Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Trial of Postplacental or Delayed Insertion of the Levonorgestrel-releasing Intrauterine Device After Vaginal Delivery
Brief Summary: This study is a randomized controlled trial comparing 6 month usage rates of the levonorgestrel-releasing intrauterine device (LNG-IUD) when inserted postplacentally after vaginal delivery or delayed placement at 6-8 weeks postpartum. Given the high rate of unintended pregnancy in the United States, particularly in postpartum women, there is a need for reliable, effective, long-term contraception such as the IUD in postpartum women. Postplacental insertion of intrauterine contraception would help to address this need. The primary hypothesis of this study is that use of the LNG-IUD at 6 months after vaginal delivery will be higher in women who have immediate postplacental insertion as compared to delayed insertion 6-8 weeks following delivery.


Options:
A: 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
B: 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
C: Inclusion Criteria:

* Age greater than or equal to 18 years
* Greater than or equal to 24 0/7 weeks pregnant at time of enrollment
* Anticipates undergoing a vaginal delivery
* Desires to use the LNG-IUD (Mirena) for postpartum contraception
* Willing and able to sign an informed consent in English
* Willing to comply with the study protocol

Exclusion Criteria:

* Planning to undergo a scheduled cesarean section
* Allergy to either polyethylene or levonorgestrel or other contraindications to use of the LNG-IUD
* Exposure to or treatment for gonorrhea, chlamydia, or trichomoniasis during the pregnancy
* Presence of one or more leiomyomata greater than 3 centimeters in diameter
* Uterine anomaly (other than a repaired septate uterus)
* Current cervical cancer or carcinoma in-situ
* Desires repeat pregnancy within one year of delivery
D: Inclusion Criteria:

* Primary Inclusion Criteria:

  * Ages 18-45 attending prenatal care
  * Greater than 34 weeks estimated gestational age
  * Desire to use the CuT380A-IUCD for contraception postpartum
  * Plan to stay in the area for at least 5 months postpartum
  * If HIV+ the women must be WHO Clinical Stage 1 or 2, or known to be clinically well on antiretroviral therapy as documented in their health passport
  * No prior cesarean delivery
  * No treatment for pelvic inflammatory disease within 3 months prior to pregnancy
  * No known uterine anomalies
  * No known pelvic tuberculosis
  * No known genital tract cancer
  * No known allergy to copper
  * No known history of ectopic pregnancy within 3 months prior to pregnancy.
  * No evidence of clinical anemia as assessed by a clinician at enrollment
  * Any other condition a clinician feels should preclude the woman from receiving the IUCD 10-minutes to 48 hours after delivery

Secondary Eligibility Criteria

* Vaginal delivery within the last 48 hours
* No postpartum hemorrhage documented by the delivering clinician
* Not known to have ruptured membranes for greater than 24 hours prior to delivery
* No infection diagnosed by a clinician
* No fever of greater than 38° during labour or delivery
* Any other condition which a clinician feels precludes the woman from receiving the IUCD 10 minutes to 48 hours after delivery.

Exclusion Criteria:

* prior cesarean section
* fever during labor and delivery
* AIDS, not well on antiretroviral therapy
* genital tuberculosis
* known uterine abnormalities or genital tract cancer
* history of ectopic pregnancy within 3 months of current pregnancy

Answer: C