Salpingectomy at Cesarean Delivery for Ovarian Cancer Reduction (SCORE)

The University of Alabama at Birmingham

Status: Completed

Conditions: Ovarian Cancer

Treatments: Procedure: Standard postpartum tubal ligation; Procedure: Complete Salpingectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02374827

F140630003 (ST)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 25+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Standard postpartum tubal ligation

Active Comparator group

Description:

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.

Treatment:

Procedure: Standard postpartum tubal ligation

Complete Salpingectomy

Experimental group

Description:

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

Treatment:

Procedure: Complete Salpingectomy