A Multicenter Analysis of Levonorgestrel-Intrauterine System (LNG-IUS) Use in the Postpartum Period
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Continuation Rates
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
Immediate
LNG-IUS insertion within the timeframe of delivery of the placenta to 72 hours postpartum
Intervention: LNG-IUS (Device)
Interval
LNG-IUS insertion after 6 weeks postpartum
Intervention: LNG-IUS (Device)
Outcomes
Primary Outcomes
Continuation Rates
Time Frame: 6 months
Primary objective: Determine if there is a difference in continuation rates at six months postpartum in women who have the Levonorgestrel Intrauterine System (LNG-IUS) inserted at two time periods: Immediate (after delivery of placenta to 72 hours postpartum) or Interval (after 6 weeks postpartum). Our analysis will be conducted on all randomized women on an intention to treat basis. Once insertion has occurred, evaluation at 6 months postpartum with the presence or absence of the LNG-IUS in the uterus will be determined to calculate the continuation rate.
Secondary Outcomes
- Expulsion Rate(6 months)
- Breastfeeding Status(6 months)
- Postpartum weight retention(6 months)
- Sexual Function(6 months)
- Bleeding Profile(6 months)
- Infectious morbidity(6 months)
- Postpartum Depression(6 months)
- Pain at insertion(1 minute)