Please select the eligibility criteria that correspond to the clinical trial below.
Title: Levonorgestrel-Intrauterine System (LNG-IUS) Insertion in the Postpartum Period: A Prospective, Randomized Pilot Study of Three Time Intervals
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.


Options:
A: Inclusion Criteria:

* Women ages 18-45
* Pregnant and greater than or equal to 24 weeks of estimated gestational age
* Live Pregnancy
* States a plan to use an Intrauterine Device (IUD) postpartum for contraception
* Plan for cesarean delivery
* Intend to stay in the Chapel Hill area for at least 6 months after birth
* Fluent in English or Spanish

Exclusion Criteria:

* known uterine anomalies
* allergies to any component of the IUD of their choosing
* known or suspected carcinoma of the breast
* known acute liver disease or liver tumor (benign or malignant)
* known or suspected uterine or cervical neoplasia
* active pelvic inflammatory disease
* genital bleeding of unknown etiology
* history of solid organ transplantation
* positive test for gonorrhea or chlamydia during this pregnancy
B: 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
C: Inclusion Criteria:

* Pregnant at time of enrollment
* Planning to undergo a scheduled cesarean delivery
* Desires to use the LNG-IUS for contraception
* Willing and able to sign an informed consent in English
* Willing to comply with the study protocol
* Age greater than or equal to 18 years
* English speaking

Exclusion Criteria:

* Allergy to either polyethylene or levonorgestrel, or other contraindications to use of the LNG-IUS
* Positive testing for Gonorrhea, Chlamydia, or trichomoniasis during the pregnancy without treatment and a subsequent test of cure confirming a negative result
* Presence of leiomyomata significantly distorting the uterine cavity and thus not allowing placement of the LNG-IUS
* Uterine anomaly which would not allow placement of the LNG-IUS
* Current cervical cancer or carcinoma in-situ
* Desire for repeat pregnancy in less than 12 months
* History of postabortal or postpartum sepsis
D: Inclusion Criteria:

* Female
* 18 - 50 years old
* Voluntarily requesting contraceptive implants for postpartum contraception
* Vaginal delivery or cesarean delivery at Mulago Hospital
* Willing and able to give informed consent
* Agree to a possible home visit for follow up
* Access to a cellphone for the duration of the study

Exclusion Criteria:

* Current breast cancer or breast cancer within the past 5 years
* Decompensated cirrhosis or a liver tumor
* Unexplained vaginal bleeding prior to pregnancy
* Current (or planned) use of Efavirenz medication

Answer: B