Immediate Versus Delayed IUD Insertion After Second Trimester Medical Abortion

NCT ID: NCT03505047

Last Updated: 2020-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-10
• Study Completion Date: 2020-01-31

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.

Conditions

Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Copper Intrauterine device

Intervention Type: DEVICE

Immediate insertion of the copper intrauterine device after completion of abortion

Delayed Group

The Copper Intrauterine device will be inserted at a local community health centre 14-28 days after discharge.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Copper Intrauterine device

Immediate insertion of the copper intrauterine device after completion of abortion

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: collaborator

University of Cape Town

OTHER

Sponsor Role: lead

Responsible Party

Deborah Constant, Dr

Senior Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deborah Constant, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cape Town

Locations

Groote Schuur Hospital

Cape Town, Western Province, South Africa

Countries

South Africa

Other Identifiers

007/2018

Identifier Type: -

Identifier Source: org_study_id