Evidence map›Paper›PMID 35441854›Full record

Trial reportInternational urogynecology journal2022

A pilot randomized controlled trial of vaginal estrogen on postpartum atrophy, perineal pain, and sexual function.

Pamela E Smith, Eric M McLaughlin, Lopa K Pandya, Erinn M Hade, Courtney D Lynch, Catherine O Hudson

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in International urogynecology journal, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 22% 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, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. The use of topical vaginal estrogens in postpartum women: A systematic review.Acta obstetricia et gynecologica Scandinavica · 2026
    Pooled it
  2. Article
  3. Article
  4. Review
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

6 authors at 5 institutions in 1 country.

Pamela E SmithKaiser Permanente, Central Valley Area, 4601 Dale Road, Modesto, CA, 95356, USA. pamela.e1.smith@kp.org.
Eric M McLaughlinDepartment of Biomedical Informatics, Center for Biostatistics, The Ohio State University, 200 Lincoln Tower, 1800 Cannon Drive, Columbus, OH, 43210, USA.
Lopa K PandyaFemale Pelvic Medicine and Reconstructive Surgery, University of Illinois at Chicago, 820 S Wood St, CSN (MC808), Chicago, IL, 60612, USA.
Erinn M HadeDepartment of Population Health, Division of Biostatistics, NYU Grossman School of Medicine, 180 Madison Ave, Suite 5-53, New York, NY, 10016, USA.
Courtney D LynchDepartment of Obstetrics & Gynecology, The Ohio State University, 395 W 12th Ave, Room 580, Columbus, OH, 43210, USA.
Catherine O HudsonWellstar Urogynecology, 4900 Ivey Rd NW, Suite 1320, Acworth, GA, 37363, USA.
The Ohio State University · USKaiser Permanente · USNew York University · USUniversity of Illinois Chicago · USWellStar Health System · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introduction and hypothesisVulvovaginal symptoms following perineal laceration may be worsened by atrophy related to decreased estrogen. Our objective was to evaluate the effect of local estrogen therapy in this setting.

methodsWe conducted a single-center, pilot, randomized, placebo-controlled trial of local estradiol in primiparous women with a second-degree or greater perineal laceration following a term vaginal delivery. Participants were randomized to twice weekly estradiol or placebo cream from delivery through 3 months postpartum. The primary outcome was a validated measure of vulvovaginal symptoms at 12 weeks postpartum. Secondary outcomes included measures of perineal pain, quality of life, sexual function, ease of use, likelihood of continued use, and adverse events.

resultsWe planned to enroll 70 women; however, due to human subjects research restrictions related to the COVID-19 pandemic, enrollment was stopped early. A total of 59 women were randomized, 31 to the estradiol group and 28 to the placebo group. Nearly all participants (95%) were followed through 12 weeks with suggestion of marginal improvement in Vulvar Assessment Scale scores [-0.10; 90% CI = (-0.20, 0.01)] in those randomized to estradiol compared to placebo. Local estradiol was not associated with improvement in other measures, and only one non-serious adverse event was observed.

conclusionsIn primiparous women with a perineal laceration, use of local estradiol showed minimal clinical benefit in vulvovaginal atrophy and related symptoms but appears to be acceptable and safe for postpartum use. Larger adequately powered trials enrolling a diverse group of postpartum women are needed to affirm these findings.

Indexed as

COVID-19LacerationsAtrophyEstradiolEstrogensFemaleHumansPandemicsPelvic PainPilot ProjectsPostpartum PeriodQuality of LifeEstradiolEstrogensPelvic floorPostpartum atrophyVaginal estrogen

Identifiers

PMID35441854
PMCPMC9020152
OpenAlexW4224285788

What OpenQuestion holds

Textmetadata
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.