ContraceptionNCT02527278
Retrospective Claims Analysis of Hysterectomy After Sterilization
An observational study of Contraception, run by Bayer at 1 site in United States.
Trial summary
The research questions are: 1. What is the proportion of women undergoing hysterectomy after hysteroscopic sterilization or laparoscopic tubal ligation? 2. What is the proportion of women undergoing salpingectomy, salpingostomy, or hysteroscopy after hysteroscopic sterilization or laparoscopic tubal ligation? 3. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Contraception
- What is being tested?
- Laparoscopic tubal ligation and Hysteroscopic sterilization
- Type of treatment
- Surgery or procedure
- How many people
- 19,317 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2015to 9 Feb 2016
- Phase
- Observational
- 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 to 49 years
- Women only
- No healthy volunteers
- Adult
Study population: Women aged 18 - 49 at the time of the sterilization procedure from an administrative claims database
Who may be able to join
- Women aged 18 through 49 years at the index date
- at least one claim of the hysteroscopic sterilization procedure or interval laparoscopic tubal ligation at any time during January 1, 2010 -December 31, 2012
- Had 6 months of continuous medical and pharmacy benefits pre-index date which is considered the baseline period to capture all patient characteristics prior to the procedure
- Had 12 months of continuous medical and pharmacy benefits post-index date (i.e., follow-up period)
Who cannot join
- Women who underwent a postpartum tubal ligation procedure during the entire study period
- Women who had claims of a sterilization procedure during the baseline period
- Women who had a claim for pregnancy or delivery within 6 weeks prior to the index date
- Women who had more than one type of sterilization procedure (i.e., combination of hysteroscopic sterilization, laparoscopic tubal ligation or mini-laparotomy) on the same index date
- Women who had concurrent procedures on the same day as the index sterilization procedure that were performed for reasons beyond the purpose of sterilization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Claims Analysis to Calculate the Proportion of Women Undergoing Hysterectomy, Salpingectomy, Salpingostomy, Hysteroscopy or Who Had a Diagnosis of Pelvic Pain After Hysteroscopic Sterilization or Laparoscopic Tubal Ligation
The research questions are:
- What is the proportion of women undergoing hysterectomy after hysteroscopic sterilization or laparoscopic tubal ligation?
- What is the proportion of women undergoing salpingectomy, salpingostomy, or hysteroscopy after hysteroscopic sterilization or laparoscopic tubal ligation?
- What is the proportion of women who have a diagnosis of pelvic pain after hysteroscopic sterilization or laparoscopic tubal ligation?
- Conditions
- Contraception
- Being tested
- Laparoscopic tubal ligation, Hysteroscopic sterilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic tubal ligationProcedure or surgery
Female permanent birth control method performed via a surgical procedure
Hysteroscopic sterilizationProcedure or surgery
Female permanent birth control method performed via placement of a device
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic tubal ligation (no pain) | Women who have laparoscopic tubal ligation, with no previous diagnosis of pain at baseline Receives: Procedure: Laparoscopic tubal ligation | |
| Laparoscopic tubal ligation (pain) | Women who have laparoscopic tubal ligation, with a previous diagnosis of pain at baseline Receives: Procedure: Laparoscopic tubal ligation | |
| Hysteroscopic sterilization (no pain) | Women who have hysteroscopic sterilization, with no previous diagnosis of pain at baseline Receives: Procedure: Hysteroscopic sterilization | |
| Hysteroscopic sterilization (pain) | Women who have hysteroscopic sterilization, with a previous diagnosis of pain at baseline Receives: Procedure: Hysteroscopic sterilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women undergoing hysterectomy after hysteroscopic sterilization or laparoscopic tubal ligation
Measured: Within 12 months after the procedure
Secondary outcomes (4)
Proportion of women undergoing salpingectomy after hysteroscopic sterilization or laparoscopic tubal ligation
Measured: Within 12 months after the procedure
Proportion of women undergoing salpingostomy after hysteroscopic sterilization or laparoscopic tubal ligation
Measured: Within 12 months after the procedure
Proportion of women undergoing hysteroscopy after hysteroscopic sterilization or laparoscopic tubal ligation
Measured: Within 12 months after the procedure
Proportion of women who have a diagnosis of pelvic pain after hysteroscopic sterilization or laparoscopic tubal ligation
Measured: Within 12 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study start30 Jul 2015
- Primary completion9 Feb 2016
- Study completion9 Feb 2016
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.
