ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618000086268

Ethics application status

Approved

Date submitted

13/12/2017

Date registered

19/01/2018

Date last updated

21/09/2021

Date data sharing statement initially provided

11/03/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Effect of electronic fetal monitoring method used during labour on emergency caesarean section rates: START (STan Australian Randomised Trial).

Scientific title

Comparing the effect of STan (cardiotocographic electronic fetal monitoring (CTG) plus analysis of the ST segment of the fetal electrocardiogram) with CTG alone on emergency caesarean section rates in labouring women with a cephalic, singleton fetus of at least 36 completed weeks gestation: an Australian randomised controlled trial.

Secondary ID [1]

NHMRC project grant 1129648

Universal Trial Number (UTN)

U1111-1206-6033

Trial acronym

START
(STan Australian Randomised Trial)

Linked study record

Health condition

Health condition(s) or problem(s) studied:

intrapartum fetal monitoring

childbirth

caesarean section

Condition category

Condition code

Reproductive Health and Childbirth

Childbirth and postnatal care

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This is a 3- year randomised controlled trial (with stratification for parity) comparing STan monitoring (intrapartum electronic fetal monitoring using cardiotocography plus fetal monitoring of the ST segment of the electrocardiogram) with CTG monitoring (intrapartum cardiotocography) alone. The study will be implemented at the Women’s and Children’s Hospital (WCH), Adelaide (a Level 6 high risk specialist facility with approximately 5000 deliveries per annum). When there is clinical indication for electronic monitoring during labour for a woman who has given prior consent, randomisation to ‘STan monitoring’ or ‘CTG alone’ arms will take place with an allocation ratio of 1:1 using a web-based randomisation procedure. The electronic monitoring being assessed will take place from randomisation to the birth of the baby. The monitoring will be conducted by midwives and obstetricians who have been trained in the use of CTG and STan monitoring (holding Australian national FSEP CTG accreditation, as well as institutional in house accreditation for competency at STan interpretation). The staff will all be accredited to provide intrapartum care at the WCH (a level 6 tertiary maternity care institution). Within 2 weeks of birth, all cases and controls will be reviewed by a multidisciplinary panel of experienced clinicians to assess adherence to electronic fetal monitoring (CTG and STan) protocols and procedures. Any evidence of protocol violations will be fed back to the relevant providers to optimise protocol adherence.

Protocol for STan monitoring: A STan capable monitor will be connected to a tocodynometer on a belt applied to the woman’s waist. If her membranes are ruptured, a fetal scalp electrode (scalp clip) will be applied to the occipital region of the fetal scalp, and monitoring will commence as per guidelines. If membranes are still intact, they will be artificially ruptured when it is safe and clinically appropriate, a scalp clip will be applied to the fetus, and STan monitoring commenced. If it is not possible or clinically appropriate to rupture the membranes, an external belt mounted tocodynometer and CTG doppler will be commenced (as per clinical necessity, using RANZCOG guidelines). Once clinically appropriate and safe, the membranes will be ruptured, a fetal scalp clip will be applied and STan monitoring will commence.

Protocol for CTG (control) monitoring: A CTG machine in the delivery room will be activated. A belt with a tocodynometer will be applied to the woman’s waist. External monitoring of the fetal heart rate will commence by a belt mounted Doppler monitor around her waist, or if clinically indicated, a fetal scalp clip will be applied and monitoring will commence as per the RANZCOG guidelines.

A psychosocial questionnaire will be sent to all randomised women approximately 7-weeks after delivery. A subset of women who respond to the psychosocial questionnaire will be asked to complete a discrete choice experiment and semi structured interview.
Psychosocial questionnaire - EQ5D; general health questionnaire; Edinburgh Postnatal Depression Survey;Infant Feeding; Birth Satisfaction Survey; Monitoring response (purpose designed); trade off questions and open ended questions on positive and negative experiences.

Semi structured interviews: The interviews will seek to further understand women's experiences and satisfaction with the fetal monitoring they received. When women receive the psychosocial questionnaire, they will be asked to indicated if they are interested in participating in a qualitative review. 20- to 40 women will be ended to reach saturation. Interviews will take place at a time and location to suit the women.

