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safety of partial outpatient induction of labour with a balloon catheter


- candidate number27837
- NTR NumberNTR6684
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-sep-2017
- Secondary IDsNW2017-20 METC Tilburg
- Public Titlesafety of partial outpatient induction of labour with a balloon catheter
- Scientific TitleSafety and cost-effectiveness of induction of labour with a Foley catheter in an outpatient setting
- ACRONYMPROBAAT-home
- hypothesispartial outpatient induction is safe in lowrisk pregnancies.
- Healt Condition(s) or Problem(s) studiedInduction of labour, Safety, Foley catheter
- Inclusion criteria Term pregnancy (≥37 weeks gestation)
Indication for induction of labour
Vital singleton pregnancy
Cephalic presentation
Planned for outdoor induction of labour
Unfavourable cervix (Bishop score <6)
Intact membranes
- Exclusion criteria Lethal congenital anomaly
Placenta praevia (marginalis) (placenta ≤2cm from ostium)
Non-reassuring fetal heart rate prior to induction
Indication for clinical surveillance (extreme FGR, pre eclampsia/HELLP, uncontrolled (gestational) diabetes mellitus)
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-aug-2017
- planned closingdate31-jul-2019
- Target number of participants1500
- Interventionspartial outpatient induction of labour with a foley catheter according to local protocol. observational study of routine care.
- Primary outcome- (Severe) adverse events during outpatient period
- Adverse neonatal outcome
- Causal relation between (severe) adverse event/neonatal outcome and outpatient period judged by an expert panel
- Secondary outcome- maternal and perinatal morbidity
- efficacy
- cost-effectiveness
- Timepointsall data will be collected from patient files after delivery:
PRIMARY OUTCOME PARAMETERS:
Severe adverse events during outpatient period
Umbilical cord prolaps
Excessive bleeding/suspected placental abruption
Uterine rupture/ uterine scar dehiscence
Fetal demise
Non-reassuring fetal heart rate (FHR) tracing at re-admission requiring a caesarean section
Eclampsia

Adverse events during outpatient period
Infection (defined as a temperature ≥ 38.0C)
Severe hypertension (> 160/110) or pre-eclampsia
Malpresentation at readmission
Non-reassuring fetal heart rate (FHR) tracing at re-admission
Early readmission for severe pain or anxiety

Adverse neonatal outcome
Apgar score <7 after 5 minutes or
pH in umbilical cord <7.00 or
neonatal admission to a NICU

Causal relation between (severe) adverse event/neonatal outcome and outpatient period judged by an expert panel
delay in acute medical care (yes/no)
Influence of delay on maternal and perinatal outcome (yes/no)
Other


SECONDARY OUTCOME PARAMETERS
Perinatal morbidity until discharge
o Apgar score < 7 at 1 and 5 minutes
o pH ≤ 7.10 and pH ≤ 7.05
o Admissions to the neonatal ward/NICU
o Meconium stained liquor and meconium aspiration syndrome (MAS)
o Neonatal respiratory distress syndrome (RDS)
o (Suspected) neonatal infection or sepsis
o Necrotising enterocolitis
o intraventricular haemorrhage
o Periventricular leucomalacia
o Convulsions

Perinatal death
o Maternal morbidity until discharge
o Postpartum haemorrhage (defines a an estimated blood loss >1000 cc)
o Maternal post partum blood transfusion
o Maternal infection
 Intra partum: (defined as a temperature ≥ 38.0C) during labour or fetal tachycardia with start of antibiotics
 Post partum: Endo(myo)metritis or urinary tract infection within one week post partum (proven positive vaginal discharge/urine culture)

Efficacy
o Induction to vaginal delivery time
o Total admission time
o Mode of delivery (spontaneous, vaginal instrumental or caesarean section)
o Indication for instrumental delivery (fetal distress and/or failure to progress)
o Early readmission
o Favourable cervix at readmission

costs of induction
o Resource use will be derived from the Case Report Form.
o Different methods and sources will be used to estimate unit costs as valuations for documented volumes of resource use. For maternal and neonatal admissions, third-stage delivery and neonatal monitoring, unit costs will be estimated with data from the financial departments of various academic and general hospitals. For use of the labour room and the operating theatre, unit costs are calculated per hour, using a bottom-up approach. For some cost units national standardised prices will be used, and for laboratory testing, published tariffs will be used.
o Data concerning cost-effectiveness will be compared to data collected in the PROBAAT 2 study for women induced with a Foleycatheter. Details about the PROBAAT 2 study are presented in appendix 3 of the original study protocol
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Marieke de Vaan
- CONTACT for SCIENTIFIC QUERIES Marieke de Vaan
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- Publications
- Brief summaryInduction of labour is common practice in pregnancies at risk. A safe and effective method for induction is insertion of a Foley catheter. A number of Dutch hospitals implemented the Foley catheter in a combined hospital and outpatient setting. Whether this policy is safe in terms of maternal and perinatal mortality and morbidity is uncertain as large studies are lacking. We will perform a multicentre observational study in which women planned for outpatient induction with a Foley catheter are followed. Primary outcomes will be perinatal and maternal adverse events. Secondary outcomes will be efficacy and cost-effectiveness.
- Main changes (audit trail)
- RECORD8-sep-2017 - 16-sep-2017


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