Pregnancy Related
Conditions
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.
Interventions
OTHERSame-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
OTHERDelay-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
Sponsors
Planned Parenthood League of Massachusetts
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
randomized controlled trial (plus prospective cohort for those interested in participation but unwilling to be randomized)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to completed abortion | through study completion, an average of two weeks | Time to completed abortion as defined by the number of days between initial ultrasound diagnosis of PUL to the diagnostic test that confirms complete abortion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with complete expulsion of pregnancy without surgical intervention | 14 days after initiation of medical abortion | Efficacy of medical abortion, defined as number of participants with complete expulsion of pregnancy without surgical intervention |
| Time to diagnosis of pregnancy outcome | Within 2 weeks of identification of pregnancy of unknown location on ultrasound | Number of days between initial ultrasound diagnosis of pregnancy of unknown location and diagnosis of pregnancy outcome, with options including intrauterine pregnancy, ectopic pregnancy, or early pregnancy loss |
| Rate of ectopic pregnancy | Within 2 weeks of identification of pregnancy of unknown location on ultrasound | Rate of ectopic pregnancy among entire study population |
| Percent of participants who complete follow-up and confirm complete abortion | Within 1 month of identification of pregnancy of unknown location on ultrasound | Percent of participants who adhered to recommended follow-up plan and confirmed a complete abortion through ultrasound or hCG |
Countries
United States
Contacts
Primary ContactPrincipal Investigator
Outcome results
None listed