Discrete choice experiment: Data from qualitative studies regarding STan will be used to determine the key factors or attributes related to preference. Interview data will inform the development of a subsequent preliminary survey applied to 20 women attending antenatal clinics. This will provide data to inform parameter values for the most efficient experimental design of the survey. The final Discrete Choice Experiment will be sent to all randomised women approximately 16-weeks after delivery. Sample size will depend upon the preliminary survey results, but previous work has indicated that approximately 100 in each arm should allow robust parameter estimation.

Intervention code [1]

Diagnosis / Prognosis

Intervention code [2]

Early detection / Screening

Intervention code [3]

Treatment: Devices

Comparator / control treatment

Those women fulfilling the study subject eligibility requirements and study admission criteria who have been randomised to the control arm will be the comparator group. They will have "routine care" with cardiotocographic monitoring, and will be managed by RANZCOG Intrapartum Fetal Surveillance Clinical Guidelines. 2006 (ISBN 0-947340). As per the experimental group, within 2 weeks of birth, all cases and controls will be reviewed by a multidisciplinary panel of experienced clinicians to assess adherence to electronic fetal monitoring protocols and procedures. Any evidence of protocol violations will be fed back to the relevant providers to optimise protocol adherence. The use of a scalp clip or external transducer in the control group will depend on clinical indication (mainly because of unsatisfactory signal from an external monitor), whereby all women randomised to STan monitoring will have a scalp clip applied to the fetus (because of the need to record the baby's ECG). Other than this and the use of STan monitoring, the management of control and experimental group will be identical

Control group

Active

Outcomes

Primary outcome [1]

Emergency caesarean section rate.

This will be assessed by a review of maternal medical records for mode of delivery.

Timepoint [1]

The outcome will be obtained from observation and recording in medical records by the midwife at the time of delivery.

Secondary outcome [1]

Intrapartum fetal death: comparison of outcome of babies born to mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) with those babies whose mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This outcome will be determined through a review of maternal medical records.

Timepoint [1]

The outcome of intrapartum fetal death will be assessed from time of randomisation until time of delivery from information documented in the maternal medical records.

Secondary outcome [2]

Neonatal death: comparison of outcome of babies born to mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) with those babies whose mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This outcome will be determined through a review of neonatal medical records.

Timepoint [2]

The outcome of neonatal death will be assessed from time of randomisation until 6 weeks after delivery date from information documented in the neonatal medical records.

Secondary outcome [3]

Neonatal outcome - Intubation for ventilation at delivery: comparison of outcome of babies born to mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) with those babies whose mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This outcome will be determined through a review of neonatal medical records.

Timepoint [3]

The neonatal outcome of intubation for ventilation will be assessed at the time of delivery from information documented in the neonatal medical records.

Secondary outcome [4]

Neonatal outcome - External cardiac massage at delivery: comparison of outcome of babies born to mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) with those babies whose mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This outcome will be determined through a review of neonatal medical records.

Timepoint [4]

The neonatal outcome of external cardiac massage will be assessed at the time of delivery from information documented in the neonatal medical records.

Secondary outcome [5]

Neonatal outcome - Arterial and venous cord blood gases (pH, lactate, base excess) at delivery: comparison of outcome of babies born to mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) with those babies whose mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This outcome will be determined through a review of neonatal medical records.

Timepoint [5]

The neonatal outcome of arterial and venous cord blood gases (pH, lactate, base excess) will be assessed at the time of delivery from information documented in the neonatal medical records.

Secondary outcome [6]

Neonatal outcome - APGAR scores at 1, 5 and 10 minutes at delivery: comparison of outcome of babies born to mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) with those babies whose mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This outcome will be determined through a review of neonatal medical records.

Timepoint [6]

The neonatal outcome of APGAR scores at 1, 5 and 10 minutes will be assessed at the time of delivery from information documented in the neonatal medical records.

Secondary outcome [7]

Neonatal outcome - seizures: comparison of outcome of babies born to mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) with those babies whose mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This outcome will be determined through a review of maternal and neonatal medical records.

Timepoint [7]

The neonatal outcome of neonatal seizures will be assessed from time of randomisation until 6 weeks after delivery date from information documented in the neonatal medical records.

Secondary outcome [8]

Neonatal outcome - Requirement for BRAINZ monitoring (yes/no and if yes, presence of abnormalities (yes/no)): comparison of outcome of babies born to mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) with those babies whose mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This outcome will be determined through a review of neonatal medical records.

Timepoint [8]

The neonatal outcome of requirement for BRAINZ monitoring will be assessed from time of delivery until 6 weeks after delivery date from information documented in the neonatal medical records.

