| Registry | NCT04026789, acronym MAPUL |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 57 (Estimated) |
| Sponsor | Planned Parenthood League of Massachusetts (Other) |
| Conditions | Pregnancy Related |
| Interventions | Same-day-start, Delay-for-diagnosis (Other) |
| Dates | start 2019-07-22, primary completion 2021-07-17 (estimated), completion 2021-07-31 (estimated), first posted 2019-07-19, last updated 2020-10-05 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Pregnancy Related All trials of Same-day-start All trials of Delay-for-diagnosis
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Same-day-start | Active comparator | Other: 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 | Active comparator | Other: 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 |
Sex: Female, ages: 18 Years to any, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| PPLM | Boston, Massachusetts | United States | Recruiting |