Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location (ACTorNOT)
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| ClinicalTrials.gov Identifier: NCT02152696 |
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Recruitment Status :
Completed
First Posted : June 2, 2014
Results First Posted : October 26, 2020
Last Update Posted : December 8, 2020
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Sponsor:
Yale University
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Augusta University
Penn State University
University of California, San Francisco
University of North Carolina
University of Oklahoma
University of Pennsylvania
Information provided by (Responsible Party):
Yale University
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Persistent Pregnancy of Unknown Location Ectopic Pregnancy | Drug: Methotrexate Procedure: Uterine Evacuation Other: Expectant Management | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 255 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location - a Randomized Clinical Trial of Women at Risk for an Ectopic Pregnancy: Active Treatment Versus No Treatment |
| Actual Study Start Date : | July 25, 2014 |
| Actual Primary Completion Date : | August 2019 |
| Actual Study Completion Date : | August 19, 2019 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Expectant Management
Subjects will have their PPUL expectantly managed using serum hCG monitoring.
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Other: Expectant Management
Pregnancy will be expectantly managed using serum hcg monitoring |
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Active Comparator: Uterine evacuation with MTX for some
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.
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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. Procedure: Uterine Evacuation 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. |
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Active Comparator: Empiric treatment with MTX for all
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.
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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. |
Primary Outcome Measures :
- Number of Participants With Uneventful Clinical Resolution of a Pregnancy of Unknown Location Without Change From the Initial Management Strategy [ Time Frame: 6 weeks from randomization ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Female with a persisting pregnancy of unknown location:
- A pregnancy of unknown location is defined as a pregnancy in a woman with a positive pregnancy test but no definitive signs of pregnancy in the uterus or adnexa on ultrasound imaging. A definitive sign of gestation includes ultrasound visualization of a gestational sac with a yolk sac (with or without an embryo) in the uterus or in the adnexa. Ultrasound must be performed within 7 days prior to randomization.
- Persistence of hCG is defined as at least 2 serial hCG values (over 2-14 days), showing < 15% rise per day, or < 50% fall between the first and last value.
- Patient is hemodynamically stable, hemoglobin >10 mg/dL
- Greater than or 18 years of age
Exclusion Criteria:
- Hemodynamically unstable in need of acute treatment
- Most recent hCG > 5000 mIU/mL
- Patient obtaining care in relation to a recently completed pregnancy (delivery, spontaneous or elective abortion)
- Diagnosis of gestational trophoblastic disease
- Subject unwilling or unable to comply with study procedures
- Known hypersensitivity to MTX
- Presence of clinical contraindications for treatment with MTX
- Prior medical or surgical management of this gestation
- Subject unwilling to accept a blood transfusion
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152696
Locations
Show 17 study locations
Sponsors and Collaborators
Yale University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Augusta University
Penn State University
University of California, San Francisco
University of North Carolina
University of Oklahoma
University of Pennsylvania
Investigators
| Study Director: | Esther Eisenberg, MD MPH | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | |
| Study Chair: | Nanette Santoro, MD | University of Colorado, Denver | |
| Principal Investigator: | Kurt Barnhart, MD MSCE | University of Pennsylvania | |
| Study Director: | Michael Diamond, MD | Augusta University | |
| Study Director: | Richard Legro, MD | Penn State University | |
| Study Director: | Marcelle Cedars, MD | University of California, San Francisco | |
| Study Director: | Anne Steiner, MD MPH | University of North Carolina | |
| Study Director: | Karl Hansen, MD PhD | University of Oklahoma | |
| Study Director: | Christos Coutifaris, MD PhD | University of Pennsylvania | |
| Study Director: | Heping Zhang, PhD | Yale University |
Study Documents (Full-Text)
Documents provided by Yale University:
Documents provided by Yale University:
Study Protocol and Statistical Analysis Plan [PDF] September 9, 2019
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Yale University |
| ClinicalTrials.gov Identifier: | NCT02152696 |
| Other Study ID Numbers: |
2000023590 2U10HD055925-06 ( U.S. NIH Grant/Contract ) |
| First Posted: | June 2, 2014 Key Record Dates |
| Results First Posted: | October 26, 2020 |
| Last Update Posted: | December 8, 2020 |
| Last Verified: | November 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | IPD will be shared with other researchers through the NICHD DASH system. It will be available 6 months after publication of the primary results. |
Additional relevant MeSH terms:
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Pregnancy, Ectopic Cardiac Complexes, Premature Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Cardiac Conduction System Disease Pathologic Processes Pregnancy Complications Methotrexate Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents |
Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors |