du.sePublikationer
Ändra sökning
RefereraExporteraLänk till posten
Permanent länk

Direktlänk
Referera
Referensformat
  • apa
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • chicago-author-date
  • chicago-note-bibliography
  • Annat format
Fler format
Språk
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Annat språk
Fler språk
Utmatningsformat
  • html
  • text
  • asciidoc
  • rtf
Evaluating the safety, effectiveness and acceptability of treatment of incomplete second-trimester abortion using misoprostol provided by midwives compared with physicians: study protocol for a randomized controlled equivalence trial
Högskolan Dalarna, Akademin Utbildning, hälsa och samhälle, Omvårdnad. Karolinska institutet.ORCID-id: 0000-0002-8947-2949
Visa övriga samt affilieringar
2019 (Engelska)Ingår i: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 20, nr 1, artikel-id 376Artikel i tidskrift (Refereegranskat) Published
Abstract [en]

BACKGROUND: A large proportion of abortion-related mortality and morbidity occurs in the second trimester of pregnancy. The Uganda Ministry of Health policy restricts management of second-trimester incomplete abortion to physicians who are few and unequally distributed, with most practicing in urban regions. Unsafe and outdated methods like sharp curettage are frequently used. Medical management of second-trimester post-abortion care by midwives offers an advantage given the difficulty in providing surgical management in low-income settings and current health worker shortages. The study aims to assess the safety, effectiveness and acceptability of treatment of incomplete second-trimester abortion using misoprostol provided by midwives compared with physicians.

METHODS: A randomized controlled equivalence trial implemented at eight hospitals and health centers in Central Uganda will include 1192 eligible women with incomplete abortion of uterine size > 12 weeks up to 18 weeks. Each participant will be randomly assigned to undergo a clinical assessment and treatment by either a midwife (intervention arm) or a physician (control arm). Enrolled participants will receive 400 μg misoprostol administered sublingually every 3 h up to five doses within 24 h at the health facility until a complete abortion is confirmed. Women who do not achieve complete abortion within 24 h will undergo surgical uterine evacuation. Pre discharge, participants will receive contraceptive counseling and information on what to expect in terms of side effects and signs of complications, with follow-up 14 days later to assess secondary outcomes. Analyses will be by intention to treat. Background characteristics and outcomes will be presented using descriptive statistics. Differences between groups will be analyzed using risk difference (95% confidence interval) and equivalence established if this lies between the predefined range of - 5% and + 5%. Chi-square tests will be used for comparison of outcome and t tests used to compare mean values. P ≤ 0.05 will be considered statistically significant.

DISCUSSION: Our study will provide evidence to inform national and international policies, standard care guidelines and training program curricula on treatment of second-trimester incomplete abortion for improved access.

TRIAL REGISTRATION: ClinicalTrials.gov, NCT03622073 . Registered on 9 August 2018.

Ort, förlag, år, upplaga, sidor
2019. Vol. 20, nr 1, artikel-id 376
Nyckelord [en]
Contraception, Incomplete abortion, Misoprostol, Post abortion care, Second trimester, Task sharing, Uganda
Nationell ämneskategori
Hälsovetenskaper
Forskningsämne
Hälsa och välfärd
Identifikatorer
URN: urn:nbn:se:du-30380DOI: 10.1186/s13063-019-3490-5ISI: 000472522500003PubMedID: 31227019Scopus ID: 2-s2.0-85068536981OAI: oai:DiVA.org:du-30380DiVA, id: diva2:1329911
Tillgänglig från: 2019-06-25 Skapad: 2019-06-25 Senast uppdaterad: 2019-07-23Bibliografiskt granskad

Open Access i DiVA

fulltext(1255 kB)52 nedladdningar
Filinformation
Filnamn FULLTEXT01.pdfFilstorlek 1255 kBChecksumma SHA-512
8d9bf756cd039f69d99dce6e5281888b488ec6688c7239ef2c187611eda7d58628a0d816df7f36c03dee13295a48e9a55afa68fdae10e53b2014ecc799f9586b
Typ fulltextMimetyp application/pdf

Övriga länkar

Förlagets fulltextPubMedScopus

Personposter BETA

Klingberg-Allvin, Marie

Sök vidare i DiVA

Av författaren/redaktören
Klingberg-Allvin, Marie
Av organisationen
Omvårdnad
I samma tidskrift
Trials
Hälsovetenskaper

Sök vidare utanför DiVA

GoogleGoogle Scholar
Totalt: 52 nedladdningar
Antalet nedladdningar är summan av nedladdningar för alla fulltexter. Det kan inkludera t.ex tidigare versioner som nu inte längre är tillgängliga.

doi
pubmed
urn-nbn

Altmetricpoäng

doi
pubmed
urn-nbn
Totalt: 73 träffar
RefereraExporteraLänk till posten
Permanent länk

Direktlänk
Referera
Referensformat
  • apa
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • chicago-author-date
  • chicago-note-bibliography
  • Annat format
Fler format
Språk
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Annat språk
Fler språk
Utmatningsformat
  • html
  • text
  • asciidoc
  • rtf