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Choice of Modality of Follow up for Medication Abortion

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.
 
ClinicalTrials.gov Identifier: NCT04056637
Recruitment Status : Terminated (COVID-19 Impacted Service Delivery and Research Infrastructure)
First Posted : August 14, 2019
Last Update Posted : May 28, 2020
Sponsor:
Collaborator:
Gynuity Health Projects
Information provided by (Responsible Party):
Stanford University

Brief Summary:

This study will assess the impact of providing medication abortion-seeking clients a choice for follow-up in practice. Clients presenting at or less than 63 days pregnant (based on last menstrual period) at the study site for first trimester medication abortion will be invited to participate. We hypothesize that providing clients with flexible follow-up options will improve follow-up rates.

This study is not to assess efficacy or safety of follow-up methods--that has been well established in practice and research. This is to assess choice of follow-up.


Condition or disease Intervention/treatment Phase
Abortion in First Trimester Other: Choice of follow-up option Device: Multi-level pregnancy test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Choice of Modality of Follow up for Medication Abortion
Actual Study Start Date : September 9, 2019
Actual Primary Completion Date : March 13, 2020
Actual Study Completion Date : March 31, 2020

Arm Intervention/treatment
No Intervention: Group 1: Standard of Care
Participants will be asked to complete follow-up in clinic 1-2 weeks following mifepristone administration for an ultrasound and consultation with a provider.
Experimental: Group 2: Flexible Follow-Up
Participants will be offered three follow-up options, including: 1) follow-up in clinic 1-2 weeks following mifepristone administration for an ultrasound and consultation with a provider; 2) repeat serum beta-hCG testing; 3) repeat multi-level pregnancy test strategy
Other: Choice of follow-up option
Participant will be given the opportunity to choose from 3 follow-up options.

Device: Multi-level pregnancy test
The Multi-level pregnancy test (MLPT) strategy involves the use of the MLPT to estimate a pregnant person's baseline hCG range prior to beginning their abortion (i.e. prior to mifepristone administration). A follow-up test is then administered one week later to again estimate the woman's hCG range. A decline in hCG range reliably signifies absence of an ongoing pregnancy. Among clients ≤63 days' LMP at initiation of treatment, this strategy has shown to be highly effective: 100% of clients (n=1487/1487) with a decline in hCG range did not have an ongoing pregnancy and 100% of clients (n=21/21) with an ongoing pregnancy showed steady or increase in hCG range on their follow-up MLPT.
Other Name: dBest




Primary Outcome Measures :
  1. Percent follow-up after medication abortion by group [ Time Frame: 5-14 days following mifepristone administration ]
    To compare rates of follow-up among clients who are instructed to come back to the clinic for in-person ultrasound medication abortion follow-up to clients who are given options for follow-up, including in-person ultrasound, repeat serum beta-hCG and MLPT


Secondary Outcome Measures :
  1. Percent follow-up after medication abortion by follow-up type [ Time Frame: 5-14 days following mifepristone administration ]
    To compare the overall proportion of follow-up completion among clients choosing their preferred method of follow-up (in-person ultrasound, repeat serum beta-hCG, MLPT strategy) (study period) to clients given only the option for in-person follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible for medication abortion <63 days gestational age
  • In general good health
  • English or Spanish speaking competency
  • Willing and able to sign consent forms

Exclusion Criteria:

  • Clients less than 18 years of age.
  • Any client not meeting the inclusion criteria listed above will be excluded from participating in the trial.

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 ClinicalTrials.gov identifier (NCT number): NCT04056637


Locations
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United States, California
Stanford Health Care
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Gynuity Health Projects
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT04056637    
Other Study ID Numbers: 52312
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No data will be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stanford University:
MLPT
multi-level pregnancy test
medication abortion
first trimester abortion
abortion follow-up