Ovarian CancerSCORENCT02374827
Salpingectomy at Cesarean Delivery for Ovarian Cancer Reduction (SCORE)
A study testing Standard postpartum tubal ligation and Complete Salpingectomy in people with Ovarian Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
To compare the feasibility and surgical outcomes between complete salpingectomy and standard postpartum tubal ligation (partial salpingectomy) at the time of cesarean delivery in women with undesired future fertility. as a possible ovarian cancer risk-reducing procedure. Read more about this study
- Who is it for?
- Ages 25 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Standard postpartum tubal ligation and Complete Salpingectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Sep 2017
- 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 25 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All pregnant women > 25 years receiving prenatal care within the UAB Health System, and planning to undergo tubal ligation at the time of their scheduled cesarean delivery (primary or repeat)
- Informed consent obtained
Who cannot join
- Inability to obtain informed consent
- Fetal death or anomalies
- Preterm delivery < 36 weeks gestation
- Immune-compromising disease
- Chronic steroid use
- Chronic prophylactic or therapeutic anti-coagulation
Show all 9Show fewer
- Patients no followed in our regional health system
- Known BRCA mutation carrier status
- Age < 25 years
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35249
About this study
Official title: Complete Salpingectomy Versus Standard Postpartum Tubal Ligation at the Time of Cesarean Delivery- a Randomized Controlled Study
To compare the feasibility and surgical outcomes between complete salpingectomy and standard postpartum tubal ligation (partial salpingectomy) at the time of cesarean delivery in women with undesired future fertility. as a possible ovarian cancer risk-reducing procedure.
Read the detailed description
All pregnant women receiving prenatal care within the UAB Health System, and planning to undergo tubal ligation at the time of their scheduled cesarean delivery (primary or repeat) will be approached about the study. Patients will be randomized to receive either the standard tubal ligation practice at our institution (modified Pomeroy procedure or Parkland) or a complete salpingectomy. The objective of this trial is to evaluate if a complete salpingectomy can be performed safely and comparable to a standard postpartum tubal ligation.
- Conditions
- Ovarian Cancer
- Being tested
- Standard postpartum tubal ligation, Complete Salpingectomy
- Keywords
- complete salpingectomy, standard tubal ligation, cesarean delivery, feasibility, safety, partial salpingectomy
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard postpartum tubal ligationProcedure or surgery
Patients will undergo a standard postpartum tubal ligation by accepted documented surgical procedural methods (Modified Pomeroy or Parkland method)
Complete SalpingectomyProcedure or surgery
Patients will undergo a complete salpingectomy by a documented surgical protocol established by accepted surgical procedural methods.
| Study group | Role | What they receive |
|---|---|---|
| Standard postpartum tubal ligation | Active comparator | In this arm, patients will receive the standard postpartum tubal ligation by accepted methods (procedure names are the following: Modified pomeroy technique or Parkland method). These methods are procedures for completing a partial salpingectomy. Receives: Procedure: Standard postpartum tubal ligation |
| Complete Salpingectomy | Experimental | In this arm, patients will receive a complete salpingectomy by documented accepted methods. Receives: Procedure: Complete Salpingectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete sterilization procedure
The primary outcome will involve measuring the amount of surgical time required to complete the assigned sterilization procedure
Measured: At time of procedure
Completion rate of sterilization procedure
The primary outcome will involve assessing the completion rate of assigned sterilization procedure
Measured: At time of procedure
Secondary outcomes (3)
Total operative time
Includes cesarean delivery and sterilization procedure time
Measured: At time of procedure
Mean post-operative pain score
Measured: Postpartum admission (3-4 days)
Perioperative complication rate
Composite assessment of the following: estimated blood loss, need for blood transfusion, intra-abdominal hemorrhage/hematoma, need for readmission, need for reoperation, need for additional surgical procedure, major post-operative complication
Measured: From time of procedure to 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akila Subramaniam, MD, University of Alabama at Birmingham
- Investigators
- Akila Subramaniam, MD, MPH, Principal investigator, University of Alabama at BirminghamBritt K Erickson, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374827
- Sponsor's protocol ID
- F140630003 (ST)
- Acronym
- SCORE
- Status last verified
- Oct 2017
- First submitted
- 23 Feb 2015
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ostby SA, Blanchard CT, Sanjanwala AR, Szychowski JM, Leath CA 3rd, Huh WK, Subramaniam A. Feasibility, Safety, and Provider Perspectives of Bipolar Electrosurgical Cautery Device for (Opportunistic or Complete) Salpingectomy at the Time of Cesarean Delivery. Am J Perinatol. 2024 Apr;41(6):804-813. doi: 10.1055/s-0042-1748525. Epub 2022 Jun 21.
PubMed 35728603Subramaniam A, Einerson BD, Blanchard CT, Erickson BK, Szychowski J, Leath CA 3rd, Biggio JR, Huh WK. The cost-effectiveness of opportunistic salpingectomy versus standard tubal ligation at the time of cesarean delivery for ovarian cancer risk reduction. Gynecol Oncol. 2019 Jan;152(1):127-132. doi: 10.1016/j.ygyno.2018.11.009. Epub 2018 Nov 23.
