Ovarian Cancer
Conditions
Keywords
complete salpingectomy, standard tubal ligation, cesarean delivery, feasibility, safety, partial salpingectomy
Brief 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.
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.
Interventions
PROCEDUREStandard postpartum tubal ligation
Patients will undergo a standard postpartum tubal ligation by accepted documented surgical procedural methods (Modified Pomeroy or Parkland method)
PROCEDUREComplete Salpingectomy
Patients will undergo a complete salpingectomy by a documented surgical protocol established by accepted surgical procedural methods.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to complete sterilization procedure | 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 | At time of procedure | The primary outcome will involve assessing the completion rate of assigned sterilization procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total operative time | At time of procedure | Includes cesarean delivery and sterilization procedure time |
| Mean post-operative pain score | Postpartum admission (3-4 days) | — |
| Perioperative complication rate | 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 |
Countries
United States
Outcome results
None listed