Contraception
Conditions
Keywords
intrauterine device, contraception
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.
Interventions
OTHERImmediate insertion
Insertion of Copper T 380A immediately after c-section delivery of baby and placenta
OTHER6 weeks interval insertion
Insertion of Copper T 380A 6 weeks after c-section delivery of baby and placenta
Sponsors
Mulago Hospital, Uganda
Brigham and Women's Hospital
Society of Family Planning
Planned Parenthood League of Massachusetts
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6 month IUD usage rates | 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
| Measure | Time frame | Description |
|---|---|---|
| IUD Removal | within six months | The proportion of participants who have the Copper T 380A inserted and who deliberately have it removed. We will also analyze the time to removal for these participants |
| IUD insertion | within 6 months | The proportion of participants receiving a Copper T 380A in each group |
| IUD Expulsion | within 6 months | The time until expulsion of the Copper T 380A will be defined as the time from insertion until expulsion occurred, if known. If the date of expulsion is not known, this will be documented as the day after the IUD was last known to be in place. If a pregnancy is detected and the Copper T 380A is absent (and the participant was unaware of expulsion), the expulsion will be assumed to have occurred at the time of conception, as determined by gestational age on ultrasound. Expulsions will be measured as total expulsions and separately noted whether complete or partial |
| Infection | within 6 months | The diagnosis of PID will be made based on the 2006 CDC guidelines and the criteria used in the PEACH study |
| Uterine Perforation | within 6 months | The diagnosis of a perforation may be made by a transvaginal sonogram that shows no Copper T 380A within the uterus and an abdominal radiograph that shows a Copper T 380A within the abdominal cavity |
| Pregnancy | within 6 months | Time to pregnancy will be calculated from the date of delivery until the estimated date of conception of a subsequent pregnancy, as based on sonographic dating. If sonographic dating is not available, the date of the last missed menses or three weeks before the first positive urine pregnancy test (if amenorrheic or oligomenorrheic) will be used |
Countries
Uganda
Outcome results
None listed