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

Study Description

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual 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
• Actual Primary Completion Date: August 31, 2019
• Actual Study Completion Date: January 31, 2020

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

South Africa

Groote Schuur Hospital

Cape Town, Western Province, South Africa, 7925

Sponsors and Collaborators

University of Cape Town

University of California, San Francisco

Investigators

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

More Information

• Responsible Party: Deborah Constant, Dr, Senior Researcher, University of Cape Town
• ClinicalTrials.gov Identifier: NCT03505047
• Other Study ID Numbers: 007/2018
• First Posted: April 23, 2018
• Last Update Posted: March 26, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Participant data will be made available from an institutional repository
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); 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

• 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:

Copper; Trace Elements; Micronutrients; Physiological Effects of Drugs