Female Tubal SterilizationExITSNCT02875483
Expedited Interval Tubal Scheduling
A study testing Expedited Scheduling and Standard Scheduling in people with Female Tubal Sterilization, run by Thomas Jefferson University at 1 site in United States.
Trial summary
Over 50% of all pregnancies that occur in the US are unintended, and unintended pregnancy is detrimental to maternal and child health. Tubal sterilization may be performed immediately following a delivery, or as an interval procedure remote from pregnancy. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Tubal Sterilization
- What is being tested?
- Expedited Scheduling and Standard Scheduling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2016to 24 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >21 years of age (required for sterilization by Medicaid rules)
- Requested sterilization either during antepartum care or at time of delivery
- Did not have sterilization performed on L\&D for any reason
- Confirmed desire for sterilization during post-partum hospitalization (has not changed mind)
- Has commercial or Medicaid insurance that will allow for outpatient surgery (including pregnancy-related emergency Medicaid)
- Consent to phone follow-up calls regarding study in the 6 months following enrollment
Who cannot join
- <21 years of age
- Unable to provide informed consent
- Not a candidate for a laparoscopic or hysteroscopic procedure for any medical reason
- Uninsured or undocumented status that would prevent scheduling of an outpatient surgery
- Unable to provide reasonably reliable contact information
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Expedited Interval Tubal Scheduling: An Intervention to Increase Rates of Completion of Tubal Sterilization Within 6 Months Post-partum
Over 50% of all pregnancies that occur in the US are unintended, and unintended pregnancy is detrimental to maternal and child health. Tubal sterilization may be performed immediately following a delivery, or as an interval procedure remote from pregnancy. Many women request sterilization to follow delivery, but it is frequently not completed during the peri-partum hospitalization. Women who are denied an immediate post-partum tubal are generally candidates to complete the procedure as an interval surgery within a few months of delivery, but few do so. Women who request tubal sterilization and do not receive it are at highest risk for a rapid repeat pregnancy, with as many as 46% having an unintended pregnancy within 1 year.
The standard care at many institutions for a patient denied tubal sterilization during hospitalization is to offer a short term contraceptive and instruct the patient to follow up for the standard post-partum outpatient visit in 4-6 weeks. If the patient still desires tubal sterilization at that time, the surgical procedure will be scheduled. No-show rates for post-partum care are high at about 50%-60%, and therefore, many patients are never scheduled for their surgery. If the process of scheduling interval tubal sterilization surgery could be expedited, rates of completion could be improved.
Read the detailed description
Identification of potential participants: On admission to the hospital for labor, all women will be asked if they were planning to tie their tubes after their delivery. Women who requested tubal ligation and have not received this on post-partum day one, and who are not anticipated to have it completed on post-partum days 2 or 3, and who did not have a contraceptive device (IUD or Nexplanon) placed that the time of delivery will be identified from hospital service lists.
Enrollment: All patients meeting inclusion criteria will be approached by study personnel and asked about whether sterilization is their preferred contraceptive method. If the potential participant still expresses a desire for permanent sterilization, the potential participant will be offered enrollment in the study. The study will be described, and the expected preferred method of sterilization identified. The participant will sign informed consent.
Allocation Concealment: A randomization sequence will be developed with a computerized number generator, and will generate participant assignments in a 1:1 ration with randomly permuted block sizes of 4, 6, and 8. A person not involved with study enrollment will place cards with participant assignments in a series of sequentially numbered, sealed opaque sealed envelopes. These envelopes will be stored on the post partum floor, and after a patient completes the informed consent, the next sequential envelope will be opened.
Randomization: The potential candidate will be randomized by opening of the next sequentially numbered sealed envelope. The assignment will be noted and disclosed. The assignment will be noted in the study chart, and the card with the assignment will be stored with the chart.
Study protocol following randomization:
If the participant is assigned to the standard care arm, the participant will be instructed to present for her post-partum visit, and that surgical procedure will be scheduled at that time. These participants will be offered appropriate short term contraceptive. This reflects current standard of care regarding post-partum follow up and contraception.
