Clinical trial NCT01161095: A Multicenter Analysis of Levonorgestrel-Intrauterine System (LNG-IUS) Use in the Postpartum Period
Official title: A Multicenter Analysis of Levonorgestrel-Intrauterine System (LNG-IUS) Use in the Postpartum Period
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Contraception
Postpartum Period
Keywords: Intrauterine Device
Postpartum contraception
Long-acting reversible contraception
Lead sponsor: United States Naval Medical Center, Portsmouth
Sponsor class: FED
First posted: 2010-07-13
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the investigators study is to determine if there is a difference in continuation rates at six months in women who are randomized to have the Levonorgestrel Intrauterine System (LNG-IUS) inserted at two possible time periods: Immediate (defined as after delivery of placenta to 72 hours postpartum) or Interval (defined as after 6 weeks postpartum).

Detailed description: The control arm of our study will be women who are randomized to receive LNG-IUS in the Interval time period. The study arm will consist of women randomized to receiving Immediate placement.

The investigators hypothesize that Immediate placement of IUD in the postpartum period will result in a 20% decrease in continuation rates at six months compared to Interval placement.

Secondary outcome measures that we will obtain include:

* Pain at the time of placement
* Postpartum Depression
* Breastfeeding status
* Postpartum weight retention
* Expulsion Rates
* Bleeding Profile
* Uterine Infection(Endometritis)

Eligibility criteria: Inclusion Criteria:

* All women \>37 weeks gestation who desire LNG-IUS for postpartum contraception who do not have a contraindication as described below will be offered participation in our study.

Exclusion Criteria:

Contraindications to the LNG-IUS include:

* Pregnancy or suspicion of pregnancy
* Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity
* Postpartum endometritis within the past 3 months
* Known or suspected uterine or cervical neoplasia or unresolved, abnormal pap smear
* untreated acute cervicitis or vaginitis including bacterial vaginosis or other lower genital tract infections
* acute liver disease or liver tumor
* hypersensitivity to any component of the product
* known or suspected carcinoma of the breast

Any of these conditions would exclude the patient from receiving these forms of contraception in our study.

In addition the following intrapartum findings, the following would exclude the patient:

* Delivery \<37 weeks
* Intrapartum chorioamnionitis (defined as maternal fever \>100.4 and two of the following conditions: Maternal leukocytosis (greater than 15,000 cells/cubic millimeter), Maternal tachycardia (greater than 100 beats/minute), Fetal tachycardia (greater than 160 beats/minute), Uterine tenderness, Foul odor of the amniotic fluid
* Postpartum Hemorrhage (defined as \>500cc EBL for spontaneous vaginal delivery or \>1000cc for cesarean delivery)

Primary outcomes:
measure: Continuation Rates
timeFrame: 6 months
Secondary outcomes:
measure: Pain at insertion
timeFrame: 1 minute
measure: Postpartum Depression
timeFrame: 6 months
measure: Breastfeeding Status
timeFrame: 6 months
measure: Postpartum weight retention
timeFrame: 6 months
measure: Sexual Function
timeFrame: 6 months
measure: Expulsion Rate
timeFrame: 6 months
measure: Bleeding Profile
timeFrame: 6 months
measure: Infectious morbidity
timeFrame: 6 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for the Medical Sciences
state: Arkansas
city: Portsmouth
country: United States
facility: Naval Medical Center
state: Virginia
Study officials:
References: