Trial Outcomes & Findings for Opportunistic Salpingectomy for Permanent Sterilization at the Time of Cesarean Delivery (NCT NCT03135431)

Last Updated: 2019-07-10

Results Overview

Identify the mean difference in pre and postoperative hemoglobin for patients undergoing salpingectomy for sterilization vs. patients undergoing standard bilateral tubal ligation via mid-segment resection of the fallopian tube at the time of cesarean delivery.

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

At least 24 but not greater than 48 hours after surgery

Results posted on

2019-07-10

Participant Flow

Participant milestones

Participant milestones
Measure	Salpingectomy Bilateral salpingectomy following cesarean delivery Bilateral Salpingectomy: Surgical removal of entire fallopian tubes	Tubal Ligation Bilateral tubal ligation following cesarean delivery via Parkland or modified Pomeroy methods. Bilateral Tubal Ligation: Surgical tying, cutting, or removal of a portion of the fallopian tubes
Overall Study STARTED	20	20
Overall Study COMPLETED	18	20
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Salpingectomy Bilateral salpingectomy following cesarean delivery Bilateral Salpingectomy: Surgical removal of entire fallopian tubes	Tubal Ligation Bilateral tubal ligation following cesarean delivery via Parkland or modified Pomeroy methods. Bilateral Tubal Ligation: Surgical tying, cutting, or removal of a portion of the fallopian tubes
Overall Study Study Surgeon not available	2	0

Baseline Characteristics

Opportunistic Salpingectomy for Permanent Sterilization at the Time of Cesarean Delivery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Salpingectomy n=18 Participants Bilateral salpingectomy following cesarean delivery Bilateral Salpingectomy: Surgical removal of entire fallopian tubes	Tubal Ligation n=20 Participants Bilateral tubal ligation following cesarean delivery via Parkland or modified Pomeroy methods. Bilateral Tubal Ligation: Surgical tying, cutting, or removal of a portion of the fallopian tubes	Total n=38 Participants Total of all reporting groups
Age, Continuous	32.7 years STANDARD_DEVIATION 4.8 • n=5 Participants	34.4 years STANDARD_DEVIATION 4.1 • n=7 Participants	33.6 years STANDARD_DEVIATION 4.4 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	20 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · Hispanic and/or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	17 Participants n=5 Participants	20 Participants n=7 Participants	37 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	20 participants n=7 Participants	38 participants n=5 Participants
Smoking Status Current	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Smoking Status Former	1 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants
Smoking Status Never	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Repeat Cesarean Repeat Cesarean	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Repeat Cesarean First Cesarean	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Gestational Age	38.0 weeks STANDARD_DEVIATION 2.4 • n=5 Participants	37.6 weeks STANDARD_DEVIATION 2.6 • n=7 Participants	37.8 weeks STANDARD_DEVIATION 2.5 • n=5 Participants
Gravity	3 Pregnancies n=5 Participants	4 Pregnancies n=7 Participants	4 Pregnancies n=5 Participants
Parity	1.5 viable pregnancies n=5 Participants	2 viable pregnancies n=7 Participants	2 viable pregnancies n=5 Participants
Education High school or some High School	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Education Some College	11 Participants n=5 Participants	5 Participants n=7 Participants	16 Participants n=5 Participants
Education 4 year or professional degree	5 Participants n=5 Participants	12 Participants n=7 Participants	17 Participants n=5 Participants
Education Missing	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: At least 24 but not greater than 48 hours after surgery

Population: One patient in the Salpingectomy group is was missing post operation hemoglobin

Outcome measures

Outcome measures
Measure	Salpingectomy n=17 Participants Bilateral salpingectomy following cesarean delivery Bilateral Salpingectomy: Surgical removal of entire fallopian tubes	Tubal Ligation n=20 Participants Bilateral tubal ligation following cesarean delivery via Parkland or modified Pomeroy methods. Bilateral Tubal Ligation: Surgical tying, cutting, or removal of a portion of the fallopian tubes
Mean Difference Between Pre and Postoperative Hemoglobin (g/dl)	1.4 g/dL Standard Deviation 0.7	1.8 g/dL Standard Deviation 1.0

SECONDARY outcome

Timeframe: Day of surgery

Compare mean difference in length of operative time (in minutes) to perform bilateral salpingectomy as compared to standard bilateral tubal ligation, following cesarean delivery.

Outcome measures

Outcome measures
Measure	Salpingectomy n=18 Participants Bilateral salpingectomy following cesarean delivery Bilateral Salpingectomy: Surgical removal of entire fallopian tubes	Tubal Ligation n=20 Participants Bilateral tubal ligation following cesarean delivery via Parkland or modified Pomeroy methods. Bilateral Tubal Ligation: Surgical tying, cutting, or removal of a portion of the fallopian tubes
Operative Time	16.3 mins Standard Deviation 5.6	5.1 mins Standard Deviation 1.6

SECONDARY outcome

Timeframe: Day of surgery

Identify mean difference in estimated total blood loss as a result of standard bilateral tubal ligation surgical procedure and bilateral salpingectomy procedure, following cesarean delivery.

