Immediate Versus Delayed IUD Insertion After Second Trimester Medical Abortion
Not Applicable
Completed
- Conditions
- Contraception
- Interventions
- Device: Copper Intrauterine device
- Registration Number
- NCT03505047
- Lead Sponsor
- University of Cape Town
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 110
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Immediate group: Copper Intrauterine device The Copper Intrauterine device will be inserted within 24 hours of the expulsion of the fetus and placenta or after surgical evacuation for placental remains, and prior to discharge from the facility.
- Primary Outcome Measures
Name Time Method Insertion of the IUD 6 weeks after second trimester abortion Number of IUD insertions
Use of the copper IUD 6 weeks after second trimester abortion Number of women using the IUD
- Secondary Outcome Measures
Name Time Method Abortion-related and IUD-related complications within 3 months post-abortion Number of complications
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
Use of the IUD at 6 months post-abortion 6 months after second trimester medical abortion Number of women using the IUD
Spontaneous expulsion of the IUD Between 3 and 6 months post abortion Number of full and partial expulsions
Use of the IUD at 3 months post-abortion 3 months after second trimester medical abortion Number of women using the IUD
Removal of IUD and associated factors within 3 and 6 months post-abortion Number of removals
Trial Locations
- Locations (1)
Groote Schuur Hospital
🇿🇦Cape Town, Western Province, South Africa