Immediate Versus Delayed IUD Insertion After Second Trimester Medical Abortion

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

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.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Device: Copper Intrauterine device

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Western Province
    • Cape Town, Western Province, South Africa, 7925
      • Groote Schuur Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of the copper IUD	Number of women using the IUD	6 weeks after second trimester abortion
Insertion of the IUD	Number of IUD insertions	6 weeks after second trimester abortion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of the IUD at 3 months post-abortion	Number of women using the IUD	3 months after second trimester medical abortion
Use of the IUD at 6 months post-abortion	Number of women using the IUD	6 months after second trimester medical abortion
Spontaneous expulsion of the IUD	Number of full and partial expulsions	6 weeks post-abortion
Spontaneous expulsion of the IUD	Number of full and partial expulsions	Between 6 weeks and 3 months post abortion
Spontaneous expulsion of the IUD	Number of full and partial expulsions	Between 3 and 6 months post abortion
Removal of IUD and associated factors	Number of removals	within 3 and 6 months post-abortion
Abortion-related and IUD-related complications	Number of complications	within 3 months post-abortion
Women's satisfaction and acceptability of the IUD	5 point scales	Reported at 3 and 6 months post-abortion
Recurrent pregnancy	Number of recurrent pregnancies	At 6 months post-abortion

Collaborators and Investigators

• Sponsor: University of Cape Town
• Collaborators: University of California, San Francisco
• Investigators: Principal Investigator: Deborah Constant, PhD, University of Cape Town

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2018
• Primary Completion (Actual): August 31, 2019
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: April 12, 2018
• First Submitted That Met QC Criteria: April 12, 2018
• First Posted (Actual): April 23, 2018

Study Record Updates

• Last Update Posted (Actual): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 25, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: second trimester medical abortion; Immediate versus delayed insertion; copper intrauterine device
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Trace Elements; Micronutrients; Copper
• Other Study ID Numbers: 007/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Participant data will be made available from an institutional repository
• IPD Sharing Time Frame: Data will become available following successful publication of findings - Expected date December 2020. No cut-off date
• IPD Sharing Access Criteria: Through application to lead investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No