Amnio infusion in preterm premature rupture of membranes
| ISRCTN | ISRCTN81932589 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81932589 |
| Protocol serial number | HTA 07/39/01; N0128129813 |
| Sponsor | Liverpool Women's NHS foundation Trust (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
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). |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/10/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
L8 7SS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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
