Contraception
Conditions
Keywords
second trimester medical abortion, Immediate versus delayed insertion, copper intrauterine device
Brief summary
The main objective of the study is to compare use, in a randomised controlled trial, of the the copper IUD if inserted immediately after completion of a second trimester medical abortion, to standard care with insertion 3-4 or more weeks after abortion at community health centres.
Interventions
Immediate insertion of the copper intrauterine device after completion of abortion
Sponsors
University of California, San Francisco
University of Cape Town
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to speak English, Afrikaans or Xhosa; * Requesting and eligible for abortion according to standard practice at the hospital; * Gestational age 13-20 weeks verified by ultrasound; * Interested and eligible for the copper IUD as a post-abortion contraceptive method; * Willingness to participate in the trial including follow-up; * Able to provide a working phone & telephone number to allow for contact; * Willing and able to provide informed consent * Staying within one hour travel time of GSH
Exclusion criteria
* Active pelvic inflammatory disease, pelvic tuberculosis; severe thrombocytopenia; * Positive N. Gonorrhea or C. Trachomatis that has not been adequately treated * Copper allergy * Hb \<10g/dL * Uterine anomaly preventing placement of the IUD; cervical cancer or carcinoma in-situ, untreated high grade squamous intraepithelial lesions * Hemorrhage; or ruptured uterus * History of ectopic pregnancy * Wilsons' disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Use of the copper IUD | 6 weeks after second trimester abortion | Number of women using the IUD |
| Insertion of the IUD | 6 weeks after second trimester abortion | Number of IUD insertions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spontaneous expulsion of the IUD | 6 weeks post-abortion | Number of full and partial expulsions |
| Removal of IUD and associated factors | within 3 and 6 months post-abortion | Number of removals |
| Use of the IUD at 3 months post-abortion | 3 months after second trimester medical abortion | Number of women using the IUD |
| Women's satisfaction and acceptability of the IUD | Reported at 3 and 6 months post-abortion | 5 point scales |
| Recurrent pregnancy | At 6 months post-abortion | Number of recurrent pregnancies |
| Abortion-related and IUD-related complications | within 3 months post-abortion | Number of complications |
| Use of the IUD at 6 months post-abortion | 6 months after second trimester medical abortion | Number of women using the IUD |
Countries
South Africa
Outcome results
None listed