Labor Complication Clinical Trial
Official title:
Prostaglandin Insert (Propess) Versus Trans-cervical Balloon Catheter for Out-patient Labour Induction: A Randomised Controlled Trial of Feasibility
This study will randomise low-risk women to compare the effectiveness of trans-cervical balloon catheter for pre-induction cervical ripening for out-patient induction of labour with current practice (Propess). Women will be randomised to two treatment groups. The investigators wish to explore if such a trial is feasible, acceptable to women and what data collection is required for a future trial. Since no data exist, the investigators propose a study with approximately 60 women in each arm across two recruiting sites.
The study will be conducted over two sites: St. George's Hospital in London, and Medway
Hospital in Kent. Women requiring induction of labour (IOL) at term will be invited to
participate in the study, where they will be randomised to either the trans-cervical balloon
catheter or the vaginal prostaglandin 10mg (Propess).
Consent to enter this study will be obtained after 37+0 weeks after a full account has been
provided of its nature, purpose, risks, burdens and potential benefits. Patients will have
the opportunity to consider whether they wish to take part in the study, up to a maximum of
72 hours. For prolonged pregnancy (41+0 weeks), Induction of labour is generally booked at
41+3 weeks, giving a 3-day time period to think about participation. Periods shorter than 72
hours will be permitted if the woman felt that further deliberation will not lead to a change
in her decision, and provided the person seeking consent is satisfied that the woman has
fully retained, understood and deliberated on the information given. This provision has been
made with the support of our patient advisory group. Likewise, periods longer than 72 hours
will be permitted should the woman request this. The Investigator or designee will explain
that the women are under no obligation to enter the trial and that they can withdraw at any
time during the trial, without having to give a reason. A copy of the signed Informed Consent
Form will be given to the study participant. The original signed consent form (ICF) will be
retained at the study site in the Investigation site file (ISF) and a copy of the ICF along
with a copy of the Participant Information Sheet (PIS) will be retained in the maternity
notes.
If new safety information results in significant changes to the risk-benefit assessment, the
consent form will be reviewed and updated if necessary. All subjects, including those already
treated, will be informed of the new information, given a copy of the revised consent form
and asked to re-consent if they choose to continue in the study.
In order to ensure a similar distribution between treatment groups in important
characteristics thought to affect outcomes, including site and parity, allocation will be
random and stratified by site (St. George's and Medway) and parity (nulliparous and
multiparous). Participants will be allocated using block randomisation so as to ensure
similar numbers of participants in the treatment groups. Whilst blocks of size four are
proposed, advice regarding random block sizes (including four, six and eight) will be sought
from the Kings Clinical Trials Unit (CTU).
Participants and midwives will not be blinded to the treatment allocation. The trial
statistician will be blinded to group allocation.
The trial will be analysed using an intention to treat approach. Induction of labour with
Propess: 10mg insert will be introduced in the posterior vaginal fornix close to the cervix
as recommended by the manufacturer. Women will undergo monitoring of fetal condition and
uterine activity by cardio-tocography (CTG) according to the existing protocol. It will be
discontinued once the CTG is deemed to be normal. The woman will be allowed home with
instructions to return to the hospital at an agreed time, 18-24 hours later, or if in labour,
whichever was earlier. On the following morning the pessary will be removed, and artificial
rupture of membranes (ARM) attempted.
Induction of labour with balloon catheter: The woman should be positioned in the lithotomy
position and insert a large vaginal speculum to gain cervical access. The cervix must be
cleaned appropriately to prepare for device insertion. Insert the device into the cervix and
advance until both balloons have entered the cervical canal. Inflate the uterine balloon with
40ml Sodium Chloride (NaCL) 0.9% using a standard luer lock 20ml syringe through the red
check-flo valve marked U.
Once the uterine balloon is inflated, the device is pulled back until the balloon is against
the internal cervical os. The vaginal balloon is now visible outside the external cervical
os. Inflate the vaginal balloon with 20ml NaCl 0.9% using a standard luer lock 20ml syringe
through the green Check-Flo valve marked V. Once the balloons are situated on each side of
the cervix and the device is fixed in place, remove the speculum. Add more fluid to each
balloon in turn, in 20ml increments until each balloon contains 80ml (maximum volume of
fluid) Do NOT overinflate the balloons. If desired the end of the catheter may be taped to
the woman's thigh.
Women will undergo monitoring of fetal condition and uterine activity by cardio-tocography
(CTG) according to the existing protocol. It will be discontinued when the CTG is deemed to
be normal. The woman will be allowed home with instructions to return to the hospital an
agreed time, 18-24 hours later, or if in labour, whichever was earlier. When the participant
returns, the balloon catheter will be removed, and artificial rupture of membranes (ARM)
attempted.
If artificial rupture of membranes was not possible, this will be considered as treatment
failure and alternative ways of achieving delivery will be sought as per local guidelines and
followed. Unsuccessful placement of the balloon or inability to perform ARM will be
considered as treatment failure and an alternative method of IOL will be used.
Survey
1. Recruitment Survey. Questionnaires will be given to all women at the point of
recruitment. Women who decline will be invited to complete the questionnaire anonymously
and it will be made clear that the aim of the survey is solely to improve future care
through assessing the feasibility of the balloon catheter with no implications for their
own care. The schedule will comprise closed questions plus comment boxes to examine
women's understanding of the trial, their reasons for participation or declining. A
detailed process log will also be maintained to identify the numbers and proportions of
women who accept randomisation and those who withdraw after entry to the trial.
2. Follow-up questionnaire for participants: We will use a slightly modified form of
questionnaire used previously used by Henry et al (2013) to assess patient satisfaction,
experience of participating, experience of the IoL process using either method including
pain or discomfort, experience of outpatient IoL and level of information provided.
Qualitative study In addition, qualitative data will be gathered for a sample of participants
to enable a fuller exploration of the trial feasibility in two stages.
1. To gain a better understanding of feasibility and effective trial procedures for a trial
where interventions cannot be blinded and preferences may be strong. A researcher with
experience of studies of trial processes, independent of the trial management, will
(with consent of women and professionals) observe a sample of recruitment discussions to
ascertain how information is provided and to understand in greater depth how choices
about trial participation are made. The focus will include diversity issues, as
typically participation in randomized controlled trials (RCTs) is socially and
ethnically skewed. This will be a consecutive sample continued until saturation to
include women allocated randomly and those in the preference arms, those women who
decline and a cross-section of social and ethnic groups. Estimated sample: 40
recruitment observations.
2. Women included in observations who consented to participate in the trial will be invited
to participate in semi structured interviews postnatally, to explore their experience of
participating and of the IoL process using either method, their experience of outpatient
IOL and any further reflections. Those who provide telephone details will be contacted
postnatally to confirm whether they are still happy to participate in an interview,
following checks of neonatal outcomes. All women and professionals will be assured of
confidentiality and their rights to decline consent for observation or interview. A
thematic framework analysis will be conducted focused on lessons for trial feasibility,
design, recruitment and retention, and patient experiences of cervical ripening using
either method for induction in an outpatient setting. This approach enables
consideration of unintended as well as anticipated consequences plus a fuller
understanding of how women and their birth partners experience induction of labour and
whether an outpatient approach confers advantages in terms of experience and
satisfaction since, despite this being a key rationale for an outpatient approach,
patient experiences of different induction approaches is an under-explored area. The
number of interviews will be guided by data saturation, with a maximum potential sample
of 40.
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