AMIPROM - A randomised controlled trial of amnioinfusion versus expectant management in very early preterm premature rupture of membranes

Roberts D, Vause S, Martin W, Green P, Walkinshaw S, Bricker L, Beardsmore C, Nj Shaw B, McKay A, Skotny G, Williamson P, Alfirevic Z
Record ID 32010000342
English
Authors' objectives: The AI in preterm premature rupture of membranes (AMIPROM) pilot study was conducted to assess the feasibility of recruitment, the methods for conduct and the retention through to long-term follow-up of participants with very early rupture of amniotic membranes (between 16 and 24 weeks of pregnancy). It was also performed to assess outcomes and collect data to inform a larger, more definitive, clinical trial.
Authors' recommendations: This pilot study found no major differences in maternal, perinatal or pregnancy outcomes. The study was not designed to show a difference between the arms and the number of survivors was too small to draw any conclusions about long-term outcomes. It does signal, however, that a larger, definitive, study to evaluate AI for improvement in healthy survival is indicated. The results suggest that, with appropriate funding, such a study is feasible. A larger, definitive, study with full health economic analysis and patient perspective assessment is required to show whether AI can improve the healthy survivor rate.
Details
Project Status: Completed
Year Published: 2014
URL for published report: http://www.journalslibrary.nihr.ac.uk/hta/hta18210/#/abstract
URL for additional information: http://www.journalslibrary.nihr.ac.uk/hta/volume-18/issue-21#hometab4
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: England, United Kingdom
MeSH Terms
  • Amniotic Fluid
  • Pregnancy
  • Pregnancy Outcome
Contact
Organisation Name: NIHR Health Technology Assessment programme
Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK
Contact Name: journals.library@nihr.ac.uk
Contact Email: journals.library@nihr.ac.uk
Copyright: <p>2014 Queen's Printer and Controller of HMSO</p>
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.