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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1185-3426 | Other Identifier | (Universal Trial Number)The World Health Organisation |
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| Name | Class |
|---|---|
| Lancashire Care NHS Foundation Trust | NETWORK |
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This is a pilot study that will eventually result in a main randomised controlled trial that will look at what management is associated with a higher rate of normal birth and a lower rate of chorioamnionitis (maternal infection) when women break their waters but labour does not start. Spontaneous rupture of the membranes (when the waters break) at term (37-42 weeks gestation) is a physiological event that happens during labour. However, according to Gunn et al. (1970) in 8-10 % of the cases the membranes rupture before labour starts. The time between the rupture and the onset of labour is called latent phase and time wise is variable.
Studies have showed no statistically significant differences in terms of neonatal infection or chorioamnionitis when the investigators induce labour with prostaglandins compared to when labour starts spontaneously (Hannah et al 1996). Seaward et al. (1997) noted a number of confounding factors that might relate to the incidence of chorioamnionitis (maternal infection), the strongest predictor was having more than 8 vaginal examinations since the rupture of membranes and before delivery which was a stronger predictor than the duration of the latent phase. It is thought that by reducing the number of internal examinations, chorioamnionitis may be reduced, and hence neonatal infection may also be reduced. The main RCT will compare clinical outcomes and maternal satisfaction when women consent to be randomized to four groups: (1) Active management and routine internal examinations during labour, (2) Active management and reduced internal examinations, (3) Expectant management and routine internal examinations, (4) Expectant management and reduced internal examinations.
This application seeks ethics approval for the pilot phase to ensure that a definitive study can be undertaken appropriately. It is important to test that all the components work well individually and as a whole, to estimate sample size and ultimately to test the integrity of the research protocol before embarking on the main trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Expectant management and minimal vaginal examinations | Experimental | Expectant management up to approximately 96hours and vaginal examinations only when necessary during active labour |
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| Expectant management and routine vaginal examinations | Experimental | Expectant management up to approximately 96hours and routine vaginal examinations during active labour |
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| Active management and minimal vaginal examinations | Experimental | Induction of labour at approximately 24hours and vaginal examinations only when necessary during active labour |
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| Active management and routine vaginal examinations | Active Comparator | Induction of labour at approximately 24hours and routine vaginal examinations |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Expectant management | Procedure |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of eligible women who agree to take part in the study | 12 months during pilot stage |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who stay in the allocation arm | 12 months during pilot stage | |
| Percentage of participants who find the interventions acceptable | Acceptability of the interventions to participants as measured by the study questionnaire |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lucia Ramirez-Montesinos, MSc BSc | Contact | 00447897236172 | Lramirez-montesinos@uclan.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Lucia Ramirez-Montesinos, MSc BSc | University of Central Lancashire | Principal Investigator |
| Soo Downe, PhD MSc BSc | University of Central Lancashire | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lancashire Teaching Hospitals NHS Trust | Recruiting | Preston | Lancashire | United Kingdom |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| Minimal Vaginal examinations (only when necessary) |
| Procedure |
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| Active management | Procedure |
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| Routine vaginal examinations | Procedure |
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| The questionnaire will be completed by the participants between 4-8 weeks after giving birth |