Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Pilot Study Of A Randomized Trial Comparing Two Different Time Frames For Copper T380A Intrauterine Contraception Insertion; Immediately Postpartum Compared To 4-6 Weeks Postpartum In Lilongwe, Malawi
Brief Summary: The purpose of this non-blinded randomized clinical trial is to pilot the design of a randomized clinical trial to be conducted in Malawi to investigate immediate postpartum insertion of the Copper T380 intrauterine contraceptive device (CuT380A-IUCD) compared to placement at the 6-week postpartum visit.

The investigators hypothesize that it will be feasible to enroll 140 women into this study, and that women will find the 10 minute to 48 hour time frame for IUCD placement acceptable.


Options:
A: Inclusion Criteria:

* Females desiring contraception by using intrauterine device following their vaginal delivery or cesarean section

Exclusion Criteria:

* refusal to participate in the study
* desiring other methods of contraception
* will not use any method of contraception
* has a contraindication for the use of IUD as bicornuate or septate uterus, sub mucous myomas, etc.
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:

* 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:

* 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