Intrauterine Device ExpulsionNCT00621543
Insertion of an Intrauterine Device (IUD) After Medical Abortion
A study testing IUD insertion [Copper T-380A or Levonorgestrel (intrauterine system) IUS] in people with Intrauterine Device Expulsion and Medical Abortion, run by Boston University at 2 sites in United States.
Trial summary
The purpose of this study is to determine the expulsion and continuation rate of an intruterine device (IUD) placed immediately after medical abortion. Our hypothesis is that immediate-placement of an IUD after completed medical abortion will have a similar expulsion and continuation rate to traditional placement (4-6… Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Intrauterine Device Expulsion, Medical Abortion, Induced Abortion
- What is being tested?
- IUD insertion [Copper T-380A or Levonorgestrel (intrauterine system) IUS]
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2006to Sep 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women who completed a medical abortion in the last 14 days
- At least 18 years old.
- Desiring long-term contraception with an IUD.
- Able and willing to give consent for participation in research.
- Gonorrhea and chlamydia screen negative within 60 days of entry to study.
- Willing to comply with the study requirements.
- Accessible by telephone.
Who cannot join
- Had pelvic inflammatory disease or a septic abortion within the past 3 months or gonorrheal or chlamydial infection in the last 60 days.
- Allergy to copper, or Wilson's disease (for Paragard; may have Mirena)
- Intracavitary of symptomatic uterine fibroids.
- Ovarian, cervical or endometrial cancer.
- Severe anemia (defined as hgb < 8).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston Medical Center
Boston, Massachusetts, 02118
University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: Insertion of an IUD After Medical Abortion
The purpose of this study is to determine the expulsion and continuation rate of an intruterine device (IUD) placed immediately after medical abortion.
Our hypothesis is that immediate-placement of an IUD after completed medical abortion will have a similar expulsion and continuation rate to traditional placement (4-6 weeks after pregnancy).
Read the detailed description
Women who seek abortion care often desire more effective or longer- lasting contraception. Intrauterine devices are as efficacious as tubal ligation, require no on-going effort on the woman's part to protect her from pregnancy, and are underutilized in the US. We are interested in determining whether placement of an intreatuereine device (IUD) at the time of confirming the completion of a medical abortion may have similar expulsion and continuation rates as IUDs placed after pregnancy (usually a 4-6 week time period). If this is the case, women may save the time and effort of yet another clinic visit, as well as have immediate protection against pregnancy after their abortion. FDA labeling does not specify or restrict time of insertion and therefore this study is in compliance with FDA labeling.
- Being tested
- IUD insertion [Copper T-380A or Levonorgestrel (intrauterine system) IUS]
- Keywords
- Intrauterine Device, Induced Abortion, Medical Abortion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IUD insertion [Copper T-380A or Levonorgestrel (intrauterine system) IUS]Device
Also called IUD insertion icludes the insertion of either the Copper T-380A or Levonorgestrel (intrauterine system) IUS
When a subject has chosen a method of intra-uterine contraception and has agreed to participate in the study, she will have the intra-uterine device of her choice inserted according to the Food and Druga Administration (FDA) instructions.
| Study group | Role | What they receive |
|---|---|---|
| Observation- All subjects | Experimental | Women choosing intra-uterine contraception after medical abortion. Receives: Device: IUD insertion [Copper T-380A or Levonorgestrel (intrauterine system) IUS] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Women With Expulsion of an Intrauterine Device (IUD) Placed After Medical Abortion.
Measured: Three months
Secondary outcomes (1)
Percentage of Women Continuing IUD Use at 3 Months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startMar 2006
- Primary completionMay 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Intrauterine Device ExpulsionStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah
- Investigators
- Sarah J Betstadt, MD, Principal investigator, Boston UniversityLynn Borgatta, MD, MPH, Study director, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00621543
- Sponsor's protocol ID
- H-24902
- Other IDs
- H-24902
- Status last verified
- Jul 2011
- First submitted
- 28 Jan 2008
- Last updated
- 14 Jul 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Henshaw SK, Kost K. Abortion patients in 1994-1995: characteristics and contraceptive use. Fam Plann Perspect. 1996 Jul-Aug;28(4):140-7, 158.
