Clinical trial NCT01088178: Levonorgestrel-Intrauterine System (LNG-IUS) Insertion in the Postpartum Period
Official title: Levonorgestrel-Intrauterine System (LNG-IUS) Insertion in the Postpartum Period: A Prospective, Randomized Pilot Study of Three Time Intervals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: Long-Acting Reversible Contraception
Contraceptive Agents
Therapeutic Uses
Contraceptive Agents, Female
Reproductive Control Agents
Pharmacologic Actions
Levonorgestrel
Lead sponsor: United States Naval Medical Center, Portsmouth
Sponsor class: FED
First posted: 2010-03-17
Enrollment: 10
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Continuation Rates of the LNG-IUS when placed postpartum at three time periods
timeFrame: at 6 months
Secondary outcomes:
measure: Expulsion rate of the LNG-IUS when placed postpartum at three time periods
timeFrame: at 3 weeks
measure: Pain at placement
timeFrame: at 1 minute
Other outcomes:
Locations:
city: Portsmouth
country: United States
facility: Naval Medical Center
state: Virginia
Study officials:
References:
citation: Dahlke JD, Terpstra ER, Ramseyer AM, Busch JM, Rieg T, Magann EF. Postpartum insertion of levonorgestrel--intrauterine system at three time periods: a prospective randomized pilot study. Contraception. 2011 Sep;84(3):244-8. doi: 10.1016/j.contraception.2011.01.007. Epub 2011 Feb 24.