Immediate Versus Delayed IUD Insertion After Second Trimester Medical Abortion

• ClinicalTrials.gov Identifier: NCT03505047
• Recruitment Status: Completed
• First Posted: April 23, 2018
• Last Update Posted: March 26, 2020
• Sponsor: University of Cape Town
• Collaborator: University of California, San Francisco
• Information provided by (Responsible Party): Deborah Constant, Dr, University of Cape Town

Tracking Information

• First Submitted Date: April 12, 2018
• First Posted Date: April 23, 2018
• Last Update Posted Date: March 26, 2020
• Actual Study Start Date: May 10, 2018
• Actual Primary Completion Date: August 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

Current Secondary Outcome Measures (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 (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: Immediate Versus Delayed IUD Insertion After Second Trimester Medical Abortion
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Contraception

Intervention

Device: Copper Intrauterine device

Immediate insertion of the copper intrauterine device after completion of abortion

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 12, 2018): 110
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: January 31, 2020
• Actual Primary Completion Date: August 31, 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: South Africa

Administrative Information

• NCT Number: NCT03505047
• Other Study ID Numbers: 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

• 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: University of Cape Town
• Original Study Sponsor: Same as current
• Collaborators: University of California, San Francisco

Investigators

• Principal Investigator: Deborah Constant, PhD; University of Cape Town

• PRS Account: University of Cape Town
• Verification Date: March 2020