- More trials run by BayerThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 19,317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527278
- Sponsor's protocol ID
- 18477
- Status last verified
- Mar 2017
- First submitted
- 17 Aug 2015
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Claims Analysis to Calculate the Proportion of Women Undergoing Hysterectomy, Salpingectomy, Salpingostomy, Hysteroscopy or Who Had a Diagnosis of Pelvic Pain After Hysteroscopic Sterilization or Laparoscopic Tubal Ligation
- ClinicalTrials.gov ID
- NCT02527278
- Acronym / sponsor ID
- 18477
- Conditions
- Contraception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19,317 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2015 (actual)
- Primary completion
- 9 Feb 2016 (actual)
- Study completion
- 9 Feb 2016 (actual)
- First posted
- 18 Aug 2015 (estimated)
- 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 research questions are:
- What is the proportion of women undergoing hysterectomy after hysteroscopic sterilization or laparoscopic tubal ligation?
- What is the proportion of women undergoing salpingectomy, salpingostomy, or hysteroscopy after hysteroscopic sterilization or laparoscopic tubal ligation?
- What is the proportion of women who have a diagnosis of pelvic pain after hysteroscopic sterilization or laparoscopic tubal ligation?
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic tubal ligation (no pain) | – | Procedure: Laparoscopic tubal ligationWomen who have laparoscopic tubal ligation, with no previous diagnosis of pain at baseline |
| Laparoscopic tubal ligation (pain) | – | Procedure: Laparoscopic tubal ligationWomen who have laparoscopic tubal ligation, with a previous diagnosis of pain at baseline |
| Hysteroscopic sterilization (no pain) | – | Procedure: Hysteroscopic sterilizationWomen who have hysteroscopic sterilization, with no previous diagnosis of pain at baseline |
| Hysteroscopic sterilization (pain) | – | Procedure: Hysteroscopic sterilizationWomen who have hysteroscopic sterilization, with a previous diagnosis of pain at baseline |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women aged 18 - 49 at the time of the sterilization procedure from an administrative claims database
Key inclusion criteria (4 listed)
- Women aged 18 through 49 years at the index date
- at least one claim of the hysteroscopic sterilization procedure or interval laparoscopic tubal ligation at any time during January 1, 2010 -December 31, 2012
- Had 6 months of continuous medical and pharmacy benefits pre-index date which is considered the baseline period to capture all patient characteristics prior to the procedure
- Had 12 months of continuous medical and pharmacy benefits post-index date (i.e., follow-up period)
Key exclusion criteria (5 listed)
- Women who underwent a postpartum tubal ligation procedure during the entire study period
- Women who had claims of a sterilization procedure during the baseline period
- Women who had a claim for pregnancy or delivery within 6 weeks prior to the index date
- Women who had more than one type of sterilization procedure (i.e., combination of hysteroscopic sterilization, laparoscopic tubal ligation or mini-laparotomy) on the same index date
- Women who had concurrent procedures on the same day as the index sterilization procedure that were performed for reasons beyond the purpose of sterilization
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 |
|---|---|---|
| Laparoscopic tubal ligationFemale permanent birth control method performed via a surgical procedure | Procedure or surgery | Laparoscopic tubal ligation (no pain), Laparoscopic tubal ligation (pain) |
| Hysteroscopic sterilizationFemale permanent birth control method performed via placement of a device | Procedure or surgery | Hysteroscopic sterilization (no pain), Hysteroscopic sterilization (pain) |
Primary outcome
Proportion of women undergoing hysterectomy after hysteroscopic sterilization or laparoscopic tubal ligation
Time frame: Within 12 months after the procedure
4 secondary outcomes
Proportion of women undergoing salpingectomy after hysteroscopic sterilization or laparoscopic tubal ligation
Time frame: Within 12 months after the procedure
Proportion of women undergoing salpingostomy after hysteroscopic sterilization or laparoscopic tubal ligation
Time frame: Within 12 months after the procedure
Proportion of women undergoing hysteroscopy after hysteroscopic sterilization or laparoscopic tubal ligation
Time frame: Within 12 months after the procedure
Proportion of women who have a diagnosis of pelvic pain after hysteroscopic sterilization or laparoscopic tubal ligation
Time frame: Within 12 months after the procedure
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 21 Mar 2017.
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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.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception, run by Bayer at 1 site 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 4 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 21 Mar 2017. 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 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?
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?
Proportion of women undergoing hysterectomy after hysteroscopic sterilization or laparoscopic tubal ligation (time frame: Within 12 months after the procedure). 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 21 Mar 2017.