Choice of Modality of Follow up for Medication Abortion

Abortion in First Trimester Clinical Trial

Official title:

Choice of Modality of Follow up for Medication Abortion

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04056637
• Other study ID #: 52312
• Status: Terminated
• Phase: N/A
• Start date: September 9, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: May 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: March 31, 2020
• Est. primary completion date: March 13, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abortion in First Trimester

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford Health Care	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Gynuity Health Projects

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent follow-up after medication abortion by group	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	5-14 days following mifepristone administration
Secondary	Percent follow-up after medication abortion by follow-up type	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	5-14 days following mifepristone administration