Immediate Versus Delayed IUD Insertion After Second Trimester Medical Abortion

University of Cape Town (UCT)

Status: Completed

Conditions: Contraception

Treatments: Device: Copper Intrauterine device

Study type: Interventional

Funder types: Other

Identifiers

NCT03505047

007/2018

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

110 participants in 2 patient groups

Immediate group:

Experimental group

Description:

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.

Treatment:

Device: Copper Intrauterine device

Delayed Group

No Intervention group

Description:

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