Immediate Post-placental Insertion of the Copper T 380A After Cesarean Delivery Versus 6 Week Post-cesarean Insertion

Planned Parenthood League of Massachusetts

Status

Completed

Conditions

Contraception

Treatments

Other: 6 weeks interval insertion

Other: Immediate insertion

Study type

Interventional

Funder types

Other

Identifiers

NCT01293760

2010p001355

Details and patient eligibility

About

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.

Enrollment

68 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Pregnant at time of enrollment
Scheduled to undergo non-emergent cesarean delivery
Will have to wait at least 8 hours before their cesarean section
Are not in active labor
Desires to use the Copper T 380A for contraception
Willing and able to sign an informed consent
Willing to comply with the study protocol
Age greater than or equal to 18 years
English or Luganda speaking
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

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

Post enrollment exclusion criteria

Group 1: Interval development of any of the above exclusion criteria (New evidence of chorioamnionitis; fetal demise; ruptured uterus; eclampsia; severe anemia)
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
Group 1: Prolonged rupture of membranes > 12 hours
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.
Group 2: Interval development of any of the above exclusion criteria (i.e. new suspicion of cervical cancer or carcinoma in situ)
Both Groups: Participant no longer desires a Copper T 380A