorgestrel IUD and the Copper IUD Placed in the Immediate Postplacental Period: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Keywords: Postplacental IUD placement
LNG-IUS
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2014-02-20
Enrollment: 123
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women interested in an immediate postpartum IUD, or those who recently had one placed, who are willing to be followed postpartum.

Brief summary: The intrauterine device (IUD) is a safe, highly effective, long acting, and reversible form of contraception. The postpartum period is an important moment for contraceptive intervention; however there are many barriers to women obtaining birth control postpartum. The use of the IUD in the immediate postpartum setting offers many advantages and is considered safe, but the risk of expulsion appears to be higher than with interval insertion. Previous studies have shown the rate of expulsion of the copper IUD in the postplacental period to be in the range of 1-14% by 6-12 months, while the only study of the levonorgestrel IUD in the postplacental period documented a rate of expulsion of 24% by 12 months. While studies related to the copper IUD use ring forceps or the operator's hand for placement of the IUD, the only published study investigating immediate postplacental levonorgestrel IUD insertion utilized the manufacturer's inserter for IUD placement. The investigators therefore ask the question, is there a difference in expulsion rates between levonorgestrel and copper IUDs placed post-placentally when all providers undergo a standardized training, use a standardized insertion technique, and when patient level characteristics are controlled by randomization?

The investigators propose to perform a prospective cohort trial comparing the rates of expulsion for the levonorgestrel and the copper IUD by 3 months postpartum when placed in the uterus within 10 minutes of the delivery of the placenta, using a standardized technique (placement with a ring forceps or the operator's hand) after all providers undergo a formal didactic and skills training. The investigators hypothesis is that the levonorgestrel IUD has a higher rate of expulsion as compared to the copper IUD. Additional objectives include a comparison of the rates of complete IUD expulsion, partial IUD expulsion, unrecognized expulsions, complications, IUD continuation, pregnancy, and satisfaction. Additionally, the investigators will document the natural history of the location of the IUD within the uterus when placed in the immediate postpartum period, utilizing ultrasound at 24 hours, 6 weeks, and 3 months postpartum, to better understand the relationship between position of the IUD and subsequent expulsion.


Eligibility criteria: Inclusion Criteria:

* Women age ≥ 18
* Desire for immediate postpartum IUD or postpartum day #1 after a postplacental IUD placement
* English or Spanish speaking
* Willing to attend 2 follow-up visits

Exclusion Criteria:

* Multiple gestations
* Delivery prior to 35 weeks gestational age
* Allergy or sensitivity to any component of either IUD (including polyethylene, levonorgestrel or copper)
* Cesarean delivery
* Postpartum hemorrhage (estimated blood loss \> 500 mL)
* Chorioamnionitis
* Abnormal uterine anatomy (including uterine anomaly or large fibroids)
* Treated for Chlamydia or Gonorrhea during pregnancy without a subsequent negative follow-up test
* Current cervical cancer or carcinoma in situ
* Current breast cancer
* Wilson's disease
* If enrolling postpartum after IUD has already been placed, women will be excluded if the provider used an insertion technique other than using the ring forceps or the operator's hand

Primary outcomes:
measure: IUD Expulsion Rate
timeFrame: 3 months postpartum
Secondary outcomes:
measure: Pregnancy
timeFrame: 6 weeks
measure: Pregnancy
timeFrame: 3 months
measure: Complications
timeFrame: 3 months
measure: Satisfaction
timeFrame: 3 months
measure: Intrauterine Device Expulsion (Day 1)
timeFrame: Day 1
measure: Intrauterine Device Expulsion (6 Weeks)
timeFrame: 6 weeks
measure: Intrauterine Device Expulsion by 12 Weeks Postpartum
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Stephanie Teal, MD
role: PRINCIPAL_INVESTIGATOR
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