Please select the eligibility criteria that correspond to the clinical trial below.
Title: Immediate Versus Interval Postpartum Use of the Levonorgestrel Contraceptive Implants: a Randomized Controlled Trial
Brief Summary: This study will evaluate if immediate postpartum placement of a levonorgestrel (LNG) contraceptive implant within 5 days of delivery improves implant utilization at 6 months postpartum compared to implant placement at 6-8 weeks postpartum among women in Uganda.


Options:
A: 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
B: 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
C: 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
D: 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

Answer: B