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Immediate Versus Delayed IUD Insertion After Second Trimester Medical Abortion

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ClinicalTrials.gov Identifier: NCT03505047
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : February 18, 2019
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Deborah Constant, Dr, 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.

Condition or disease Intervention/treatment Phase
Contraception Device: Copper Intrauterine device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immediate Versus Delayed Insertion of the Copper IUD After Second-trimester Medical Abortion - a Randomised Controlled Trial.
Actual Study Start Date : May 10, 2018
Estimated Primary Completion Date : October 15, 2019
Estimated Study Completion Date : December 15, 2019

Arm Intervention/treatment
Experimental: Immediate group:
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.
Device: Copper Intrauterine device
Immediate insertion of the copper intrauterine device after completion of abortion

No Intervention: Delayed Group
The Copper Intrauterine device will be inserted at a local community health centre 14-28 days after discharge.



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505047


Contacts
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Contact: Deborah Constant, PhD +27722527415 deborah.constant@uct.ac.za

Locations
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South Africa
Groote Schuur Hospital Recruiting
Cape Town, Western Province, South Africa, 7925
Contact: Dr M Patel, FCOG(SA)    + 27 83 263 0389    mpatel@uct.ac.za   
Sponsors and Collaborators
University of Cape Town
University of California, San Francisco
Investigators
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Principal Investigator: Deborah Constant, PhD University of Cape Town

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Responsible Party: Deborah Constant, Dr, Senior Researcher, University of Cape Town
ClinicalTrials.gov Identifier: NCT03505047     History of Changes
Other Study ID Numbers: 007/2018
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Deborah Constant, Dr, University of Cape Town:
second trimester medical abortion
Immediate versus delayed insertion
copper intrauterine device

Additional relevant MeSH terms:
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Copper
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs