A Phase 3 interventional study of Methotrexate and Uterine Evacuation in Persistent Pregnancy of Unknown Location and Ectopic Pregnancy, sponsored by Yale University. Completed at 17 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-08.
Sponsored by Yale University · Phase 3, Interventional, and Treatment
This is a randomized controlled trial to compare three currently available management strategies for women with a persisting pregnancy of unknown location (PPUL), which makes them at-risk for ectopic pregnancy. We will recruit hemodynamically stable women with a confirmed PPUL to be randomized to one of three strategies: 1) Uterine evacuation followed by methotrexate (MTX) for some (those that have evidence of a non visualized ectopic pregnancy) 2) Empiric treatment with MTX for all 3) Expectant management. Randomization will be 1:1:1 into these three arms. After randomization, they will be followed and treated clinically as is indicated by the progression of their condition. Primary outcome measures: uneventful decline of hCG to 5 IU/mL.
83 studies on the registry are indexed under Pregnancy, Ectopic; 21 are open to participants now.
This study's enrollment of 255 is above the median of 100 across 43 interventional studies indexed under Pregnancy, Ectopic.
Browse Pregnancy, Ectopic studies →Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will have their PPUL expectantly managed using serum hCG monitoring.
Other: Expectant Management
Subjects will undergo a uterine evacuation. If hCG levels do not sufficiently decrease after the uterine evacuation, the subject will be treated with methotrexate. If hCG levels do sufficiently decrease after the uterine evacuation, no further treatment is required.
Drug: Methotrexate · Procedure: Uterine Evacuation
Subjects will be treated with methotrexate, receiving one dose on day 0 and a subsequent dose on day 4. Additional doses will be administered as needed based on hCG levels.
Drug: Methotrexate
Two Dose Protocol: The patient will receive the first dose of MTX 50mg/m2 on treatment day 0. She will receive a second dose of MTX 50mg/m2 on treatment day 4 and a serum hCG level will be drawn. Subsequent doses of MTX will be administered based on hCG levels.
Uterine evacuation or dilation and curettage. At the clinician's discretion, this can be performed using local anesthesia, sedation or general anesthesia and can use a manual or electrical evacuation.
Pregnancy will be expectantly managed using serum hcg monitoring
Number of Participants With Uneventful Clinical Resolution of a Pregnancy of Unknown Location Without Change From the Initial Management Strategy
The primary outcome measure in each of each 3 treatment arm is the uneventful clinical resolution of a PPUL without change in treatment from the initial management strategy.
Time frame: 6 weeks from randomization
| Milestone | Expectant Management | Uterine Evacuation With MTX for Some | Empiric Treatment With MTX for All |
|---|---|---|---|
| Started | 86 | 87 | 82 |
| Completed | 86 | 86 | 81 |
| Not completed | 0 | 1 | 1 |
The primary outcome measure in each of each 3 treatment arm is the uneventful clinical resolution of a PPUL without change in treatment from the initial management strategy.
| Participants | Expectant Management | Uterine Evacuation With MTX for Some | Empiric Treatment With MTX for All |
|---|---|---|---|
| Number of Participants With Uneventful Clinical Resolution of a Pregnancy of Unknown Location Without Change From the Initial Management Strategy | 31 | 42 | 45 |
Collected over The period of time over which the adverse events were collected is: from the initiation of the study procedures to the end of the study treatment follow-up, which is about an average of 42 days following the last administration of study treatment.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Expectant Management | 0/86 (0%) | 2/86 (2.3%) | 44/86 (51.2%) |
| Uterine Evacuation With MTX for Some | 0/87 (0%) | 2/87 (2.3%) | 53/87 (60.9%) |
| Empiric Treatment With MTX for All | 0/82 (0%) | 0/82 (0%) | 46/82 (56.1%) |
| Event | Expectant Management | Uterine Evacuation With MTX for Some | Empiric Treatment With MTX for All |
|---|---|---|---|
| SalpingectomyPregnancy, puerperium and perinatal conditions | 2/86 | 0/87 | 0/82 |
| HospitalizationPregnancy, puerperium and perinatal conditions | 0/86 | 1/87 | 0/82 |
| Right ruptured ectopic pregnancyPregnancy, puerperium and perinatal conditions | 0/86 | 1/87 | 0/82 |
| Event | Expectant Management | Uterine Evacuation With MTX for Some | Empiric Treatment With MTX for All |
|---|---|---|---|
| One or more adverse eventGeneral disorders | 44/86 | 53/87 | 46/82 |
| Vaginal bleedingSurgical and medical procedures | 38/86 | 46/87 | 39/82 |
| Pelvic PainReproductive system and breast disorders | 37/86 | 42/87 | 38/82 |
| FatigueGeneral disorders | 38/86 | 38/87 | 36/82 |
| NauseaGastrointestinal disorders | 22/86 | 32/87 | 31/82 |
| HeadachesNervous system disorders | 31/86 | 25/87 | 27/82 |
| Loss of AppetiteGastrointestinal disorders | 25/86 | 28/87 | 23/82 |
| Dizziness or weaknessGeneral disorders | 18/86 | 27/87 | 17/82 |
| DiarrheaGastrointestinal disorders | 9/86 | 21/87 | 13/82 |
| Shoulder or back painGeneral disorders | 14/86 | 18/87 | 12/82 |
| Age, Continuous(years) | Expectant Management | Uterine Evacuation With MTX for Some | Empiric Treatment With MTX for All | Total |
|---|---|---|---|---|
| Mean | 32.1 ± 5.6 | 31.2 ± 5.9 | 31.5 ± 5.7 | 31.6 ± 5.7 |
| Sex: Female, Male(Participants) | Expectant Management | Uterine Evacuation With MTX for Some | Empiric Treatment With MTX for All | Total |
|---|---|---|---|---|
| Female | 86 | 87 | 82 | 255 |
| Male | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Expectant Management | Uterine Evacuation With MTX for Some | Empiric Treatment With MTX for All | Total |
|---|---|---|---|---|
| Hispanic or Latino | 3 | 8 | 6 | 17 |
| Not Hispanic or Latino | 80 | 75 | 74 | 229 |
| Unknown or Not Reported | 3 | 4 | 2 | 9 |
| Race (NIH/OMB)(Participants) | Expectant Management | Uterine Evacuation With MTX for Some | Empiric Treatment With MTX for All | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 3 | 10 | 4 | 17 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 37 | 33 | 32 | 102 |
| White | 41 | 40 | 39 | 120 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 5 | 4 | 7 | 16 |
| Region of Enrollment(Participants) | Expectant Management | Uterine Evacuation With MTX for Some | Empiric Treatment With MTX for All | Total |
|---|---|---|---|---|
| United States | 86 | 87 | 82 | 255 |
| Estimated gestational age - week(weeks) | Expectant Management | Uterine Evacuation With MTX for Some | Empiric Treatment With MTX for All | Total |
|---|---|---|---|---|
| Mean | 6.4 ± 1.8 | 6.9 ± 1.9 | 6.7 ± 2.0 | 6.7 ± 1.9 |
| First hCG value at screening (mIU/ml)(mIU/ml) | Expectant Management | Uterine Evacuation With MTX for Some | Empiric Treatment With MTX for All | Total |
|---|---|---|---|---|
| Mean | 661.2 ± 688.6 | 561.9 ± 702.5 | 633.3 ± 695.8 | 618.3 ± 694.2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD will be shared with other researchers through the NICHD DASH system. It will be available 6 months after publication of the primary results.
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Studies of the drug tested here: Methotrexate