Trial Outcomes & Findings for RCT for Women With a Persisting Pregnancy of Unknown Location (NCT NCT01800162)

Results Overview

Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

2 participants

Primary outcome timeframe

Outcome will be assessed within 6 weeks of randomization

Results posted on

2017-12-29

Participant Flow

Recruitment for the study has closed at both study sites, The University of Pennsylvania and Greenville.

Subjects must be 18 years or older. Subject must have a positive pregnancy test but no signs of pregnancy visualized in the uterus or adnexa on ultrasound? Subject must have at least three serial hCG values over the past 4-14 days or two serial hCG values over the past 7-14 days. Subject must be hemodynamically stable with a hemoglobin \>10mg/dL.

Participant milestones

Participant milestones
Measure	Uterine Evacuation, Then 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. 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: 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.	Expectant Management Subjects will have their PPUL expectantly managed using serum hCG monitoring. Expectant Management: Pregnancy will be expectantly managed using serum hcg monitoring.
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

RCT for Women With a Persisting Pregnancy of Unknown Location

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Uterine Evacuation, Then MTX for Some n=1 Participants 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. 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: 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.	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. 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.	Expectant Management n=1 Participants Subjects will have their PPUL expectantly managed using serum hCG monitoring. Expectant Management: Pregnancy will be expectantly managed using serum hcg monitoring.	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment Netherlands	0 participants n=5 Participants	—	1 participants n=5 Participants	1 participants n=4 Participants
Region of Enrollment United States	1 participants n=5 Participants	—	0 participants n=5 Participants	1 participants n=4 Participants
Gestational Age	14 weeks n=5 Participants	—	7 weeks n=5 Participants	21 weeks n=4 Participants

PRIMARY outcome

Timeframe: Outcome will be assessed within 6 weeks of randomization

Population: Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.

Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Outcome will be assess within 6 weeks of randomization

Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Outcomes include: * number of interventions beyond that of intended initial strategy in each group * additional number of MTX injections * additional surgical procedures * uterine evacuation (or dilation and curettage) * laparoscopy * laparotomy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 42 days after the last dose of study medication

Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.

Outcome measures

Outcome data not reported

Adverse Events

Uterine Evacuation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Expectant Management

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kurt Barnhart

University of Pennsylvania

Phone: 215-662-2974

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place