Condition category
Pregnancy and Childbirth
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
19/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Devender Roberts

ORCID ID

Contact details

Fetal Centre
Liverpool Women's Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom

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

http://www.lwh.me.uk/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes

19/04/2016: Plain English summary added. On 11/05/2009 the funder was changed from Liverpool Women's Hospital NHS Trust (UK) to NIHR Health Technology Assessment Programme - HTA (UK). On 03/06/2008 the overall trial start and end dates were updated. The previous dates were as follows: Previous overall trial start date: 18/07/2002 Previous overall trial end date: 18/07/2009