PubMed 30477808Subramaniam A, Blanchard CT, Erickson BK, Szychowski J, Leath CA, Biggio JR, Huh WK. Feasibility of Complete Salpingectomy Compared With Standard Postpartum Tubal Ligation at Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jul;132(1):20-27. doi: 10.1097/AOG.0000000000002646.
PubMed 29889762
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complete Salpingectomy Versus Standard Postpartum Tubal Ligation at the Time of Cesarean Delivery- a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02374827
- Acronym / sponsor ID
- SCORE / F140630003 (ST)
- Conditions
- Ovarian Cancer
- Keywords
- complete salpingectomy, standard tubal ligation, cesarean delivery, feasibility, safety, partial salpingectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 2 Mar 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.
To compare the feasibility and surgical outcomes between complete salpingectomy and standard postpartum tubal ligation (partial salpingectomy) at the time of cesarean delivery in women with undesired future fertility. as a possible ovarian cancer risk-reducing procedure.
Detailed description
All pregnant women receiving prenatal care within the UAB Health System, and planning to undergo tubal ligation at the time of their scheduled cesarean delivery (primary or repeat) will be approached about the study. Patients will be randomized to receive either the standard tubal ligation practice at our institution (modified Pomeroy procedure or Parkland) or a complete salpingectomy. The objective of this trial is to evaluate if a complete salpingectomy can be performed safely and comparable to a standard postpartum tubal ligation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard postpartum tubal ligation | Active comparator | Procedure: Standard postpartum tubal ligationIn this arm, patients will receive the standard postpartum tubal ligation by accepted methods (procedure names are the following: Modified pomeroy technique or Parkland method). These methods are procedures for completing a partial salpingectomy. |
| Complete Salpingectomy | Experimental | Procedure: Complete SalpingectomyIn this arm, patients will receive a complete salpingectomy by documented accepted methods. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All pregnant women > 25 years receiving prenatal care within the UAB Health System, and planning to undergo tubal ligation at the time of their scheduled cesarean delivery (primary or repeat)
- Informed consent obtained
Key exclusion criteria (9 listed)
- Inability to obtain informed consent
- Fetal death or anomalies
- Preterm delivery < 36 weeks gestation
- Immune-compromising disease
- Chronic steroid use
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 |
|---|---|---|
| Standard postpartum tubal ligationPatients will undergo a standard postpartum tubal ligation by accepted documented surgical procedural methods (Modified Pomeroy or Parkland method) | Procedure or surgery | Standard postpartum tubal ligation |
| Complete SalpingectomyPatients will undergo a complete salpingectomy by a documented surgical protocol established by accepted surgical procedural methods. | Procedure or surgery | Complete Salpingectomy |
Primary outcome
Time to complete sterilization procedure
Time frame: At time of procedure
The primary outcome will involve measuring the amount of surgical time required to complete the assigned sterilization procedure
Completion rate of sterilization procedure
Time frame: At time of procedure
The primary outcome will involve assessing the completion rate of assigned sterilization procedure
3 secondary outcomes
Total operative time
Time frame: At time of procedure
Mean post-operative pain score
Time frame: Postpartum admission (3-4 days)
Perioperative complication rate
Time frame: From time of procedure to 6 weeks postpartum
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 5 Oct 2017.
- Derived from this study: PubMed 35728603Ostby SA, Blanchard CT, Sanjanwala AR, Szychowski JM, Leath CA 3rd, Huh WK, Subramaniam A. Feasibility, Safety, and Provider Perspectives of Bipolar Electrosurgical Cautery Device for (Opportunistic or Complete) Salpingectomy at the Time of Cesarean Delivery. Am J Perinatol. 2024 Apr;41(6):804-813. doi: 10.1055/s-0042-1748525. Epub 2022 Jun 21.
- Derived from this study: PubMed 30477808Subramaniam A, Einerson BD, Blanchard CT, Erickson BK, Szychowski J, Leath CA 3rd, Biggio JR, Huh WK. The cost-effectiveness of opportunistic salpingectomy versus standard tubal ligation at the time of cesarean delivery for ovarian cancer risk reduction. Gynecol Oncol. 2019 Jan;152(1):127-132. doi: 10.1016/j.ygyno.2018.11.009. Epub 2018 Nov 23.
- Derived from this study: PubMed 29889762Subramaniam A, Blanchard CT, Erickson BK, Szychowski J, Leath CA, Biggio JR, Huh WK. Feasibility of Complete Salpingectomy Compared With Standard Postpartum Tubal Ligation at Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jul;132(1):20-27. doi: 10.1097/AOG.0000000000002646.
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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.
Akila Subramaniam, MD, MPH principal investigator
University of Alabama at Birmingham
Britt K Erickson, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard postpartum tubal ligation and Complete Salpingectomy in people with Ovarian Cancer, run by University of Alabama at Birmingham 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 2 inclusion and 9 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 5 Oct 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?
Time to complete sterilization procedure (time frame: At time of procedure). 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?
On the ClinicalTrials.gov record for NCT02374827, which also lists 3 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 5 Oct 2017.