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Expedited Interval Tubal Scheduling (ExITS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02875483
Recruitment Status : Completed
First Posted : August 23, 2016
Last Update Posted : October 19, 2022
Information provided by (Responsible Party):
Thomas Jefferson University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Female Tubal Sterilization Other: Expedited Scheduling Other: Standard Scheduling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Expedited Interval Tubal Scheduling: An Intervention to Increase Rates of Completion of Tubal Sterilization Within 6 Months Post-partum
Actual Study Start Date : September 12, 2016
Actual Primary Completion Date : August 24, 2018
Actual Study Completion Date : August 24, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tubal Ligation

Arm Intervention/treatment
Placebo Comparator: Standard Scheduling
Group allocated to follow standard surgical scheduling practices
Other: Standard Scheduling
Scheduling of tubal surgery occurs after completion of post-partum office visit

Experimental: Expedited Scheduling
Group allocated to expedited scheduling practices
Other: Expedited Scheduling
Patients are scheduled for tubal ligation surgery prior to discharge from the post-partum hospital service, with target date 4-8 weeks post-partum.

Primary Outcome Measures :
  1. Completion of Tubal Sterilization [ Time Frame: 6 months ]
    Proportion of participants who complete requested tubal ligation surgery within 6 months of their delivery.

Secondary Outcome Measures :
  1. Participant Satisfaction [ Time Frame: 6 months ]
    Participant satisfaction with process of scheduling and completing surgery

  2. Repeat pregnancy Rates [ Time Frame: 6 months ]
    Proportion of participants with rapid repeat pregnancy within 6 months of delivery

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • >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

Exclusion Criteria:

  • <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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02875483

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United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Thomas Jefferson University Identifier: NCT02875483    
Other Study ID Numbers: 16D.494
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: October 19, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No