Levonorgestrel-Intrauterine System (LNG-IUS) Insertion in the Postpartum Period



Status:Completed
Conditions:Contraception
Therapuetic Areas:Reproductive
Healthy:No
Age Range:16 - 45
Updated:4/2/2016
Start Date:November 2009
End Date:July 2010
Contact:Joshua D Dahlke, MD
Email:joshua.dahlke@med.navy.mil
Phone:757-953-4503

Use our guide to learn which trials are right for you!

Levonorgestrel-Intrauterine System (LNG-IUS) Insertion in the Postpartum Period: A Prospective, Randomized Pilot Study of Three Time Intervals

The investigators study is a prospective randomized trial of women undergoing the
levonorgestrel intrauterine system (LNG-IUS: Mirena©, Bayer) at three separate time periods:
immediate post placental (IPP) defined as insertion within 10 min delivery of placenta,
early post partum (EP) defined as insertion after 10 min but within 72hrs postpartum, or
interval (INT) insertion defined as insertion after 6wks postpartum. This is a pilot study
in preparation for a multicenter, prospective randomized study of long-acting reversible
contraception in the postpartum period.


Inclusion Criteria:

- All reproductive age women who express a desire for the LNG-IUS (Mirena©) at routine
questioning at their 36-38 week prenatal appointment or upon admission to labor and
delivery are eligible for 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 our study.

- Delivery <36 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)

- Cesarean delivery if randomized to IPP or EP placement
We found this trial at
1
site
Portsmouth, Virginia 23507
?
mi
from
Portsmouth, VA
Click here to add this to my saved trials