Salpingectomy at Cesarean Delivery for Ovarian Cancer Reduction (SCORE)

Ovarian Cancer Clinical Trial

— SCORE  

Official title:

Complete Salpingectomy Versus Standard Postpartum Tubal Ligation at the Time of Cesarean Delivery- a Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02374827
• Other study ID #: F140630003 (ST)
• Status: Completed
• Phase: N/A
• First received: February 23, 2015
• Last updated: October 3, 2017
• Start date: April 2015
• Est. completion date: September 2017

Study information

• Verified date: October 2017
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Procedure:
• Standard postpartum tubal ligation
Patients will undergo a standard postpartum tubal ligation by accepted documented surgical procedural methods (Modified Pomeroy or Parkland method)
• Complete Salpingectomy
Patients will undergo a complete salpingectomy by a documented surgical protocol established by accepted surgical procedural methods.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to complete sterilization procedure	The primary outcome will involve measuring the amount of surgical time required to complete the assigned sterilization procedure	At time of procedure
Primary	Completion rate of sterilization procedure	The primary outcome will involve assessing the completion rate of assigned sterilization procedure	At time of procedure
Secondary	Total operative time	Includes cesarean delivery and sterilization procedure time	At time of procedure
Secondary	Mean post-operative pain score		Postpartum admission (3-4 days)
Secondary	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	From time of procedure to 6 weeks postpartum