If the participant is assigned to the expedited scheduling arm, the preferred method of sterilization (laparoscopic or hysteroscopic) will be confirmed. The available dates for surgery in the appropriate window (4-8 weeks post-partum) will be offered, and the participant will confirm her preferred dates. The surgery scheduling team will be contacted, and the patient will be placed on the schedule. If a date cannot be definitively confirmed prior to discharge, the participant will be instructed to expect a call from the surgery schedulers to confirm the surgical date within 3 days of hospital discharge. In that phone call, administrators will provide information for pre-admission testing date to complete preoperative laboratory work if needed. The participant will be instructed to schedule a routine post-partum visit as well per usual protocols. All participants will be offered the appropriate short-term contraceptive.
Follow-up after hospital discharge. Patients in the expedited group will receive the standard phone calls from the surgery scheduling team regarding pre-operative appointments and the peri-operative nurses on the day prior to schedule surgery. Participants will not receive any other specialized reminders regarding their surgical date or intentions for follow up. If participants contact the office requesting a change to a surgical date, this will be allowed.
Per usual surgical procedures, if participants do not present for their scheduled surgery, they will be contacted and offered an opportunity to re-schedule. If participants miss more than one scheduled surgery date, they will not be contacted further to re-schedule; however, if the participant calls the office to schedule independently, another surgical date will be offered.
Patients in the standard of care group will receive standard discharge summary and instructions which include instruction to contact the outpatient OB-Gyn office to schedule post-partum follow-up in about 6 weeks. Once scheduled for an appointment, participants will receive the standard automated appointment reminder call or text. Participants will not receive any specialized reminders regarding follow-up for either routine post-partum care or regarding scheduling of sterilization surgery. Participants will not be seen by study personnel at this visit to encourage or facilitate scheduling of tubal, as the goal is for this group to receive current standard care. Data regarding the outcome of this visit will be abstracted from the post-partum chart by study personnel.
Study Completion:
Participants will be considered exited from the study at these endpoints:
- Tubal is completed as scheduled - do satisfaction survey: study complete
- Seen for follow up, and state definitively that they have changed mind about tubal and no longer desire it - do satisfaction survey: study complete (Survey B for survey specific to those who have changed their mind regarding tubal)
- Are seen for follow up within 6 month, state intention to complete tubal. It is done within 6 months. Do survey at time of tubal: study complete.
- Are seen for follow up within 6 months, state intention to complete tubal, but it has not been completed at 6 month mark - will be contacted by phone, queried about barriers and why not done, and complete satisfaction survey: study complete (Survey C for survey specific to non-completion of follow up)
- Are not seen for follow up at all within 6 months - will be contacted by phone at 6-month point to determine if tubal done elsewhere, method of contraception, interval pregnancy, complete satisfaction survey (Survey C): study complete
- Conditions
- Female Tubal Sterilization
- Being tested
- Expedited Scheduling, Standard Scheduling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expedited SchedulingOther
Patients are scheduled for tubal ligation surgery prior to discharge from the post-partum hospital service, with target date 4-8 weeks post-partum.
Standard SchedulingOther
Scheduling of tubal surgery occurs after completion of post-partum office visit
| Study group | Role | What they receive |
|---|---|---|
| Standard Scheduling | Placebo comparator | Group allocated to follow standard surgical scheduling practices Receives: Other: Standard Scheduling |
| Expedited Scheduling | Experimental | Group allocated to expedited scheduling practices Receives: Other: Expedited Scheduling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of Tubal Sterilization
Proportion of participants who complete requested tubal ligation surgery within 6 months of their delivery.
Measured: 6 months
Secondary outcomes (2)
Participant Satisfaction
Participant satisfaction with process of scheduling and completing surgery
Measured: 6 months
Repeat pregnancy Rates
Proportion of participants with rapid repeat pregnancy within 6 months of delivery
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study start12 Sep 2016
- Primary completion24 Aug 2018
- Study completion24 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Female Tubal SterilizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875483
- Sponsor's protocol ID
- 16D.494
- Acronym
- ExITS
- Status last verified
- Oct 2022
- First submitted
- 18 Aug 2016
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Mercier RJ, Perriera L, Godcharles C, Shaber A. Expedited Scheduling of Interval Tubal Ligation: A Randomized Controlled Trial. Obstet Gynecol. 2019 Dec;134(6):1178-1185. doi: 10.1097/AOG.0000000000003550.
