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Immediate Versus Delayed IUD Insertion After Second Trimester Medical Abortion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03505047
Recruitment Status : Completed
First Posted : April 23, 2018
Last Update Posted : March 26, 2020
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Deborah Constant, Dr, University of Cape Town

Tracking Information
First Submitted Date  ICMJE April 12, 2018
First Posted Date  ICMJE April 23, 2018
Last Update Posted Date March 26, 2020
Actual Study Start Date  ICMJE May 10, 2018
Actual Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2019)
  • Use of the copper IUD [ Time Frame: 6 weeks after second trimester abortion ]
    Number of women using the IUD
  • Insertion of the IUD [ Time Frame: 6 weeks after second trimester abortion ]
    Number of IUD insertions
Original Primary Outcome Measures  ICMJE
 (submitted: April 12, 2018)
Insertion and use of the copper IUD [ Time Frame: 3 months after second trimester abortion ]
Number of insertions and number of women using the IUD
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2019)
  • Use of the IUD at 3 months post-abortion [ Time Frame: 3 months after second trimester medical abortion ]
    Number of women using the IUD
  • Use of the IUD at 6 months post-abortion [ Time Frame: 6 months after second trimester medical abortion ]
    Number of women using the IUD
  • Spontaneous expulsion of the IUD [ Time Frame: 6 weeks post-abortion ]
    Number of full and partial expulsions
  • Spontaneous expulsion of the IUD [ Time Frame: Between 6 weeks and 3 months post abortion ]
    Number of full and partial expulsions
  • Spontaneous expulsion of the IUD [ Time Frame: Between 3 and 6 months post abortion ]
    Number of full and partial expulsions
  • Removal of IUD and associated factors [ Time Frame: within 3 and 6 months post-abortion ]
    Number of removals
  • Abortion-related and IUD-related complications [ Time Frame: within 3 months post-abortion ]
    Number of complications
  • Women's satisfaction and acceptability of the IUD [ Time Frame: Reported at 3 and 6 months post-abortion ]
    5 point scales
  • Recurrent pregnancy [ Time Frame: At 6 months post-abortion ]
    Number of recurrent pregnancies
Original Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2018)
  • Use of the IUD at 6 months post-abortion [ Time Frame: 6 months after second trimester medical abortion ]
    Number of women using the IUD
  • Spontaneous expulsion of the IUD [ Time Frame: 6 weeks post-abortion ]
    Number of full and partial expulsions
  • Abortion-related and IUD-related complications [ Time Frame: within 3 months post-abortion ]
    Number of complications
  • Removal of IUD and associated factors [ Time Frame: within 3 and 6 months post-abortion ]
    Number of removals
  • Women's satisfaction and acceptability of the IUD [ Time Frame: Reported at 3 and 6 months post-abortion ]
    5 point scales
  • Recurrent pregnancy [ Time Frame: At 6 months post-abortion ]
    Number of recurrent pregnancies
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immediate Versus Delayed IUD Insertion After Second Trimester Medical Abortion
Official Title  ICMJE Immediate Versus Delayed Insertion of the Copper IUD After Second-trimester Medical Abortion - a Randomised Controlled Trial.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Contraception
Intervention  ICMJE Device: Copper Intrauterine device
Immediate insertion of the copper intrauterine device after completion of abortion
Study Arms  ICMJE
  • 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.
    Intervention: Device: Copper Intrauterine device
  • No Intervention: Delayed Group
    The Copper Intrauterine device will be inserted at a local community health centre 14-28 days after discharge.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 12, 2018)
110
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 31, 2020
Actual Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE South Africa
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03505047
Other Study ID Numbers  ICMJE 007/2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Participant data will be made available from an institutional repository
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data will become available following successful publication of findings - Expected date December 2020. No cut-off date
Access Criteria: Through application to lead investigator
Current Responsible Party Deborah Constant, Dr, University of Cape Town
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Cape Town
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE University of California, San Francisco
Investigators  ICMJE
Principal Investigator: Deborah Constant, PhD University of Cape Town
PRS Account University of Cape Town
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP