Prelabour Rupture of Membranes at Term Clinical Trial
Official title:
"Active vs Expectant Management and Routine vs Only-when-necessary Vaginal Examinations During Labour for Prelabour Rupture of Membranes at Term, a Pilot RCT Study"
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.
| Status | Recruiting |
| Enrollment | 120 |
| Est. completion date | November 2017 |
| Est. primary completion date | October 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 45 Years |
| Eligibility |
Inclusion Criteria: - Prelabour rupture of membranes (confirmed) - Term pregnancy - from 37+0 till 41+2 weeks gestation (both inclusive) - Normal/Low risk pregnancy - Singleton, cephalic pregnancy - No known current infectious diseases - Aged 18-45 years old - Understands English and is able to read and write in English - Agree for their placentas to be sent to histology if clinical signs of infection - Not taking part in other clinical research at present - Consent to take part Exclusion criteria: - Pregnancy of 36+6 or less or 41+3 or more weeks gestation - Breech or oblique presentation - Twin or multiple pregnancy - Previous caesarean section - Meconium stained liquor - Pre-eclampsia - Diabetes - Known to be colonised by Group B streptococcus - Current infections: HIV, Hepatitis B, Herpes - Doesn't give consent for the placenta to be sent to histology if clinical signs of infection - Not able to understand, read or write in English - Currently taking part in other clinical research |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Lancashire Teaching Hospitals NHS Trust | Preston | Lancashire |
| Lead Sponsor | Collaborator |
|---|---|
| University of Central Lancashire | Lancashire Care NHS Foundation Trust |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of eligible women who agree to take part in the study | 12 months during pilot stage | No | |
| Secondary | Percentage of participants who stay in the allocation arm | 12 months during pilot stage | No | |
| Secondary | Percentage of participants who find the interventions acceptable | Acceptability of the interventions to participants as measured by the study questionnaire | The questionnaire will be completed by the participants between 4-8 weeks after giving birth | No |