PubMed 31764727
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expedited Interval Tubal Scheduling: An Intervention to Increase Rates of Completion of Tubal Sterilization Within 6 Months Post-partum
- ClinicalTrials.gov ID
- NCT02875483
- Acronym / sponsor ID
- ExITS / 16D.494
- Conditions
- Female Tubal Sterilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 12 Sep 2016 (actual)
- Primary completion
- 24 Aug 2018 (actual)
- Study completion
- 24 Aug 2018 (actual)
- First posted
- 23 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Over 50% of all pregnancies that occur in the US are unintended, and unintended pregnancy is detrimental to maternal and child health. Tubal sterilization may be performed immediately following a delivery, or as an interval procedure remote from pregnancy. Many women request sterilization to follow delivery, but it is frequently not completed during the peri-partum hospitalization. Women who are denied an immediate post-partum tubal are generally candidates to complete the procedure as an interval surgery within a few months of delivery, but few do so. Women who request tubal sterilization and do not receive it are at highest risk for a rapid repeat pregnancy, with as many as 46% having an unintended pregnancy within 1 year.
The standard care at many institutions for a patient denied tubal sterilization during hospitalization is to offer a short term contraceptive and instruct the patient to follow up for the standard post-partum outpatient visit in 4-6 weeks. If the patient still desires tubal sterilization at that time, the surgical procedure will be scheduled. No-show rates for post-partum care are high at about 50%-60%, and therefore, many patients are never scheduled for their surgery. If the process of scheduling interval tubal sterilization surgery could be expedited, rates of completion could be improved.
Detailed description
Identification of potential participants: On admission to the hospital for labor, all women will be asked if they were planning to tie their tubes after their delivery. Women who requested tubal ligation and have not received this on post-partum day one, and who are not anticipated to have it completed on post-partum days 2 or 3, and who did not have a contraceptive device (IUD or Nexplanon) placed that the time of delivery will be identified from hospital service lists.
Enrollment: All patients meeting inclusion criteria will be approached by study personnel and asked about whether sterilization is their preferred contraceptive method. If the potential participant still expresses a desire for permanent sterilization, the potential participant will be offered enrollment in the study. The study will be described, and the expected preferred method of sterilization identified. The participant will sign informed consent.
Allocation Concealment: A randomization sequence will be developed with a computerized number generator, and will generate participant assignments in a 1:1 ration with randomly permuted block sizes of 4, 6, and 8. A person not involved with study enrollment will place cards with participant assignments in a series of sequentially numbered, sealed opaque sealed envelopes. These envelopes will be stored on the post partum floor, and after a patient completes the informed consent, the next sequential envelope will be opened.
Randomization: The potential candidate will be randomized by opening of the next sequentially numbered sealed envelope. The assignment will be noted and disclosed. The assignment will be noted in the study chart, and the card with the assignment will be stored with the chart.
Study protocol following randomization:
If the participant is assigned to the standard care arm, the participant will be instructed to present for her post-partum visit, and that surgical procedure will be scheduled at that time. These participants will be offered appropriate short term contraceptive. This reflects current standard of care regarding post-partum follow up and contraception.
If the participant is assigned to the expedited scheduling arm, the preferred method of sterilization (laparoscopic or hysteroscopic) will be confirmed. The available dates for surgery in the appropriate window (4-8 weeks post-partum) will be offered, and the participant will confirm her preferred dates. The surgery scheduling team will be contacted, and the patient will be placed on the schedule. If a date cannot be definitively confirmed prior to discharge, the participant will be instructed to expect a call from the surgery schedulers to confirm the surgical date within 3 days of hospital discharge. In that phone call, administrators will provide information for pre-admission testing date to complete preoperative laboratory work if needed. The participant will be instructed to schedule a routine post-partum visit as well per usual protocols. All participants will be offered the appropriate short-term contraceptive.
