Immediate Post-placental Insertion of the Copper T 380A After Cesarean Delivery Versus 6 Week Post-cesarean Insertion: A Pilot Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Contraception
- Sponsor
- Planned Parenthood League of Massachusetts
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- 6 month IUD usage rates
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
6 month IUD usage rates
Time Frame: 6 months
The number of participants enrolled who are using the Copper T 380A at 6 months post-delivery. This will include participants who are excluded at time of delivery or interval insertion and participants who do not follow up for interval Copper T 380A insertion
Secondary Outcomes
- IUD Expulsion(within 6 months)
- IUD Removal(within six months)
- IUD insertion(within 6 months)
- Pregnancy(within 6 months)
- Infection(within 6 months)
- Uterine Perforation(within 6 months)