A Multicenter Analysis of Levonorgestrel-Intrauterine System (LNG-IUS) Use in the Postpartum Period

United States Naval Medical Center, Portsmouth

Status

Withdrawn

Conditions

Contraception

Postpartum Period

Treatments

Device: LNG-IUS

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT01161095

NMCP.2010.0074

Details and patient eligibility

About

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).

Full 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)

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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)