Secondary outcome [9]

Neonatal outcome - Presence (yes/no) and, if present, grade (1, 2 or 3) of neonatal encephalopathy: comparison of outcome of babies born to mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) with those babies whose mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This outcome will be determined through a review of neonatal medical records.

Timepoint [9]

The neonatal outcome of neonatal encephalopathy will be assessed from time of delivery until 6 weeks after delivery date from information documented in the neonatal medical records.

Secondary outcome [10]

Neonatal outcome - Requirement for infant cooling (yes/no): comparison of outcome of babies born to mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) with those babies whose mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This outcome will be determined through a review of neonatal medical records.

Timepoint [10]

The neonatal outcome of requirement for infant cooling will be assessed from time of delivery until 6 weeks after delivery date from information documented in the neonatal medical records.

Secondary outcome [11]

Neonatal outcome - Proven infection (positive blood culture, cerebrospinal fluid culture or PCR): comparison of outcome of babies born to mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) with those babies whose mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This outcome will be determined through a review of neonatal medical records.

Timepoint [11]

The neonatal outcome of proven infection will be assessed from time of delivery until 6 weeks after delivery date from information documented in the neonatal medical records.

Secondary outcome [12]

Neonatal outcome - Antibiotic usage (yes/no) in the neonate: comparison of outcome of babies born to mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) with those babies whose mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This outcome will be determined through a review of neonatal medical records.

Timepoint [12]

The neonatal outcome of antibiotic usage will be assessed from time of delivery until 6 weeks after delivery date from information documented in the neonatal medical records.

Secondary outcome [13]

Neonatal outcome - Complications from use of scalp clip: comparison of outcome of babies born to mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) with those babies whose mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This outcome will be determined through a review of neonatal medical records.

Timepoint [13]

The neonatal outcome of complications from use of scalp clip will be assessed from time of delivery until 6 weeks after delivery date from information documented in the neonatal medical records.

Secondary outcome [14]

Neonatal outcome - Scalp trauma: comparison of outcome of babies born to mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) with those babies whose mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This outcome will be determined through a review of neonatal medical records.

Timepoint [14]

The neonatal outcome of scalp trauma will be assessed from time of delivery until 6 weeks after delivery date from information documented in the neonatal medical records.

Secondary outcome [15]

Neonatal outcome - Admission to special care nursery or neonatal intensive care (reason and duration): comparison of outcome of babies born to mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) with those babies whose mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This outcome will be determined through a review of neonatal medical records.

Timepoint [15]

The neonatal outcome of admission to special care nursery or neonatal intensive care will be assessed from time of delivery until discharge from hospital from information documented in the neonatal medical records.

Secondary outcome [16]

Neonatal outcome - Neonatal overall length of stay: comparison of outcome of babies born to mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) with those babies whose mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This outcome will be determined through a review of neonatal medical records.

Timepoint [16]

The neonatal outcome of overall length of stay will be assessed from time of delivery until discharge from hospital from information documented in the neonatal medical records.

Secondary outcome [17]

Neonatal outcome - Jaundice requiring phototherapy: comparison of outcome of babies born to mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) with those babies whose mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This outcome will be determined through a review of neonatal medical records.

Timepoint [17]

The neonatal outcome of jaundice requiring phototherapy will be assessed from time of delivery until 6 weeks after delivery date from information documented in the neonatal medical records.

Secondary outcome [18]

Neonatal outcome - Respiratory distress (yes/no) and if yes, severity based on level of support: mild (oxygen therapy only), moderate (need for CPAP or similar); severe (endotracheal ventilation, excluding use in resuscitation): comparison of outcome of babies born to mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) with those babies whose mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This outcome will be determined through a review of neonatal medical records.

Timepoint [18]

The neonatal outcome of respiratory will be assessed from time of delivery until 6 weeks after delivery date from information documented in the neonatal medical records.

Secondary outcome [19]

Neonatal outcome - Meconium aspiration syndrome: comparison of outcome of babies born to mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) with those babies whose mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This outcome will be determined through a review of neonatal medical records.

Timepoint [19]

The neonatal outcome of meconium aspiration syndrome will be assessed from time of delivery until 6 weeks after delivery date from information documented in the neonatal medical records.

Secondary outcome [20]

Neonatal outcome - Limb or clavicular fracture: comparison of outcome of babies born to mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) with those babies whose mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This outcome will be determined through a review of neonatal medical records.