PubMed 8853278Hubacher D, Cheng D. Intrauterine devices and reproductive health: American women in feast and famine. Contraception. 2004 Jun;69(6):437-46. doi: 10.1016/j.contraception.2004.01.009.
PubMed 15157788Kaunitz AM. Beyond the pill: new data and options in hormonal and intrauterine contraception. Am J Obstet Gynecol. 2005 Apr;192(4):998-1004. doi: 10.1016/j.ajog.2004.12.091.
PubMed 15846172Hubacher D, Lara-Ricalde R, Taylor DJ, Guerra-Infante F, Guzman-Rodriguez R. Use of copper intrauterine devices and the risk of tubal infertility among nulligravid women. N Engl J Med. 2001 Aug 23;345(8):561-7. doi: 10.1056/NEJMoa010438.
PubMed 11529209Penney G, Brechin S, de Souza A, Bankowska U, Belfield T, Gormley M, Olliver M, Hampton N, Howlett-Shipley R, Hughes S, Mack N, O'Brien P, Rowlands S, Trewinnard K; Faculty of Family Planning and Reproductive Health Care Clinical Effectiveness Unit. FFPRHC Guidance (January 2004). The copper intrauterine device as long-term contraception. J Fam Plann Reprod Health Care. 2004 Jan;30(1):29-41; quiz 42. doi: 10.1783/147118904322701956.
PubMed 15006311El-Tagy A, Sakr E, Sokal DC, Issa AH. Safety and acceptability of post-abortal IUD insertion and the importance of counseling. Contraception. 2003 Mar;67(3):229-34. doi: 10.1016/s0010-7824(02)00518-8.
PubMed 12618259Stanwood NL, Grimes DA, Schulz KF. Insertion of an intrauterine contraceptive device after induced or spontaneous abortion: a review of the evidence. BJOG. 2001 Nov;108(11):1168-73. doi: 10.1111/j.1471-0528.2003.00264.x.
PubMed 11762657Christin-Maitre S, Bouchard P, Spitz IM. Medical termination of pregnancy. N Engl J Med. 2000 Mar 30;342(13):946-56. doi: 10.1056/NEJM200003303421307.
PubMed 10738054
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insertion of an IUD After Medical Abortion
- ClinicalTrials.gov ID
- NCT00621543
- Acronym / sponsor ID
- H-24902
- Keywords
- Intrauterine Device, Induced Abortion, Medical Abortion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- University of Utah
- Study start
- Mar 2006
- Primary completion
- May 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 22 Feb 2008 (estimated)
- Results
- Posted 8 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the expulsion and continuation rate of an intruterine device (IUD) placed immediately after medical abortion.
Our hypothesis is that immediate-placement of an IUD after completed medical abortion will have a similar expulsion and continuation rate to traditional placement (4-6 weeks after pregnancy).
Detailed description
Women who seek abortion care often desire more effective or longer- lasting contraception. Intrauterine devices are as efficacious as tubal ligation, require no on-going effort on the woman's part to protect her from pregnancy, and are underutilized in the US. We are interested in determining whether placement of an intreatuereine device (IUD) at the time of confirming the completion of a medical abortion may have similar expulsion and continuation rates as IUDs placed after pregnancy (usually a 4-6 week time period). If this is the case, women may save the time and effort of yet another clinic visit, as well as have immediate protection against pregnancy after their abortion. FDA labeling does not specify or restrict time of insertion and therefore this study is in compliance with FDA labeling.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation- All subjects | Experimental | Device: IUD insertion [Copper T-380A or Levonorgestrel (intrauterine system) IUS]Women choosing intra-uterine contraception after medical abortion. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women who completed a medical abortion in the last 14 days
- At least 18 years old.
- Desiring long-term contraception with an IUD.
- Able and willing to give consent for participation in research.
- Gonorrhea and chlamydia screen negative within 60 days of entry to study.
Key exclusion criteria (5 listed)
- Had pelvic inflammatory disease or a septic abortion within the past 3 months or gonorrheal or chlamydial infection in the last 60 days.
