Immediate Versus Delayed Insertion of the Copper IUD After Second-trimester Medical Abortion - a Randomised Controlled Trial.

University of Cape Town1 site in 1 country110 target enrollmentMay 10, 2018

ConditionsContraception

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Contraception
Sponsor: University of Cape Town
Enrollment: 110
Locations: 1
Primary Endpoint: Insertion of the IUD
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 10, 2018

End Date

January 31, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

University of Cape Town

Responsible Party

Principal Investigator

Deborah Constant, Dr

Senior Researcher

University of Cape Town

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

Outcomes

Primary Outcomes

Insertion of the IUD

Time Frame: 6 weeks after second trimester abortion

Number of IUD insertions

Use of the copper IUD

Time Frame: 6 weeks after second trimester abortion

Number of women using the IUD

Secondary Outcomes

Women's satisfaction and acceptability of the IUD(Reported at 3 and 6 months post-abortion)
Recurrent pregnancy(At 6 months post-abortion)
Use of the IUD at 6 months post-abortion(6 months after second trimester medical abortion)
Spontaneous expulsion of the IUD(Between 3 and 6 months post abortion)
Use of the IUD at 3 months post-abortion(3 months after second trimester medical abortion)
Removal of IUD and associated factors(within 3 and 6 months post-abortion)
Abortion-related and IUD-related complications(within 3 months post-abortion)