Follow-up after hospital discharge. Patients in the expedited group will receive the standard phone calls from the surgery scheduling team regarding pre-operative appointments and the peri-operative nurses on the day prior to schedule surgery. Participants will not receive any other specialized reminders regarding their surgical date or intentions for follow up. If participants contact the office requesting a change to a surgical date, this will be allowed.
Per usual surgical procedures, if participants do not present for their scheduled surgery, they will be contacted and offered an opportunity to re-schedule. If participants miss more than one scheduled surgery date, they will not be contacted further to re-schedule; however, if the participant calls the office to schedule independently, another surgical date will be offered.
Patients in the standard of care group will receive standard discharge summary and instructions which include instruction to contact the outpatient OB-Gyn office to schedule post-partum follow-up in about 6 weeks. Once scheduled for an appointment, participants will receive the standard automated appointment reminder call or text. Participants will not receive any specialized reminders regarding follow-up for either routine post-partum care or regarding scheduling of sterilization surgery. Participants will not be seen by study personnel at this visit to encourage or facilitate scheduling of tubal, as the goal is for this group to receive current standard care. Data regarding the outcome of this visit will be abstracted from the post-partum chart by study personnel.
Study Completion:
Participants will be considered exited from the study at these endpoints:
- Tubal is completed as scheduled - do satisfaction survey: study complete
- Seen for follow up, and state definitively that they have changed mind about tubal and no longer desire it - do satisfaction survey: study complete (Survey B for survey specific to those who have changed their mind regarding tubal)
- Are seen for follow up within 6 month, state intention to complete tubal. It is done within 6 months. Do survey at time of tubal: study complete.
- Are seen for follow up within 6 months, state intention to complete tubal, but it has not been completed at 6 month mark - will be contacted by phone, queried about barriers and why not done, and complete satisfaction survey: study complete (Survey C for survey specific to non-completion of follow up)
- Are not seen for follow up at all within 6 months - will be contacted by phone at 6-month point to determine if tubal done elsewhere, method of contraception, interval pregnancy, complete satisfaction survey (Survey C): study complete
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Scheduling | Placebo comparator | Other: Standard SchedulingGroup allocated to follow standard surgical scheduling practices |
| Expedited Scheduling | Experimental | Other: Expedited SchedulingGroup allocated to expedited scheduling practices |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- >21 years of age (required for sterilization by Medicaid rules)
- Requested sterilization either during antepartum care or at time of delivery
- Did not have sterilization performed on L\&D for any reason
- Confirmed desire for sterilization during post-partum hospitalization (has not changed mind)
- Has commercial or Medicaid insurance that will allow for outpatient surgery (including pregnancy-related emergency Medicaid)
Key exclusion criteria (5 listed)
- <21 years of age
- Unable to provide informed consent
- Not a candidate for a laparoscopic or hysteroscopic procedure for any medical reason
- Uninsured or undocumented status that would prevent scheduling of an outpatient surgery
- Unable to provide reasonably reliable contact information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expedited SchedulingPatients are scheduled for tubal ligation surgery prior to discharge from the post-partum hospital service, with target date 4-8 weeks post-partum. | Other | Expedited Scheduling |
| Standard SchedulingScheduling of tubal surgery occurs after completion of post-partum office visit | Other | Standard Scheduling |
Primary outcome
Completion of Tubal Sterilization
Time frame: 6 months
Proportion of participants who complete requested tubal ligation surgery within 6 months of their delivery.
2 secondary outcomes
Participant Satisfaction
Time frame: 6 months
Repeat pregnancy Rates
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Derived from this study: PubMed 31764727Mercier RJ, Perriera L, Godcharles C, Shaber A. Expedited Scheduling of Interval Tubal Ligation: A Randomized Controlled Trial. Obstet Gynecol. 2019 Dec;134(6):1178-1185. doi: 10.1097/AOG.0000000000003550.
- Individual participant dataSharing planned: No
Related trials for Female Tubal Sterilization
Recruiting
Assessment of Tubal Occlusion During Minimally Invasive Myomectomy
Fallopian Tube Patency Tests, Fibroid/Myoma (Uterus/Cervix)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expedited Scheduling and Standard Scheduling in people with Female Tubal Sterilization, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of Tubal Sterilization (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02875483, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.