Opportunistic Salpingectomy for Permanent Sterilization at the Time of Cesarean Delivery

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT03135431
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.4
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the safety of performing a bilateral tubal ligation vs. bilateral salpingectomy, two procedures performed for permanent sterilization, at the time of cesarean delivery. The investigators want to determine if performing bilateral salpingectomy at the time of cesarean delivery poses any greater risk for blood loss, as compared to a bilateral tubal ligation.

Condition or Disease	Intervention/Treatment	Phase
Contraception	Procedure: Bilateral Salpingectomy; Procedure: Bilateral Tubal Ligation	N/A

Detailed Description

A non-inferiority, two-arm randomized controlled trial to evaluate the safety and feasibility of prophylactic salpingectomy at the time of a cesarean delivery will be conducted as an initiative to avoid a missed opportunity in the primary prevention of ovarian cancer. Once enrolled and consented, women will be randomized using a stratified block randomization algorithm according to number of prior cesarean deliveries and BMI to either salpingectomy or bilateral tubal ligation. The data collection will include preoperative CBC, time of procedure, postoperative CBC at 24 hours, standard patient demographics, procedural complications, estimated blood loss, return to the OR, length of stay, pain scores, and postoperative complications, including readmission within 6 weeks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Two-arm randomized controlled trialTwo-arm randomized controlled trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Opportunistic Salpingectomy at the Time of Cesarean Delivery: A Randomized Controlled Trial of the Safety of Salpingectomy vs Tubal Ligation
• Actual Study Start Date: May 17, 2017
• Actual Primary Completion Date: May 19, 2018
• Actual Study Completion Date: Jul 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Salpingectomy Bilateral salpingectomy following cesarean delivery	Procedure: Bilateral Salpingectomy; Surgical removal of entire fallopian tubes
Active Comparator: Tubal Ligation Bilateral tubal ligation following cesarean delivery via Parkland or modified Pomeroy methods.	Procedure: Bilateral Tubal Ligation; Surgical tying, cutting, or removal of a portion of the fallopian tubes

Outcome Measures

Primary Outcome Measures

1. Mean Difference Between Pre and Postoperative Hemoglobin (g/dl) [At least 24 but not greater than 48 hours after surgery]

   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.

Secondary Outcome Measures

1. Operative Time [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.

2. Estimated Blood Loss [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Pregnant women

• 21 years of age or older

• Desire permanent sterilization

• Scheduled for a Cesarean delivery

Exclusion Criteria:

• Body Mass Index > 50

• Emergent, 'alpha' Cesarean delivery

• Single ovary/fallopian tube complex

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Vanessa E Torbenson, M.D., Mayo Clinic

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Mar 9, 2018

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Vanessa Torbenson, Consultant Obstetrics and Gynecology, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT03135431
• Other Study ID Numbers: 17-000898
• First Posted: May 1, 2017
• Last Update Posted: Jul 10, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Arm/Group Title	Salpingectomy	Tubal Ligation
Arm/Group Description	Bilateral salpingectomy following cesarean delivery Bilateral Salpingectomy: Surgical removal of entire fallopian tubes	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
Period Title: Overall Study
STARTED	20	20
COMPLETED	18	20
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	Salpingectomy	Tubal Ligation	Total
Arm/Group Description	Bilateral salpingectomy following cesarean delivery Bilateral Salpingectomy: Surgical removal of entire fallopian tubes	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 of all reporting groups
Overall Participants	18	20	38
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.7 (4.8)	34.4 (4.1)	33.6 (4.4)
Sex: Female, Male (Count of Participants)
Female	18 100%	20 100%	38 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
Hispanic and/or Latino	1 5.6%	0 0%	1 2.6%
White	17 94.4%	20 100%	37 97.4%
Region of Enrollment (participants) [Number]
United States	18 100%	20 100%	38 100%
Smoking Status (Count of Participants)
Current	5 27.8%	3 15%	8 21.1%
Former	1 5.6%	7 35%	8 21.1%
Never	12 66.7%	10 50%	22 57.9%
Repeat Cesarean (Count of Participants)
Repeat Cesarean	16 88.9%	17 85%	33 86.8%
First Cesarean	2 11.1%	3 15%	5 13.2%
Gestational Age (weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [weeks]	38.0 (2.4)	37.6 (2.6)	37.8 (2.5)
Gravity (Pregnancies) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Pregnancies]	3	4	4
Parity (viable pregnancies) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [viable pregnancies]	1.5	2	2
Education (Count of Participants)
High school or some High School	2 11.1%	2 10%	4 10.5%
Some College	11 61.1%	5 25%	16 42.1%
4 year or professional degree	5 27.8%	12 60%	17 44.7%
Missing	0 0%	1 5%	1 2.6%