Timepoint [20]

The neonatal outcome of limb or clavicular will be assessed at time of delivery from information documented in the neonatal medical records.

Secondary outcome [21]

Neonatal outcome - Neonatal readmission: comparison of outcome of babies born to mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) with those babies whose mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This outcome will be determined through a review of neonatal medical records.

Timepoint [21]

The neonatal outcome of neonatal readmission, will be assessed from initial discharge until 6 weeks after delivery date from information documented in the neonatal medical records.

Secondary outcome [22]

Maternal outcome - mode of delivery (other than primary outcome of LSCS, yes/no) including spontaneous, forceps, vacuum, forceps rotation, vacuum rotation: comparison of outcomes other than mode of delivery of mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) compared with mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This outcome will be determined through a review of maternal medical records.

Timepoint [22]

The maternal outcome of mode of delivery will be assessed at time of delivery from information documented in the maternal medical records.

Secondary outcome [23]

Maternal outcome - if emergency caesarean occurred, declared reason for caesarean section and Robson classification: comparison of outcomes of mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) compared with mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This outcome will be determined through a review of maternal medical records.

Timepoint [23]

The maternal outcome of reason for emergency caesarean section will be assessed at time of delivery from information documented in the maternal medical records.

Secondary outcome [24]

Maternal outcome - trial of assisted vaginal delivery resulting in caesarean section (yes/no) : comparison of outcomes of mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) compared with mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This outcome will be determined through a review of maternal medical records.

Timepoint [24]

The maternal outcome of trial of assisted vaginal delivery which resulted in emergency caesarean section will be assessed at time of delivery from information documented in the maternal medical records.

Secondary outcome [25]

Maternal outcome - Number and type of STan events as defined by the STan clinical guidelines and clinician responses to the ST event AND/OR number and classification of CTG abnormalities according the standard RANZCOG FSEP guidelines of CTG and clinician response to abnormalities: comparison of outcomes of mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) compared with mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone. This outcome will be determined through a review of maternal medical records.

Timepoint [25]

The maternal outcome of number, classification and response to STan events or CTG abnormalities will be assessed from information documented in the maternal medical records during the intrapartum period.

Secondary outcome [26]

Maternal outcome - maternal death or maternal ICU admission: comparison of outcome of mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) with those babies whose mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone. This outcome will be determined through a review of maternal medical records.

Timepoint [26]

The maternal outcome of death or ICU admission be assessed the intrapartum period until 6 weeks after delivery date from information documented in the maternal medical records.

Secondary outcome [27]

Maternal outcome - Use of (yes/no) and if yes, result of in utero fetal scalp pH or lactate: comparison of outcomes of mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) compared with mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This outcome will be determined through a review of maternal medical records.

Timepoint [27]

The maternal outcome of use of in utero fetal scalp pH or lactate will be assessed from information documented in the maternal medical records during the intrapartum period.

Secondary outcome [28]

Maternal outcome - Use of pharmacological analgesia (nitrous oxide, fentanyl, other opioids, perineal infiltration, pudendal block, epidural, spinal, other): comparison of outcomes of mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) compared with mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This outcome will be determined through a review of maternal medical records.

Timepoint [28]

The maternal outcome of use of pharmacological will be assessed from information documented in the maternal medical records during the intrapartum period.

Secondary outcome [29]

Maternal outcome - Use of non-pharmacological analgesia (TENS machine, lumbar water injection, bath/water immersion, shower, heat pack, massage, support person, hypnosis, other): comparison of outcomes of mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) compared with mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This outcome will be determined through a review of maternal medical records.

Timepoint [29]

The maternal outcome of use of non-pharmacological analgesia will be assessed from information documented in the maternal medical records during the intrapartum period.

Secondary outcome [30]

Maternal outcome - Complications of labour and delivery (composite outcome including: episiotomy, perineal tears, pyrexia, meconium stained liquor, chorioamnionitis, gestational hypertension, pre-eclampsia, eclampsia, shoulder dystocia, intrapartum bleeding, postpartum haemorrhage >600ml, manual removal of retained placenta, transfusion, caesarean section complications): comparison of outcomes of mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) compared with mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This outcome will be determined through a review of maternal medical records.

Timepoint [30]

The maternal composite outcome of complications of labour and delivery will be assessed from information documented during the intrapartum period and at delivery.

