Evidence map›Paper›PMID 33930380›Full record

Trial reportContraception2021

The effect of mifepristone pretreatment on bleeding and pain during medical management of early pregnancy loss.

Andrea H Roe, Arden McAllister, Anne N Flynn, Brandon Martin, Eva Jiang, Nathanael Koelper, Courtney A Schreiber

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Contraception, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.8field-weighted citation impact, top 27% 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

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. 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

7 authors at 1 institution in 1 country.

Andrea H RoeDepartment of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States 19104. Electronic address: andrea.roe@uphs.upenn.edu.
Arden McAllisterDepartment of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States 19104.
Anne N FlynnDepartment of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States 19104.
Brandon MartinDepartment of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States 19104.
Eva JiangDepartment of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States 19104.
Nathanael KoelperDepartment of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States 19104.
Courtney A SchreiberDepartment of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States 19104.
University of Pennsylvania · US

Funding

Comparative Effectiveness of Pregnancy Failure Management Regimens (Pre-Fai-R)R01HD071920 · NICHD · UNIVERSITY OF PENNSYLVANIA · PI SCHREIBER, COURTNEY A. · 2013 to 2017
$2.8M
NICHD NIH HHS R01 HD071920
6 · The paper itself

Abstract

objectivesTo compare participant-reported bleeding and pain with two medication regimens for early pregnancy loss (EPL). STUDY

designWe performed a secondary analysis of a randomized trial in which participants took either mifepristone 200 mg orally followed by misoprostol 800 mcg vaginally 24 hours later or misoprostol alone for medical management of EPL. Participants reported bleeding and pain (Numeric Pain Rating Scale, NPRS, 0-10) with daily paper diaries and at study visits on trial days 3, 8, and 30. We used, Fisher's exact, Pearson chi-square, Wilcoxon rank sum, and Student's t-tests to compare onset, duration, and severity of bleeding and pain symptoms between trial arms after misoprostol administration.

resultsAmong 291 participants who submitted diary data, 143 received mifepristone pretreatment. A larger proportion of this group reported moderate or heavy bleeding on trial day 2, the day of misoprostol administration, compared with those who did not receive pretreatment (73% vs 47%, p < 0.01). Between days 4 and 8, more mifepristone-pretreatment participants reported mild or no bleeding, compared with the misoprostol-only arm (78% vs 61%, p < 0.01). Average pain score for trial days 2-4 was higher for the pretreatment group compared with the misoprostol-only group (6.9 vs 6.0, p = 0.01), and there was a trend toward shorter total duration of pain (15 vs 19 hours, p = 0.08). These differences remained after controlling for treatment success across arms.

conclusionsMifepristone pretreatment increased the severity of pain but not bleeding and resulted in a shorter trajectory of symptoms during medical management of EPL. IMPLICATIONS: Mifepristone pretreatment decreases the duration of heavy bleeding and there was a trend toward decreased duration of pain during medical management of miscarriage, indicating that this medication improves the efficiency, in addition to the efficacy, of this treatment.

Indexed as

Abortifacient Agents, NonsteroidalAbortifacient Agents, SteroidalAbortion, InducedAbortion, SpontaneousMisoprostolFemaleHumansMifepristonePainPregnancyAbortifacient Agents, NonsteroidalAbortifacient Agents, SteroidalMifepristoneMisoprostolBleedingEarly pregnancy lossMifepristoneMiscarriageMisoprostolPain

Identifiers

PMID33930380
PMCPMC10302372
OpenAlexW3157667172

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.