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Salpingectomy at Cesarean Delivery for Ovarian Cancer Reduction (SCORE)

NCT ID: NCT02374827

Last Updated: 2017-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-09-30

Brief Summary

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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

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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

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Ovarian Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Standard postpartum tubal ligation

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.

Group Type ACTIVE_COMPARATOR

Standard postpartum tubal ligation

Intervention Type PROCEDURE

Patients will undergo a standard postpartum tubal ligation by accepted documented surgical procedural methods (Modified Pomeroy or Parkland method)

Complete Salpingectomy

In this arm, patients will receive a complete salpingectomy by documented accepted methods.

Group Type EXPERIMENTAL

Complete Salpingectomy

Intervention Type PROCEDURE

Patients will undergo a complete salpingectomy by a documented surgical protocol established by accepted surgical procedural methods.

Interventions

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Standard postpartum tubal ligation

Patients will undergo a standard postpartum tubal ligation by accepted documented surgical procedural methods (Modified Pomeroy or Parkland method)

Intervention Type PROCEDURE

Complete Salpingectomy

Patients will undergo a complete salpingectomy by a documented surgical protocol established by accepted surgical procedural methods.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* Patients no followed in our regional health system
* Known BRCA mutation carrier status
* Age \< 25 years
Minimum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Akila Subramaniam, MD

Maternal-Fetal Medicine Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Akila Subramaniam, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Britt K Erickson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35728603 (View on PubMed)

Subramaniam 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.

Reference Type DERIVED
PMID: 30477808 (View on PubMed)

Subramaniam 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.

Reference Type DERIVED
PMID: 29889762 (View on PubMed)

Other Identifiers

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F140630003 (ST)

Identifier Type: -

Identifier Source: org_study_id