Method of Tubal Ligation at the Time of Cesarean SectionNCT03028623
Standard Tubal Ligation Versus Salpingectomy for Sterilization at the Time of Cesarean Delivery
A study testing Salpingectomy and Tubal ligation in people with Method of Tubal Ligation at the Time of Cesarean Section, run by University of Virginia at 1 site in United States.
Trial summary
The objective of this study is to evaluate the feasibility and safety of salpingectomy versus standard tubal ligation in women undergoing surgical sterilization at the time of a planned cesarean delivery. Salpingectomy is currently being investigated as a potential strategy for ovarian cancer prevention. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Method of Tubal Ligation at the Time of Cesarean Section
- What is being tested?
- Salpingectomy and Tubal ligation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 5 Mar 2018
- 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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must have planned cesarean delivery and desire sterilization
- Subjects must be able to read and provide written informed consent
- Subjects must be English or Spanish speaking
Who cannot join
- Subjects with known hereditary cancer syndromes
- Subjects with a history of prior tubal surgery
- Subjects with a placenta accreta
- Subjects undergoing trial of labor after cesarean delivery
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: A Randomized Controlled Trial of Standard Tubal Ligation Versus Salpingectomy for Sterilization at the Time of Cesarean Delivery
The objective of this study is to evaluate the feasibility and safety of salpingectomy versus standard tubal ligation in women undergoing surgical sterilization at the time of a planned cesarean delivery. Salpingectomy is currently being investigated as a potential strategy for ovarian cancer prevention. While this procedure is currently performed during hysterectomies, its feasibility at the time of cesarean delivery is not well established.
This randomized, prospective clinical trial will compare the two sterilization methods to demonstrate that salpingectomy compared with standard tubal ligation at the time of cesarean delivery will not result in increased operative time, blood loss or other complications. This study is necessary to promote salpingectomy as a standard sterilization method during cesarean deliveries.
- Being tested
- Salpingectomy, Tubal ligation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalpingectomyProcedure or surgery
Bilateral salpingectomy will be performed instead of standard tubal ligation as sterilization during cesarean section.
Tubal ligationProcedure or surgery
Standard tubal ligation by either Parkland or Pomeroy technique will be performed at cesarean section
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Tubal sterilization will be performed by standard tubal ligation, either Parkland or Pomeroy technique, at the time of cesarean section Receives: Procedure: Tubal ligation |
| Experimental | Experimental | Tubal sterilization will be performed by bilateral salpingectomy using a ligasure device at the time of cesarean section. Receives: Procedure: Salpingectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of tubal ligation
Primary outcome will be the time it takes to complete the sterilization procedure
Measured: at time of procedure
Secondary outcomes (3)
Total procedure time
The total time it takes to complete the cesarean plus sterilization procedure
Measured: at time of procedure
Estimated blood loss
Estimated blood loss for the entire procedure
Measured: at time of procedure
Rate of aborted procedures
Inability to complete bilateral salpingectomy in the experimental arm
Measured: at time of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start1 May 2017
- Primary completion5 Mar 2018
- Study completion5 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Method of Tubal Ligation at the Time of Cesarean SectionStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kate Pettit, MD, University of Virginia
- Investigators
- Kate' Pettit, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028623
- Sponsor's protocol ID
- 19517
- Status last verified
- Apr 2018
- First submitted
- 13 Jan 2017
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garcia C, Moskowitz OM, Chisholm CA, Duska LR, Warren AL, Lyons GR, Pettit KE. Salpingectomy Compared With Tubal Ligation at Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jul;132(1):29-34. doi: 10.1097/AOG.0000000000002674.
PubMed 29889755
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Standard Tubal Ligation Versus Salpingectomy for Sterilization at the Time of Cesarean Delivery
- ClinicalTrials.gov ID
- NCT03028623
- Acronym / sponsor ID
- 19517
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 5 Mar 2018 (actual)
- Study completion
- 5 Mar 2018 (actual)
- First posted
- 23 Jan 2017 (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 objective of this study is to evaluate the feasibility and safety of salpingectomy versus standard tubal ligation in women undergoing surgical sterilization at the time of a planned cesarean delivery. Salpingectomy is currently being investigated as a potential strategy for ovarian cancer prevention. While this procedure is currently performed during hysterectomies, its feasibility at the time of cesarean delivery is not well established.
This randomized, prospective clinical trial will compare the two sterilization methods to demonstrate that salpingectomy compared with standard tubal ligation at the time of cesarean delivery will not result in increased operative time, blood loss or other complications. This study is necessary to promote salpingectomy as a standard sterilization method during cesarean deliveries.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Procedure: Tubal ligationTubal sterilization will be performed by standard tubal ligation, either Parkland or Pomeroy technique, at the time of cesarean section |
| Experimental | Experimental | Procedure: SalpingectomyTubal sterilization will be performed by bilateral salpingectomy using a ligasure device at the time of cesarean section. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects must have planned cesarean delivery and desire sterilization
- Subjects must be able to read and provide written informed consent
- Subjects must be English or Spanish speaking
Key exclusion criteria (4 listed)
- Subjects with known hereditary cancer syndromes
- Subjects with a history of prior tubal surgery
- Subjects with a placenta accreta
- Subjects undergoing trial of labor after cesarean delivery
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 |
|---|---|---|
| SalpingectomyBilateral salpingectomy will be performed instead of standard tubal ligation as sterilization during cesarean section. | Procedure or surgery | Experimental |
| Tubal ligationStandard tubal ligation by either Parkland or Pomeroy technique will be performed at cesarean section | Procedure or surgery | Control |
Primary outcome
Time of tubal ligation
Time frame: at time of procedure
Primary outcome will be the time it takes to complete the sterilization procedure
3 secondary outcomes
Total procedure time
Time frame: at time of procedure
Estimated blood loss
Time frame: at time of procedure
Rate of aborted procedures
Time frame: at time of 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 10 Apr 2018.
- Derived from this study: PubMed 29889755Garcia C, Moskowitz OM, Chisholm CA, Duska LR, Warren AL, Lyons GR, Pettit KE. Salpingectomy Compared With Tubal Ligation at Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jul;132(1):29-34. doi: 10.1097/AOG.0000000000002674.
- Individual participant dataSharing planned: No
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.
Kate' Pettit, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salpingectomy and Tubal ligation in people with Method of Tubal Ligation at the Time of Cesarean Section, run by University of Virginia 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 3 inclusion and 4 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 10 Apr 2018. 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?
Time of tubal ligation (time frame: at time of procedure). 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 NCT03028623, which also lists 1 linked publication.
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 10 Apr 2018.