Outcome Measures

1. Primary Outcome

Title	Mean Difference Between Pre and Postoperative Hemoglobin (g/dl)
Description	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.
Time Frame	At least 24 but not greater than 48 hours after surgery

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Salpingectomy	Tubal Ligation
Arm/Group Description	Bilateral salpingectomy following cesarean delivery Bilateral Salpingectomy: Surgical removal of entire fallopian tubes	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
Measure Participants	17	20
Mean (Standard Deviation) [g/dL]	1.4 (0.7)	1.8 (1.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Salpingectomy, Tubal Ligation
	Comments	Assuming that a difference of 0.5 g/dl in the drop in hemoglobin between study arms would be considered as equivalent, and assuming a common standard deviation of 1.1 based on previous studies of cesarean deliveries deliveries , the study would have 80% power to test for non-inferiority with 60 participants in each arm (120 total).
	Type of Statistical Test	Non-Inferiority
	Comments	<=.5g/dl difference in the decrease in hemoglobin was considered equivalent as 1 unit of blood typically raises the hemoglobin by 1g/dl and would be a clinical significant difference.
Statistical Test of Hypothesis	p-Value	0.08
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-.04121
	Confidence Interval	(1-Sided) 95%; to .0712
	Parameter Dispersion	Type: Value:
	Estimation Comments
Other Statistical Analysis		Based on new data from a retrospective study preformed at Mayo Clinic sites an additional power calculation was preformed. Based on the new information, our study was well powered (84%) to assess our primary aim with 38 participants (18 salpingectomy, 20 BTL); therefore, we discontinued recruitment and completed the study with the accrued subjects.

2. Secondary Outcome

Title	Operative Time
Description	Compare mean difference in length of operative time (in minutes) to perform bilateral salpingectomy as compared to standard bilateral tubal ligation, following cesarean delivery.
Time Frame	Day of surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Salpingectomy	Tubal Ligation
Arm/Group Description	Bilateral salpingectomy following cesarean delivery Bilateral Salpingectomy: Surgical removal of entire fallopian tubes	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
Measure Participants	18	20
Mean (Standard Deviation) [mins]	16.3 (5.6)	5.1 (1.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Salpingectomy, Tubal Ligation
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-11.21
	Confidence Interval	(2-Sided) 95%; -14.1 to -8.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	Evidence to suggest salpingecotomy procedure had a longer operation time than a tubal ligation.

3. Secondary Outcome

Title	Estimated Blood Loss
Description	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.
Time Frame	Day of surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Salpingectomy	Tubal Ligation
Arm/Group Description	Bilateral salpingectomy following cesarean delivery Bilateral Salpingectomy: Surgical removal of entire fallopian tubes	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
Measure Participants	18	20
Mean (Standard Deviation) [mL]	842 (84.5)	833 (105.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Salpingectomy, Tubal Ligation
	Comments	Analysis preformed as categorical and categorical variable. Both analyzes had the same conclusion.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.77
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-9.17
	Confidence Interval	(2-Sided) 95%; -72.5 to 54.17
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Adverse event data was collected on participants six weeks from the date of cesarean delivery.
Adverse Event Reporting Description	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."
Arm/Group Title	Salpingectomy		Tubal Ligation
Arm/Group Description	Bilateral salpingectomy (surgical removal or entire fallopian tubes) following cesarean delivery		Bilateral tubal ligation (surgical tying, cutting, or removal of a portion of the fallopian tubes)following cesarean delivery via Parkland or modified Pomeroy methods.
All Cause Mortality
	Salpingectomy		Tubal Ligation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/20 (0%)
Serious Adverse Events
	Salpingectomy		Tubal Ligation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/18 (16.7%)		0/20 (0%)
Blood and lymphatic system disorders
Anemia	1/18 (5.6%)	1	0/20 (0%)	0
Nervous system disorders
Seizure	1/18 (5.6%)	1	0/20 (0%)	0
Reproductive system and breast disorders
Uterine hemorrhage	2/18 (11.1%)	2	0/20 (0%)	0
Other (Not Including Serious) Adverse Events
	Salpingectomy		Tubal Ligation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/18 (5.6%)		2/20 (10%)
Infections and infestations
Upper respiratory infection	1/18 (5.6%)	1	0/20 (0%)	0
Reproductive system and breast disorders
Breast pain	0/18 (0%)	0	1/20 (5%)	1
Surgical and medical procedures
Other, post-operative pain score above goal	0/18 (0%)	0	1/20 (5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.