Please select the eligibility criteria that correspond to the clinical trial below.
Title: Immediate Post-placental Insertion of the Copper T 380A After Cesarean Delivery Versus 6 Week Post-cesarean Insertion: A Pilot Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine, in a pilot setting, if this study is feasible in terms of recruitment, willingness to be randomized, provision of contraceptive methods, and follow-up. The investigators hypothesize that this pilot study will be feasible in terms of recruitment, provision of care, and follow-up.

The study will be a pilot randomized controlled trial comparing outcomes of immediate post-placental insertion of the Copper T 380A (Group 1) to outcomes of interval insertion of the Copper T 380A performed 6 weeks after delivery (Group 2) for patients undergoing scheduled cesarean delivery at Mulago Hospital in Kampala, Uganda. This study will not be powered to detect a difference, but rather the investigators will enroll all eligible and interested women during the three-month enrollment period. Potential participants who do not choose an IUD or who choose not to participate will be offered an anonymous opt-out survey.


Options:
A: 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
B: 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
C: Inclusion Criteria:

1. Pregnant at time of enrollment
2. Scheduled to undergo non-emergent cesarean delivery
3. Will have to wait at least 8 hours before their cesarean section
4. Are not in active labor
5. Desires to use the Copper T 380A for contraception
6. Willing and able to sign an informed consent
7. Willing to comply with the study protocol
8. Age greater than or equal to 18 years
9. English or Luganda speaking
10. Willing to be accompanied home upon discharge from the hospital and have their address recorded in order to be able to visit them at home at 6 months postpartum if they do not return for their 6 month follow-up visit.

Exclusion Criteria:

1. Allergy to copper or pelvic tuberculosis, severe thrombocytopenia
2. Positive N. gonorrheae or C. trachomatis testing
3. Presence of leiomyomata significantly distorting the uterine cavity and thus not allowing placement of the Copper T 380A
4. Uterine anomaly which would not allow placement of the Copper T 380A
5. Current cervical cancer or carcinoma in-situ
6. Desire for repeat pregnancy in less than 12 months
7. Evidence of intra-uterine infection (Chorioamnionitis)
8. Pre-term birth prior to 34 weeks of gestation
9. Diagnosis of AIDS (HIV is not an exclusion criteria)
10. Fetal demise
11. Antepartum hemorrhage
12. Ruptured uterus
13. Eclampsia
14. Evidence of severe anemia

Post enrollment exclusion criteria

1. Group 1: Interval development of any of the above exclusion criteria (New evidence of chorioamnionitis; fetal demise; ruptured uterus; eclampsia; severe anemia)
2. Group 1: Post-partum hemorrhage with continued active bleeding that does not allow placement of the Copper T 380A within 10 minutes of the delivery of the placenta
3. Group 1: Prolonged rupture of membranes \> 12 hours
4. Group 2: Diagnosis of active cervical infection within 3 months of planned insertion, or evidence of active pelvic or cervical infection, pus at the cervical os or any concern for upper genital tract infection, including fever (temperature ≥ 38° C) or uterine or adnexal tenderness. Diagnosis of new pregnancy.
5. Group 2: Interval development of any of the above exclusion criteria (i.e. new suspicion of cervical cancer or carcinoma in situ)
6. Both Groups: Participant no longer desires a Copper T 380A
D: 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

Answer: C