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Completed

NCT Number: NCT02374827

Salpingectomy at Cesarean Delivery for Ovarian Cancer Reduction (SCORE)

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

25 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard postpartum tubal ligation

Procedure

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

Complete Salpingectomy

Procedure

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

Primary outcomes

  1. 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

  2. Completion rate of sterilization procedure

    Time frame: At time of procedure

    The primary outcome will involve assessing the completion rate of assigned sterilization procedure

Secondary outcomes

  1. Total operative time

    Time frame: At time of procedure

    Includes cesarean delivery and sterilization procedure time

  2. Mean post-operative pain score

    Time frame: Postpartum admission (3-4 days)

  3. Perioperative complication rate

    Time frame: From time of procedure to 6 weeks postpartum

    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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Acronym: SCORE

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 2, 2015
Registry last updated
Oct 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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