Secondary outcome [31]

Maternal outcome - Maternal overall length of stay: comparison of outcome of mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) with mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This outcome will be determined through a review of maternal medical records.

Timepoint [31]

The maternal outcome of overall length of stay will be assessed from entries documented in maternal medical records from admission to hospital until discharge from hospital.

Secondary outcome [32]

Maternal outcome - Maternal length of stay (randomisation until discharge): comparison of outcome of mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) with mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This outcome will be determined through a review of maternal medical records.

Timepoint [32]

The maternal outcome of length of stay (randomisation until discharge) will be assessed from entries documented in maternal medical records from time of randomisation into the study until discharge from hospital.

Secondary outcome [33]

Maternal outcome - Readmission: comparison of outcome of mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) with mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This outcome will be determined through a review of maternal medical records.

Timepoint [33]

The maternal outcome of readmission will be assessed from entries documented in maternal medical records from discharge from hospital until six-weeks post delivery.

Secondary outcome [34]

Maternal psychosocial outcomes (questionnaire) - satisfaction with intrapartum care: comparing mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) compared with mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This will be quantified using a questionnaire, which combines the EQ5D, General Health Questionnaire, Edinburgh Postnatal Depression Survey (EPDS), Infant Feeding; the birth satisfaction survey; monitoring satisfaction (purpose designed); trade off questions and open ended questions on positive and negative experiences.

Timepoint [34]

The psychosocial outcomes questionnaire described above will be sent to all randomised women approximately 7-weeks after delivery, with the exception of women with severe adverse outcomes (e.g. fetal death).

Secondary outcome [35]

Maternal psychosocial outcomes (questionnaire) - physical outomes: comparing mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) compared with mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This will be quantified using a questionnaire, which combines the EQ5D, General Health Questionnaire, Edinburgh Postnatal Depression Survey (EPDS), Infant Feeding; the birth satisfaction survey; monitoring satisfaction (purpose designed); trade off questions and open ended questions on positive and negative experiences.

Timepoint [35]

Secondary outcome [36]

Maternal psychosocial outcomes (questionnaire) - psychological outcomes: comparing mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) compared with mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This will be quantified using a questionnaire, which combines the EQ5D, General Health Questionnaire, Edinburgh Postnatal Depression Survey (EPDS), Infant Feeding; the birth satisfaction survey; monitoring satisfaction (purpose designed); trade off questions and open ended questions on positive and negative experiences.

Timepoint [36]

Secondary outcome [37]

Maternal psychosocial outcomes (questionnaire) - breastfeeding practices: comparing mothers who were randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) compared with mothers who were randomised to intrapartum electronic fetal monitoring using CTG alone.

This will be quantified using a questionnaire, which combines the EQ5D, General Health Questionnaire, Edinburgh Postnatal Depression Survey (EPDS), Infant Feeding; the birth satisfaction survey; monitoring satisfaction (purpose designed); trade off questions and open ended questions on positive and negative experiences.

Timepoint [37]

Secondary outcome [38]

Psychosocial outcome (semi-structured face to face interviews) of mothers who had intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) compared with mothers who had intrapartum electronic fetal monitoring using CTG alone: a qualitative study using semi-structured face to face interviews will be conducted to gain an in-depth understanding of women's experiences with labour care and fetal monitoring.

Timepoint [38]

A subset of women who return the psychosocial questionnaire who indicated that they were interested in participating, and who provide their details for follow-up will be contacted about consent for a face-to-face interview regarding their satisfaction and experience with the electronic fetal monitoring they received. It is anticipated that interviews would occur approximately 10 weeks after birth.

Secondary outcome [39]

Cost comparison between women randomised to intrapartum electronic fetal monitoring using STan (cardiotocography (CTG) plus analysis of the ST segment of the fetal electrocardiogram) compared with women randomised to intrapartum electronic fetal monitoring using CTG alone.

Data from clinical feeder systems will be calculated on a full absorption basis including labour and postnatal ward, medical and midwifery staff, pathology, pharmacy, operating theatre, medical and surgical supplies, good and services. Preparation of costing data will conform to National Hospital Cost Data Collection standards. Direct cost comparisons will use case-mix classifications (Australian Related Diagnosis Groups classification, version 8.0).

Timepoint [39]

Costs will be assessed from time of randomisation until 6 weeks after delivery date.

Secondary outcome [40]

Discrete choice experiment (DCE) to determine the various trade-offs that women are prepared to make in making informed decisions about electronic fetal monitoring method.