- Allergy to copper, or Wilson's disease (for Paragard; may have Mirena)
- Intracavitary of symptomatic uterine fibroids.
- Ovarian, cervical or endometrial cancer.
- Severe anemia (defined as hgb < 8).
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 |
|---|---|---|
| IUD insertion [Copper T-380A or Levonorgestrel (intrauterine system) IUS]Also: IUD insertion icludes the insertion of either the Copper T-380A or Levonorgestrel (intrauterine system) IUSWhen a subject has chosen a method of intra-uterine contraception and has agreed to participate in the study, she will have the intra-uterine device of her choice inserted according to the Food and Druga Administration (FDA) instructions. | Device | Observation- All subjects |
Primary outcome
Percentage of Women With Expulsion of an Intrauterine Device (IUD) Placed After Medical Abortion.
Time frame: Three months
1 secondary outcome
Percentage of Women Continuing IUD Use at 3 Months
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8853278Henshaw SK, Kost K. Abortion patients in 1994-1995: characteristics and contraceptive use. Fam Plann Perspect. 1996 Jul-Aug;28(4):140-7, 158.
- Background: PubMed 15157788Hubacher D, Cheng D. Intrauterine devices and reproductive health: American women in feast and famine. Contraception. 2004 Jun;69(6):437-46. doi: 10.1016/j.contraception.2004.01.009.
- Background: PubMed 15846172Kaunitz AM. Beyond the pill: new data and options in hormonal and intrauterine contraception. Am J Obstet Gynecol. 2005 Apr;192(4):998-1004. doi: 10.1016/j.ajog.2004.12.091.
- Background: PubMed 11529209Hubacher D, Lara-Ricalde R, Taylor DJ, Guerra-Infante F, Guzman-Rodriguez R. Use of copper intrauterine devices and the risk of tubal infertility among nulligravid women. N Engl J Med. 2001 Aug 23;345(8):561-7. doi: 10.1056/NEJMoa010438.
- Background: PubMed 15006311Penney G, Brechin S, de Souza A, Bankowska U, Belfield T, Gormley M, Olliver M, Hampton N, Howlett-Shipley R, Hughes S, Mack N, O'Brien P, Rowlands S, Trewinnard K; Faculty of Family Planning and Reproductive Health Care Clinical Effectiveness Unit. FFPRHC Guidance (January 2004). The copper intrauterine device as long-term contraception. J Fam Plann Reprod Health Care. 2004 Jan;30(1):29-41; quiz 42. doi: 10.1783/147118904322701956.
- Background: PubMed 12618259El-Tagy A, Sakr E, Sokal DC, Issa AH. Safety and acceptability of post-abortal IUD insertion and the importance of counseling. Contraception. 2003 Mar;67(3):229-34. doi: 10.1016/s0010-7824(02)00518-8.
- Background: PubMed 11762657Stanwood NL, Grimes DA, Schulz KF. Insertion of an intrauterine contraceptive device after induced or spontaneous abortion: a review of the evidence. BJOG. 2001 Nov;108(11):1168-73. doi: 10.1111/j.1471-0528.2003.00264.x.
- Background: PubMed 10738054Christin-Maitre S, Bouchard P, Spitz IM. Medical termination of pregnancy. N Engl J Med. 2000 Mar 30;342(13):946-56. doi: 10.1056/NEJM200003303421307.
- Intrauterine Devices. The Mayo ClinicLink provided by the sponsor.
Related trials for Intrauterine Device Expulsion
Recruiting
Pilot Study of Suction as a Mechanism of IUD Expulsion With Concomitant Menstrual Cup Use
IUD; Complications, Mechanical, Menstrual Cup
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.
Sarah J Betstadt, MD principal investigator
Boston University
Lynn Borgatta, MD, MPH study director
Boston University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IUD insertion [Copper T-380A or Levonorgestrel (intrauterine system) IUS] in people with Intrauterine Device Expulsion and Medical Abortion, run by Boston University at 2 sites in United States.
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 7 inclusion and 5 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 14 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 8 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Women With Expulsion of an Intrauterine Device (IUD) Placed After Medical Abortion. (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00621543, which also lists 8 linked publications.
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 14 Jul 2011.