Plain English Summary
Background and study aims
Preterm premature rupture of membranes (PPROM) is a condition where a pregnant woman’s waters break very early in the pregnancy (i.e., before 37 weeks). The amniotic fluid, which surrounds and protects the fetus in the womb, leaks out through the vagina. If PPROM occurs, there is an increased risk of premature delivery and its associated complications, including death of the premature infant. The aim of this study is to find out whether intervention for PPROM can improve outcomes.
Who can participate?
Pregnant women with preterm premature rupture of membranes
What does the study involve?
Participants are randomly allocated to either undergo amnioinfusion (putting fluid back into the womb) or expectant management (watch and wait). The treatment takes place in hospital as an outpatient, although sometimes admission to hospital may be necessary. In the amnioinfusion group, amniotic fluid is replaced weekly until 34 weeks if needed. In the expectant management group, the pregnancy is monitored by weekly scans but no fluid is replaced. The short-term outcomes to be assessed are the number of infant deaths before hospital discharge and infant breathing difficulties, defined as needing oxygen at 28 days after delivery. We test the surviving infants’ lung function and development up to two years of age.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Liverpool Women's Hospital (UK)
When is the study starting and how long is it expected to run for?
October 2007 to October 2014
Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK)
Who is the main contact?
Dr Devender Roberts
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 07/39/01; N0128129813
Study information
Scientific title
Amnio infusion in preterm premature rupture of membranes (AMIPROM study)
Acronym
AMIPROM
Study hypothesis
The aim of this project is to study whether intervention for premature rupture of membranes (PROM) improves the outcome for babies. The study will compare the neonatal, maternal and pregnancy outcomes in pregnancies with very early PROM managed expectantly or managed with serial amnioinfusions.
More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/073901
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0006/51828/PRO-07-39-01.pdf
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Pregnancy and Childbirth: Preterm premature rupture of membranes
Intervention
Randomised controlled trial. Women with very early premature rupture of membranes will be randomised into (a) expectant management or (b) serial amnioinfusions.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
The study will compare the neonatal, maternal and pregnancy outcomes in pregnancies with very early PROM managed expectantly with those managed with serial amnioinfusions (replacement of fluid into the amniotic sac).
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/10/2007
Overall trial end date
31/10/2014
Reason abandoned
Eligibility
Participant inclusion criteria
15 women with premature rupture of membranes in each arm
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
15
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/2007
Recruitment end date
31/10/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Liverpool Women's Hospital
Liverpool
L8 7SS
United Kingdom
Sponsor information
Organisation
Liverpool Women's NHS foundation Trust (UK)
Sponsor details
Crown Street
Liverpool
L8 7SS
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 pilot results in http://fn.bmj.com/content/98/Suppl_1/A3.3.full.pdf+html
2013 results in http://www.ncbi.nlm.nih.gov/pubmed/24265189
2014 results in http://www.ncbi.nlm.nih.gov/pubmed/24713309
Publication citations
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Results
Roberts D, Vause S, Martin W, Green P, Walkinshaw S, Bricker L, Beardsmore C, Shaw N, McKay A, Skotny G, Williamson P, Alfirevic Z, Amnioinfusion in very early preterm prelabor rupture of membranes (AMIPROM): pregnancy, neonatal and maternal outcomes in a randomized controlled pilot study., Ultrasound Obstet Gynecol, 2014, 43, 5, 490-499, doi: 10.1002/uog.13258.
-
Results
Roberts D, Vause S, Martin W, Green P, Walkinshaw S, Bricker L, Beardsmore C, Shaw BN, McKay A, Skotny G, Williamson P, Alfirevic Z, Amnioinfusion in preterm premature rupture of membranes (AMIPROM): a randomised controlled trial of amnioinfusion versus expectant management in very early preterm premature rupture of membranes--a pilot study., Health Technol Assess, 2014, 18, 21, 1-135, doi: 10.3310/hta18210.