This will be quantified using a purposed designed questionnaire.

Timepoint [40]

The DCE questionnaire will be sent to all randomised women approximately 16-weeks after delivery, with the exception of women with severe adverse outcomes (e.g. fetal death).

Eligibility

Key inclusion criteria

Demographic: greater than or equal to 18 years of age ; capable of informed consent; literate in English; singleton fetus; cephalic presentation.

Minimum age

18 Years

Maximum age

55 Years

Sex

Females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Exclusion criteria: Less than 36weeks gestation; planned caesarean; placenta praevia or vasa praevia; fetal structural or functional cardiac abnormalities; any contraindication to scalp clip usage; does not have a clinical indication for continuous electronic fetal monitoring; women who have participated in this trial in a previous pregnancy.

Psychosocial questionnaire, interview and discrete choice experiment: Women who had severe adverse clinical outcomes - maternal, fetal or neonatal death.

Study design

Purpose of the study

Diagnosis

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

The randomisation will be implemented by a telephone based system provided by the NH&MRC clinical trials centre at the University of Sydney.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The randomisation will be in stratified by parity (primiparous / multiparous) in a pre-determined schedule in order to facilitate data management of the study by the Data, Design, Statistics and Research IT Service of Adelaide Health Technology Assessment (AHTA), School of Public Health, The University of Adelaide. There will be adjustment for strata (defined by parity) used in the randomisation.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Sample size; Based upon our pilot study, it is appropriate to power the primary hypothesis on a reduction of emergency caesarean section from 17% to 12%, (i.e. a 5% difference); 80% power, and a two sided alpha 0.05. To detect an absolute difference of 5% between the 2 treatment groups would require a total sample size of 1,634 women. Allowing for a very conservative 10% dropout after consent, and a further 22% attrition due to no clinical indication for fetal monitoring in labour, and a possible further 5% non-compliance rate in the STan EFM arm after randomisation, means that consent would need to be gained from at least 2,588 women, 1,818 of whom will be subsequently randomised. This sample size would also provide ample power to detect clinically meaningful differences in secondary outcomes of interest.
Statistical analysis will follow standard methods for randomised trials and will be performed on an intention to treat basis, according to treatment allocation at randomisation. For dichotomous outcomes including the primary outcome of caesarean section (yes/no), proportions will be compared between treatment groups using the odds ratio with 95% CI, obtained from a logistic regression analysis with adjustment for strata (defined by parity) used in the randomisation. Further logistic regression analyses (for sensitivity) will examine the effect of adjustment for parity, as well as pre-specified prognostic baseline variables and/or variables not balanced (by chance) at baseline, with results reported as odds ratios with corresponding 95% CIs. Categorical outcomes will be compared using relevant generalised linear models, with results reported as differences in proportions (with 95% CIs). Continuous outcomes will be compared using differences between mean values estimated from normal linear regression adjusted for parity (with 95% CIs). Secondary analyses will explore evidence of heterogeneity of effects between the two parity strata using interaction tests and subgroup analyses. All subgroup comparisons will be pre-specified and performed with appropriate tests of interaction. All analyses will follow a pre-specified Statistical Analysis plan. Although this study will be underpowered to determine equivalence of neonatal outcomes or maternal secondary outcomes, the neonatal data will be able to be incorporated into meta-analyses including neonatal data from previous clinical trials (including the use of individual patient data). For the Discrete Choice Experiment, mixed models will be used to allow for random effects. Sociodemographic characteristics and interactions between attributes and such characteristics will be considered before final choice of the most efficient model. Models will be evaluated for goodness of fit using the likelihood ratio Chi-square statistic for the global test of zero model coefficients, the McFadden’s pseudo R-squared, and the Akaike’s information criterion (AIC). Results will be presented as beta parameters, odds ratios with 95% confidence intervals.
Cost effectiveness data: Data collected from clinical feeder systems will be calculated on a full absorption basis including labour and postnatal ward, medical and midwifery staff, pathology, pharmacy, operating theatre, medical and surgical supplies, good and services. Preparation of costing data will conform to National Hospital Cost Data Collection standards. Direct cost comparisons will use case-mix classifications (Australian Related Diagnosis Groups classification, version 8.0) Bootstrapping will estimate a distribution around costs and health outcomes (primarily emergency caesarean section), and confidence intervals around the incremental cost-effectiveness ratio will be determined. One-way sensitivity analysis will be conducted around key variables, and a probabilistic sensitivity analysis will be conducted to estimate joint uncertainty in all parameters.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

