Evidence map›Paper›PMID 30243810›Full record

ArticleContemporary clinical trials2018

Optimal treatment for women with a persisting pregnancy of unknown location, a randomized controlled trial: The ACT-or-NOT trial.

Kurt T Barnhart, Mary D Sammel, Mary Stephenson, Jared Robins, Karl R Hansen, Wahid A Youssef, Nanette Santoro, Esther Eisenberg, Heping Zhang, NICHD Cooperative Reproductive Medicine Network

Open access · greenAbstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.1field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 7 institutions in 1 country.

Kurt T BarnhartDepartment of Obstetrics and Gynecology, University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, United States; Department of Biostatistics and Epidemiology, University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, United States. Electronic address: kbarnhart@obgyn.upenn.edu.
Mary D SammelDepartment of Biostatistics and Epidemiology, University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, United States.
Mary StephensonDepartment of Obstetrics and Gynecology, University of Illinois at Chicago, Chicago, IL, United States.
Jared RobinsDivision of Reproductive Endocrinology and Infertility, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.
Karl R HansenDepartment of Obstetrics and Gynecology, University of Oklahoma Health Sciences, Oklahoma City, OK, United States.
Wahid A YoussefDepartment of Obstetrics and Gynecology, University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, United States.
Nanette SantoroDepartment of Obstetrics and Gynecology, University of Colorado, Denver, United States.
Esther EisenbergReproductive Sciences Branch, Eunice Kennedy Shriver NICHD, Rockville, MD, United States.
Heping ZhangDepartment of Biostatistics, Yale University School of Public Health, New Haven, CT, United States.
NICHD Cooperative Reproductive Medicine Network
University of Pennsylvania · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USNorthwestern University · USUniversity of Colorado Denver · USUniversity of Illinois Chicago · USUniversity of Oklahoma Health Sciences Center · USYale University · US

Funding

Data Coordination Center for the RMNU10HD055925 · NICHD · YALE UNIVERSITY · PI ZHANG, HEPING · 2007 to 2019
$39.2M
COOPERATIVE MULTICENTER REPRODUCTIVE MEDICINE NETWORKU10HD027049 · NICHD · UNIVERSITY OF PENNSYLVANIA · PI COUTIFARIS, CHRISTOS · 1990 to 2017
$5.2M
Development of a serum biosignature for ectopic pregnancy.R01HD076279 · NICHD · UNIVERSITY OF PENNSYLVANIA · PI BARNHART, KURT T · 2014 to 2018
$3.4M
The Clinical Research/Reproductive Scientist Training Program (CREST)R25HD075737 · NICHD · UNIVERSITY OF COLORADO DENVER · PI Nanette F. Santoro · 2013 to 2026
$2.3M
Luteal Progesterone Supplementation in Clomiphene Citrate-IUI CyclesU10HD077680 · NICHD · UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR · PI HANSEN, KARL RICHARD · 2013 to 2017
$1.5M
NICHD NIH HHS R01 HD076279NICHD NIH HHS R25 HD075737NICHD NIH HHS U10 HD027049NICHD NIH HHS U10 HD055925NICHD NIH HHS U10 HD077680
6 · The paper itself

Abstract

objectivePregnancy of unknown location (PUL) is not a diagnosis but a transient state used to classify a woman when she has a positive pregnancy test without definitive evidence of an intra-uterine or extra-uterine pregnancy on transvaginal ultrasonography. Management of a persisting PUL varies substantially, including expectant or active management. Active management can include uterine cavity evacuation or systemic administration of methotrexate. To date, no consensus has been reached on whether either management strategy is superior or non-inferior to the other.

designRandomized controlled trial.

settingAcademic medical centers. PATIENTS: We plan to randomize 276 persisting PUL-diagnosed women who are 18 years or older from Reproductive Medicine Network clinics and additional interested sites, all patients will be followed for 2 years for fertility and patient satisfaction outcomes.

interventionsRandomization will be 1:1:1 ratio between expectant management, uterine evacuation and empiric use of methotrexate. After randomization to initial management plan, all patients will be followed by their clinicians until resolution of the PUL. The clinician will determine whether there is a change in management, based on clinical symptoms, and/or serial human chorionic gonadotropin (hCG) concentrations and/or additional ultrasonography. MAIN OUTCOME: The primary outcome measure in each of the 3 treatment arms is the uneventful clinical resolution of a persistent PUL without change from the initial management strategy. Secondary outcome measures include: number of ruptured ectopic pregnancies, number and type of re-interventions (additional methotrexate injections or surgical procedures), treatment complications, adverse events, number of visits, time to resolution, patient satisfaction, and future fertility.

conclusionThis multicenter randomized controlled trial will provide guidance for evidence-based management for women who have persisting pregnancy of unknown location.

Indexed as

Abortifacient Agents, NonsteroidalAbortion, SpontaneousDilatation and CurettageMethotrexatePregnancy, EctopicWatchful WaitingChorionic GonadotropinDiagnosis, DifferentialFemaleHumansMulticenter Studies as TopicPregnancyRandomized Controlled Trials as TopicUltrasonographyAbortifacient Agents, NonsteroidalChorionic GonadotropinMethotrexateBiomarkersEctopic PregnancyMethotrexatePULUterine Evacuation

Identifiers

PMID30243810
PMCPMC6231403
OpenAlexW2892048436

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.