HOLDS

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HOLDS is a multicentre, double-blind randomised controlled trial to evaluate whether a high dose regimen oxytocin for nulliparous women delayed in the first stage of labour reduces the caesarean section (CS) rate. These women have a relatively high rate of unplanned CS (34%) and making sure the rate is as low as possible is important as unplanned CS is associated with longer stay in hospital, higher risk of infection, bleeding and blood clots and is associated with an increased risk of CS in subsequent pregnancies.

Robust evidence as to how best to care for women with delayed labour is lacking and it is a research priority for the Royal College of Obstetricians and Gynaecologists (RCOG). The length of labour for nulliparous women is on average 8 hours and it is unlikely to last over 18 hours. In line with NICE guidance once a woman is in established labour (i.e. she has regular painful contractions and her cervix is 4cms or more dilated on examination) assessment of progress includes: cervical dilation as well as descent and rotation of the baby's head and changes in the strength, duration and frequency of uterine contractions. Should delay be suspected (when cervical dilation of <2cm in four hours) the woman remains under the care of a midwife, providing all other parameters remain normal. During the two hour period until progress is re-assessed the midwife is likely to suggest interventions which would facilitate progress occurring. The midwife caring for the woman would encourage the woman to mobilise, consider hydration (e.g. a sports drink), and discuss appropriate and effective pain relief. If her membranes are still intact, artificial rupture (amniotomy) will also be advised. Once delay is confirmed if cervical progress < 1cm found on re-assessment, transfer to obstetric-led care would take place (if required) for an obstetric review and a decision about management options. The only recommended treatment is Syntocinon® which is an inexpensive licensed synthetic version of the hormone oxytocin. It is routinely given by intravenous infusion to stimulate contractions leading to birth.

Who is eligible for the HOLDS Trial?

Inclusion criteria

Nulliparous women with singleton cephalic pregnancy at term
(37 weeks + 0 days - 41 weeks + 6 days gestation)

Confirmed delay in labour and ruptured membranes for whom the clinical decision has been made to prescribe Syntocinon for augmentation of labour

According to NICE guidance [NICE 2014], labour is established when there are regular painful contractions and progressive cervical dilation from 4 cm. Delay is suspected when cervical dilation of

< 2 cm in 4 hours occurs once labour is established. Delay is confirmed when progress of <1 cm in 2 hours is found on repeat vaginal examination.

Exclusion criteria

Multiparous women

Nulliparous women who:

̶ have reached full dilation of the cervix (10cms)

̶ are undergoing induction of labour

̶ have a BMI >40 at booking

̶ have a multiple pregnancy

̶ have existing cardiac disease, bleeding disorders, diabetes (either pre-existing or gestational), previous uterine surgery

̶ have had significant antepartum haemorrhage

̶ are under 16 years of age

̶ have a known contra-indication to oxytocin therapy as listed in the Summary of marketing Product Characteristics (SPC)