Outcome measures

Outcome measures
Measure	Salpingectomy n=18 Participants Bilateral salpingectomy following cesarean delivery Bilateral Salpingectomy: Surgical removal of entire fallopian tubes	Tubal Ligation n=20 Participants Bilateral tubal ligation following cesarean delivery via Parkland or modified Pomeroy methods. Bilateral Tubal Ligation: Surgical tying, cutting, or removal of a portion of the fallopian tubes
Estimated Blood Loss	842 mL Standard Deviation 84.5	833 mL Standard Deviation 105.5

Adverse Events

Salpingectomy

Serious events: 3 serious events

Other events: 1 other events

Deaths: 0 deaths

Tubal Ligation

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Salpingectomy n=18 participants at risk Bilateral salpingectomy (surgical removal or entire fallopian tubes) following cesarean delivery	Tubal Ligation n=20 participants at risk Bilateral tubal ligation (surgical tying, cutting, or removal of a portion of the fallopian tubes)following cesarean delivery via Parkland or modified Pomeroy methods.
Nervous system disorders Seizure	5.6% 1/18 • Number of events 1 • Adverse event data was collected on participants six weeks from the date of cesarean delivery. Definition also included the following statement: "problems/events that in the opinion of the PI may have adversely affected the rights, safety, or welfare of the subjects or others, or substantially compromised the research data."	0.00% 0/20 • Adverse event data was collected on participants six weeks from the date of cesarean delivery. Definition also included the following statement: "problems/events that in the opinion of the PI may have adversely affected the rights, safety, or welfare of the subjects or others, or substantially compromised the research data."
Blood and lymphatic system disorders Anemia	5.6% 1/18 • Number of events 1 • Adverse event data was collected on participants six weeks from the date of cesarean delivery. Definition also included the following statement: "problems/events that in the opinion of the PI may have adversely affected the rights, safety, or welfare of the subjects or others, or substantially compromised the research data."	0.00% 0/20 • Adverse event data was collected on participants six weeks from the date of cesarean delivery. Definition also included the following statement: "problems/events that in the opinion of the PI may have adversely affected the rights, safety, or welfare of the subjects or others, or substantially compromised the research data."
Reproductive system and breast disorders Uterine hemorrhage	11.1% 2/18 • Number of events 2 • Adverse event data was collected on participants six weeks from the date of cesarean delivery. Definition also included the following statement: "problems/events that in the opinion of the PI may have adversely affected the rights, safety, or welfare of the subjects or others, or substantially compromised the research data."	0.00% 0/20 • Adverse event data was collected on participants six weeks from the date of cesarean delivery. Definition also included the following statement: "problems/events that in the opinion of the PI may have adversely affected the rights, safety, or welfare of the subjects or others, or substantially compromised the research data."

Other adverse events

Other adverse events
Measure	Salpingectomy n=18 participants at risk Bilateral salpingectomy (surgical removal or entire fallopian tubes) following cesarean delivery	Tubal Ligation n=20 participants at risk Bilateral tubal ligation (surgical tying, cutting, or removal of a portion of the fallopian tubes)following cesarean delivery via Parkland or modified Pomeroy methods.
Surgical and medical procedures Other, post-operative pain score above goal	0.00% 0/18 • Adverse event data was collected on participants six weeks from the date of cesarean delivery. Definition also included the following statement: "problems/events that in the opinion of the PI may have adversely affected the rights, safety, or welfare of the subjects or others, or substantially compromised the research data."	5.0% 1/20 • Number of events 1 • Adverse event data was collected on participants six weeks from the date of cesarean delivery. Definition also included the following statement: "problems/events that in the opinion of the PI may have adversely affected the rights, safety, or welfare of the subjects or others, or substantially compromised the research data."
Reproductive system and breast disorders Breast pain	0.00% 0/18 • Adverse event data was collected on participants six weeks from the date of cesarean delivery. Definition also included the following statement: "problems/events that in the opinion of the PI may have adversely affected the rights, safety, or welfare of the subjects or others, or substantially compromised the research data."	5.0% 1/20 • Number of events 1 • Adverse event data was collected on participants six weeks from the date of cesarean delivery. Definition also included the following statement: "problems/events that in the opinion of the PI may have adversely affected the rights, safety, or welfare of the subjects or others, or substantially compromised the research data."
Infections and infestations Upper respiratory infection	5.6% 1/18 • Number of events 1 • Adverse event data was collected on participants six weeks from the date of cesarean delivery. Definition also included the following statement: "problems/events that in the opinion of the PI may have adversely affected the rights, safety, or welfare of the subjects or others, or substantially compromised the research data."	0.00% 0/20 • Adverse event data was collected on participants six weeks from the date of cesarean delivery. Definition also included the following statement: "problems/events that in the opinion of the PI may have adversely affected the rights, safety, or welfare of the subjects or others, or substantially compromised the research data."

Additional Information

Vanessa Torbenson, M.D.

Mayo Clinic

Phone: 507-266-9873

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place