Recruiting

Medication Abortion

Sponsor:

Planned Parenthood League of Massachusetts

Code:

NCT04026789

Conditions

Pregnancy Related

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Same-day-start

Delay-for-diagnosis

Study Details

Brief summary:

The purpose of this study is to compare time to completed abortion between two protocols for patients seeking medication abortion - same-day start versus delay-for-diagnosis - in the setting of asymptomatic, low-risk, pregnancy of unknown location.

Conditions

Pregnancy Related

Study ID

NCT04026789

Start date

Jul 22, 2019

Status verified date

Oct, 2020

Completion date

Jul 31, 2021

Anticipated

Primary completion date

Jul 17, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Patients with an undesired pregnancy of less than or equal to 42 days gestation based on last menstrual period (LMP) who present to Planned Parenthood League of Massachusetts (PPLM)'s Greater Boston Health Center seeking medication abortion will be considered for study participation.

Inclusion criteria:

  • Positive urine or serum hCG test
  • No evidence of gestational sac on transvaginal ultrasound
  • Desire for medication abortion as method of pregnancy termination

Exclusion criteria:

  • Ineligible for medication abortion at PPLM based on current PPLM clinical guidelines
  • Reasonable clinical suspicion for ectopic or molar pregnancy, such as abnormal or concerning ultrasound findings
  • High risk for ectopic pregnancy, such as prior ectopic pregnancy, history of tubal surgery, concurrent intrauterine device in place during this pregnancy
  • Exhibiting symptoms of possible ectopic, such as vaginal bleeding or abdominal pain
  • LMP > 42 days or unknown LMP
  • Age less than 18 years
  • Prior participation in this study
  • Anticipated inability to present for scheduled follow-up visits

Study Design

Enrollment

57 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Same-day-start

Patients seeking medication abortion who are shown to have an asymptomatic, low-risk pregnancy of unknown location who are randomized to same-day start will have their medication abortion initiated on the day that they present for services while simultaneously ruling out ectopic pregnancy with serial hcg testing

active comparator: Delay-for-diagnosis

Patients seeking medication abortion who are shown to have an asymptomatic, low-risk pregnancy of unknown location who are randomized to delay-for-diagnosis will first have ectopic pregnancy ruled out with serial hcg and ultrasounds prior to initiating medication abortion

Interventions

Same-day-start

Patients seeking medication abortion who are shown to have an asymptomatic, low-risk pregnancy of unknown location who are randomized to same-day start will have their medication abortion initiated on the day that they present for services while simultaneously ruling out ectopic pregnancy with serial hcg testing

Delay-for-diagnosis

Patients seeking medication abortion who are shown to have an asymptomatic, low-risk pregnancy of unknown location who are randomized to delay-for-diagnosis will first have ectopic pregnancy ruled out with serial hcg and ultrasounds prior to initiating medication abortion

Primary outcome measure

  • Time to completed abortion [ Time Frame: through study completion, an average of two weeks ]

Central Contacts and Locations

Central contacts

Principal Investigator

6176161600research@pplm.org

Locations

PPLM

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Research Manager

617-616-1600research@pplm.org

More Information

Sponsor

Planned Parenthood League of Massachusetts

Last update posted

Oct 5, 2020

Last verified

Oct, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Planned Parenthood League of Massachusetts on 2020-10-05.