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Completed

NCT Number: NCT03505047

Immediate Versus Delayed IUD Insertion After Second Trimester Medical Abortion

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.

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Key information

Conditions

Contraception

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Groote Schuur Hospital

Cape Town, Western Province, 7925, South Africa

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Copper Intrauterine Device

Device

Immediate insertion of the copper intrauterine device after completion of abortion

Primary outcomes

  1. Use of the copper IUD

    Time frame: 6 weeks after second trimester abortion

    Number of women using the IUD

  2. Insertion of the IUD

    Time frame: 6 weeks after second trimester abortion

    Number of IUD insertions

Secondary outcomes

  1. Use of the IUD at 3 months post-abortion

    Time frame: 3 months after second trimester medical abortion

    Number of women using the IUD

  2. Use of the IUD at 6 months post-abortion

    Time frame: 6 months after second trimester medical abortion

    Number of women using the IUD

  3. Spontaneous expulsion of the IUD

    Time frame: 6 weeks post-abortion

    Number of full and partial expulsions

  4. Spontaneous expulsion of the IUD

    Time frame: Between 6 weeks and 3 months post abortion

    Number of full and partial expulsions

  5. Spontaneous expulsion of the IUD

    Time frame: Between 3 and 6 months post abortion

    Number of full and partial expulsions

  6. Removal of IUD and associated factors

    Time frame: within 3 and 6 months post-abortion

    Number of removals

  7. Abortion-related and IUD-related complications

    Time frame: within 3 months post-abortion

    Number of complications

  8. Women's satisfaction and acceptability of the IUD

    Time frame: Reported at 3 and 6 months post-abortion

    5 point scales

  9. Recurrent pregnancy

    Time frame: At 6 months post-abortion

    Number of recurrent pregnancies

Sponsors and collaborators

Lead sponsor

University of Cape Town

Other

Collaborators

  • University of California, San Francisco

Registry information

Official study title

Immediate Versus Delayed Insertion of the Copper IUD After Second-trimester Medical Abortion - a Randomised Controlled Trial.

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Apr 23, 2018
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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