Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location
| Status: | Recruiting | 
|---|---|
| Conditions: | Cardiology | 
| Therapuetic Areas: | Cardiology / Vascular Diseases | 
| Healthy: | No | 
| Age Range: | 18 - Any | 
| Updated: | 2/22/2019 | 
| Start Date: | May 2014 | 
| End Date: | August 2019 | 
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
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.
			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.
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
We found this trial at
    18
    sites
	
		Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...  
  
  Click here to add this to my saved trials
	 
  
									60 Crittenden Blvd # 70
Rochester, New York 14642
	
			Rochester, New York 14642
(585) 275-2121 
							 
					Principal Investigator: Kathy Hoeger, MD
			
						
										Phone: 585-273-2995
					
		University of Rochester The University of Rochester is one of the country's top-tier research universities....  
  
  Click here to add this to my saved trials
	 
  
									201 Presidents Circle
Salt Lake City, Utah 84108
	
			Salt Lake City, Utah 84108
801) 581-7200 
							 
					Principal Investigator: Erica Johnstone, MD
			
						
										Phone: 801-581-7038
					
		University of Utah Research is a major component in the life of the U benefiting...  
  
  Click here to add this to my saved trials
	 
  
									4202 E Fowler Ave
Tampa, Florida 33620
	
			Tampa, Florida 33620
(813) 974-2011
							 
					Principal Investigator: Shayne Plosker, MD
			
						
										Phone: 813-259-0655
					
		University of South Florida The University of South Florida is a high-impact, global research university...  
  
  Click here to add this to my saved trials
	 
  
								Augusta, Georgia 30912			
	
			
					Principal Investigator: Michael Diamond, MD
			
						
										Phone: 706-721-9680
					Click here to add this to my saved trials
	 
  
								Chapel Hill, North Carolina 27599			
	
			(919) 962-2211 
							 
					Principal Investigator: Anne Steiner, MD, MPH
			
						
										Phone: 919-843-8246
					
		Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...  
  
  Click here to add this to my saved trials
	 
  
								Charlotte, North Carolina 28204			
	
			
					Principal Investigator: Rebecca Usadi, MD
			
						
										Phone: 704-355-3834
					Click here to add this to my saved trials
	 
  
									 2035 W Taylor St
Chicago, Illinois
	
			Chicago, Illinois
(312) 996-4350
							 
					Principal Investigator: Mary Stephenson, MD
			
						
										Phone: 312-355-4559
					
		University of Illinois at Chicago A major research university in the heart of one of...  
  
  Click here to add this to my saved trials
	 
  
									303 East Superior Street
Chicago, Illinois 60611
	
			
					Chicago, Illinois 60611
Principal Investigator: Jared Robins, MD
			
						
										Phone: 312-926-8244
					Click here to add this to my saved trials
	 
  
								Denver, Colorado 80204			
	
			
					Principal Investigator: Meredith Alston, MD
			
						
										Phone: 303-602-9086
					Click here to add this to my saved trials
	 
  
								Greenville, South Carolina 29615			
	
			
					Principal Investigator: Benjie Mills, MD
			
						
										Phone: 864-455-6203
					Click here to add this to my saved trials
	 
  
								Hershey, Pennsylvania 17033			
	
			
					Principal Investigator: Richard Legro, MD
			
						
										Phone: 717-531-3692
					Click here to add this to my saved trials
	 
  
								New Haven, Connecticut 6520			
	
			(203) 432-4771 
							 
					Principal Investigator: Linda Fan, MD
			
						
										Phone: 203-737-4660
					
		Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...  
  
  Click here to add this to my saved trials
	 
  
									1100 N. Lindsay
Oklahoma City, Oklahoma 73104
	
			Oklahoma City, Oklahoma 73104
(405) 271-4000
							 
					Principal Investigator: Karl Hansen, MD, PhD
			
						
										Phone: 405-271-1616
					
		University of Oklahoma The OU Health Sciences Center is composed of seven health-related colleges located...  
  
  Click here to add this to my saved trials
	 
  
									3451 Walnut St
Philadelphia, Pennsylvania 19104
	
			Philadelphia, Pennsylvania 19104
1 (215) 898-5000 
							 
					Phone: 215-615-4890
					
		Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...  
  
  Click here to add this to my saved trials
	 
  
								Saint Louis, Missouri 63110			
	
			
					Principal Investigator: Emily Jungheim, MD
			
						
										Phone: 314-286-2458
					Click here to add this to my saved trials
	 
  
								San Francisco, California 94143			
	
			
					Principal Investigator: Marcelle Cedars, MD
			
						
										Phone: 415-353-4305
					Click here to add this to my saved trials
	 
  
								Southfield, Michigan 48034			
	
			
					Principal Investigator: Puscheck Elizabeth, MD
			
						
										Phone: 248-352-8200
					Click here to add this to my saved trials
	 
  