22/01/2018

Actual

22/01/2018

Date of last participant enrolment

Anticipated

30/09/2021

Actual

Date of last data collection

Anticipated

15/10/2021

Actual

Sample size

Target

1818

Accrual to date

882

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Womens and Childrens Hospital - North Adelaide

Recruitment postcode(s) [1]

5006 - North Adelaide

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

GHD Building Level 1, 16 Marcus Clarke St, Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Individual

Name

Assoc Professor Chris Wilkinson

Address

Women's and Children's Hospital
72 King William Rd
North Adelaide 5006
South Australia

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Professor Deborah Turnbull

Address [1]

721 Level 7 Hughes
The University of Adelaide
Adelaide, 5006
South Australia

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Professor Ben Mol

Address [2]

Women's and Children's Hospital
72 King William Rd
North Adelaide
South Australia 5006

Country [2]

Australia

Secondary sponsor category [3]

Individual

Name [3]

Dr Andrew McPhee

Address [3]

Women's and Children's Hospital
72 King William Rd
North Adelaide
South Australia 5006

Country [3]

Australia

Secondary sponsor category [4]

Individual

Name [4]

Dr Amy Salter

Address [4]

The University of Adelaide
Room WS9062.48
Adelaide Health and Medical Sciences Building
North Terrace
Adelaide 5000
South Australia

Country [4]

Australia

Secondary sponsor category [5]

Individual

Name [5]

Professor Ian Symonds

Address [5]

The University of Adelaide
3 060
Adelaide Health and Medical Sciences Building
North Terrace
Adelaide
South Australia 5000

Country [5]

Australia

Secondary sponsor category [6]

Individual

Name [6]

Dr Edwin Chandraharan

Address [6]

St George's Hospital
Blackshaw Road
Tooting
London SW17 0QT

Country [6]

United Kingdom

Other collaborator category [1]

Individual

Name [1]

Dr Sabrina Kuah

Address [1]

Women's and Children's Hospital
72 King William Rd
North Adelaide
South Australia 5006

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Dr Geoff Matthews

Address [2]

Women's and Children's Hospital
72 King William Rd
North Adelaide
South Australia 5006

Country [2]

Australia

Other collaborator category [3]

Individual

Name [3]

Professor Kirsten Howard

Address [3]

Department of Public Health
The University of Sydney
Camperdown 2006
New South Wales

Country [3]

Australia

Other collaborator category [4]

Individual

Name [4]

Judy Coffey

Address [4]

Women's and Childrens Hospital
72 King William Rd
North Adelaide
South Australia 5006

Country [4]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Women's and Children's Health Network (WCHN) Human Research Ethics Committee's (HREC)

Ethics committee address [1]

Level 2
Samuel Way building
72 King William Rd
North Adelaide
South Australia
5006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

06/12/2017

Approval date [1]

20/12/2017

Ethics approval number [1]

HREC/17/WCHN/14

Summary

Brief summary

Women in high risk labour have their babies monitored by electronic fetal monitoring. This detects unborn babies not coping during labour, but may lead to unnecessary caesarean sections by incorrectly indicating that the baby is at risk. We will compare CTG to STan monitoring, which may give fewer false readings. We will show if STan reduces emergency caesarean section, and will investigate the impact on the baby, assess psychological aspects such as mental health and wellbeing, and costs.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Chris Wilkinson

Address

Perinatal Medicine
QVB Women's and Children's Hospital
72 King William Rd
North Adelaide SA 5006

Country

Australia

Phone

+61 8 81617633

Fax

+61 8 81627654

[email protected]

Contact person for public queries

Name

Dr Bronni Simpson

Address

Perinatal Medicine
QVB Women's and Children's Hospital
72 King William Rd
North Adelaide SA 5006

Country

Australia

Phone

+61 8 81617000

Fax

+61 8 81627654

[email protected]

Contact person for scientific queries

Name

A/Prof Chris Wilkinson

Address

Perinatal Medicine
QVB Women's and Children's Hospital
72 King William Rd
North Adelaide SA 5006

Country

Australia

Phone

+61 8 81617633

Fax

+61 8 81627654

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

In the first instance, the research team will be analysing all trial data, however, IPD may become available once analysis is complete and published.

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically