Amnio infusion in preterm premature rupture of membranes
| ISRCTN | ISRCTN81932589 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81932589 |
| Secondary identifying numbers | HTA 07/39/01; N0128129813 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 19/04/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
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
Contact information
Scientific
Fetal Centre
Liverpool Women's Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Amnio infusion in preterm premature rupture of membranes (AMIPROM study) |
| Study acronym | AMIPROM |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/10/2007 |
| Completion date | 31/10/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 15 |
| Key inclusion criteria | 15 women with premature rupture of membranes in each arm |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/10/2007 |
| Date of final enrolment | 31/10/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
L8 7SS
United Kingdom
Sponsor information
Hospital/treatment centre
Crown Street
Liverpool
L8 7SS
England
United Kingdom
| Website | http://www.lwh.me.uk/ |
|---|---|
"ROR" |
https://ror.org/04q5r0746 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | pilot results | 01/04/2013 | Yes | No | |
| Results article | results | 01/04/2014 | Yes | No | |
| Results article | results | 01/05/2014 | Yes | No |
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
