Immediate Versus Delayed IUD Insertion After Second Trimester Medical Abortion
Not Applicable
Completed
- Conditions
- Contraception
- 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
- 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
Groote Schuur Hospital🇿🇦Cape Town, Western Province, South Africa