ContraceptionNCT03505047
Immediate Versus Delayed IUD Insertion After Second Trimester Medical Abortion
A study testing Copper Intrauterine device in people with Contraception, run by University of Cape Town at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Contraception
- What is being tested?
- Copper Intrauterine device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSouth Africa
- Study dates
- 10 May 2018to 31 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Africa1 site
Groote Schuur Hospital
Cape Town, Western Province, 7925
About this study
Official title: 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.
- Conditions
- Contraception
- Being tested
- Copper Intrauterine device
- Keywords
- second trimester medical abortion, Immediate versus delayed insertion, copper intrauterine device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copper Intrauterine deviceDevice
Immediate insertion of the copper intrauterine device after completion of abortion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of the copper IUD
Number of women using the IUD
Measured: 6 weeks after second trimester abortion
Insertion of the IUD
Number of IUD insertions
Measured: 6 weeks after second trimester abortion
Secondary outcomes (9)
Use of the IUD at 3 months post-abortion
Number of women using the IUD
Measured: 3 months after second trimester medical abortion
Use of the IUD at 6 months post-abortion
Number of women using the IUD
Measured: 6 months after second trimester medical abortion
Spontaneous expulsion of the IUD
Number of full and partial expulsions
Measured: 6 weeks post-abortion
Spontaneous expulsion of the IUD
Number of full and partial expulsions
Measured: Between 6 weeks and 3 months post abortion
Spontaneous expulsion of the IUD
Number of full and partial expulsions
Measured: Between 3 and 6 months post abortion
Removal of IUD and associated factors
Number of removals
Measured: within 3 and 6 months post-abortion
Abortion-related and IUD-related complications
Number of complications
Measured: within 3 months post-abortion
Women's satisfaction and acceptability of the IUD
5 point scales
Measured: Reported at 3 and 6 months post-abortion
Recurrent pregnancy
Number of recurrent pregnancies
Measured: At 6 months post-abortion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start10 May 2018
- Primary completion31 Aug 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Principal investigator, Deborah Constant, Dr, University of Cape Town
- Investigators
- Deborah Constant, PhD, Principal investigator, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505047
- Sponsor's protocol ID
- 007/2018
- Status last verified
- Mar 2020
- First submitted
- 12 Apr 2018
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant data will be made available from an institutional repository
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Versus Delayed Insertion of the Copper IUD After Second-trimester Medical Abortion - a Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT03505047
- Acronym / sponsor ID
- 007/2018
- Conditions
- Contraception
- Keywords
- second trimester medical abortion, Immediate versus delayed insertion, copper intrauterine device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- 10 May 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 23 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate group: | Experimental | Device: Copper Intrauterine deviceThe 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. |
| Delayed Group | No intervention | –The Copper Intrauterine device will be inserted at a local community health centre 14-28 days after discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Copper Intrauterine deviceImmediate insertion of the copper intrauterine device after completion of abortion | Device | Immediate group: |
Primary outcome
Use of the copper IUD
Time frame: 6 weeks after second trimester abortion
Number of women using the IUD
Insertion of the IUD
Time frame: 6 weeks after second trimester abortion
Number of IUD insertions
9 secondary outcomes
Use of the IUD at 3 months post-abortion
Time frame: 3 months after second trimester medical abortion
Use of the IUD at 6 months post-abortion
Time frame: 6 months after second trimester medical abortion
Spontaneous expulsion of the IUD
Time frame: 6 weeks post-abortion
Spontaneous expulsion of the IUD
Time frame: Between 6 weeks and 3 months post abortion
Spontaneous expulsion of the IUD
Time frame: Between 3 and 6 months post abortion
Removal of IUD and associated factors
Time frame: within 3 and 6 months post-abortion
Abortion-related and IUD-related complications
Time frame: within 3 months post-abortion
Women's satisfaction and acceptability of the IUD
Time frame: Reported at 3 and 6 months post-abortion
Recurrent pregnancy
Time frame: At 6 months post-abortion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Individual participant dataSharing planned: Yes. Participant data will be made available from an institutional repository
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Constant, PhD principal investigator
University of Cape Town
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Copper Intrauterine device in people with Contraception, run by University of Cape Town at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of the copper IUD (time frame: 6 weeks after second trimester abortion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.