Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT01293760
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01293760
Study Brief:
Protocol Section:
NCT01293760