NCT03505047

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 23, 2018

Completed
17 days until next milestone

Study Start

First participant enrolled

May 10, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

1.3 years

First QC Date

April 12, 2018

Last Update Submit

March 25, 2020

Conditions

Contraception

Keywords

second trimester medical abortionImmediate versus delayed insertioncopper intrauterine device

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (9)

  • Use of the IUD at 3 months post-abortion

    3 months after second trimester medical abortion

  • Use of the IUD at 6 months post-abortion

    6 months after second trimester medical abortion

  • Spontaneous expulsion of the IUD

    6 weeks post-abortion

  • Spontaneous expulsion of the IUD

    Between 6 weeks and 3 months post abortion

  • Spontaneous expulsion of the IUD

    Between 3 and 6 months post abortion

  • +4 more secondary outcomes

Study Arms (2)

Immediate group:

EXPERIMENTAL

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

Delayed Group

NO INTERVENTION

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

Interventions

Copper Intrauterine deviceDEVICE

Immediate insertion of the copper intrauterine device after completion of abortion

Immediate group:

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groote Schuur Hospital

Cape Town, Western Province, 7925, South Africa

Location

MeSH Terms

Interventions

Intrauterine Devices, Copper

Intervention Hierarchy (Ancestors)

Intrauterine Devices, MedicatedIntrauterine DevicesContraceptive Devices, FemaleContraceptive DevicesEquipment and Supplies

Study Officials

  • Deborah Constant, PhD

    University of Cape Town

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher

Study Record Dates

First Submitted

April 12, 2018

First Posted

April 23, 2018

Study Start

May 10, 2018

Primary Completion

August 31, 2019

Study Completion

January 31, 2020

Last Updated

March 26, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

Participant data will be made available from an institutional repository

Shared Documents
STUDY PROTOCOL, SAP, ICF, 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

Locations

ZA(1)