High Dose Versus Low Dose Oxytocin for Augmentation of Delayed Labour

Birth; Delayed Clinical Trial

— OxyHighLow  

Official title:

High Dose Versus Low Dose Oxytocin for Augmentation of Delayed Labour

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01587625
• Other study ID #: Oxytocin high low dose
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: October 8, 2016

Study information

• Verified date: March 2019
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In a randomized control trial conducted in six study centers/labour wards in Sweden, consenting nulliparous women in active phase of labour and with a defined delayed labour progress will be randomized to receive a regimen of either high or low dose of oxytocin. Primary outcome is caesarean delivery rate. Secondary outcomes are: Apgar score, need of neonatal intensive care, hyper-stimulation of contractions, spontaneous vaginal birth rate, length of labour, postpartum haemorrhage, sphincter lacerations, experienced labour pain, epidural analgesia and the women´s childbirth experience one month postpartum (assessed with Childbirth Experience Questionnaire). Study results will contribute to establish good evidence-based routines regarding oxytocin treatment of delayed labour progress.

Description:

The aim is to compare starting dose and increment of amount of oxytocin for augmentation of delayed labour to determine whether augmentation by high dose of oxytocin improves labour outcomes compared with a low dose of oxytocin, without effecting neonatal outcomes or birth experiences negatively.

Delay in labour, also described as poor progress, due to ineffective uterine contraction is a major problem in modern obstetric care and one of the main reasons for the increased rate of caesarean deliveries, in particular among nulliparous women. Infusion with synthetic oxytocin is a commonly used treatment of hypotonic uterine contractions. Despite the widespread use of oxytocin no consensus exists regarding the dosage of oxytocin, both starting dose and increment of amount of oxytocin.

In a randomized control trial conducted in six study centers/labour wards in Sweden, consenting nulliparous women in active phase of labour and with a defined delayed labour progress will be randomized to receive a regimen of either high or low dose of oxytocin. The expected outcome is a decreased caesarean section rate and increased rate of spontaneous vaginal delivery for women with high dose of oxytocin for augmentation, without affecting neonatal outcomes or childbirth experiences negatively.

Primary outcome is caesarean delivery rate. Secondary outcomes are Apgar score, need of neonatal intensive care, hyper-stimulation of contractions, spontaneous vaginal birth rate, length of labour, postpartum haemorrhage, sphincter lacerations, experienced labour pain, epidural analgesia and the women´s childbirth experience one month postpartum (assessed with Childbirth Experience Questionnaire). Based on a sample size calculation (α=0.05, β=0.80), 1045 women will be needed in each group. Analysis will be performed by the intention to treat.

Study results will contribute to establish good evidence-based routines regarding oxytocin treatment of delayed labour progress.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1376
• Est. completion date: October 8, 2016
• Est. primary completion date: June 9, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy nulliparous women

• singleton pregnancy

• normal pregnancy

• cephalic presentation

• spontaneous onset of active labour

• at term (37 - 42weeks gestation)

• delay or arrest of active labour

Exclusion Criteria:

• Non-Swedish speaking women

• previous uterine surgery

• intrauterine growth retardation > - 22%

• malpresentation at time of inclusion

• intrapartal hemorrhage at time of inclusion

• nonreassuring fetal-heart pattern at time of inclusion

• meconium at time of inclusion

Related Conditions & MeSH terms

• Birth; Delayed

Intervention

Drug:
• Oxytocin

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Göteborg
Sweden	NU Hospital Group	Trollhättan

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caesarean delivery rate	data from clinical records	At birth
Secondary	Spontaneous vaginal birth rate	data from clinical records	At birth
Secondary	Length of labour	data from clinical records	At birth
Secondary	Hyper-stimulation of contractions	data from clinical records	At birth
Secondary	Postpartum haemorrhage	data from clinical records	Two hours postpartum
Secondary	Sphincter lacerations	data from clinical records	At birth
Secondary	Epidural analgesia	data from clinical records	At birth
Secondary	Experienced labour pain	VAS 0-100 mm where 100 is highest pain level	Two hours postpartum
Secondary	Childbirth experience	Childbirth Experience Questionnaire (CEQ)	1 month postpartum
Secondary	Apgar score	data from clinical records	Five minutes postpartum
Secondary	Neonatal intensive care	data from clinical records	1 month postpartum