CompletedNot Applicable

Immediate Versus Delayed IUD Insertion After Second Trimester Medical Abortion

South Africa110 participantsStarted 2018-05-10

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Use of the copper IUD

Timeframe: 6 weeks after second trimester abortion

Insertion of the IUD

Timeframe: 6 weeks after second trimester abortion

Trial details

NCT IDNCT03505047

SponsorUniversity of Cape Town

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-08-31

View on ClinicalTrials.gov More Contraception trials