Labour dystocia (abnormal labour progress) Pregnancy and Childbirth
Conditions
Interventions
A randomisation sequence is generated using an online randomiser in blocks of 4 or 8 (1-to-1 ratio) by an investigator not involved in study recruitment. Participants will be randomised by the opening
Sponsors
University Malaya Medical Centre
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. BMI =27.5 kg/m2 (Asian definition of obesity) 2. Spontaneous labour (contraction >2:10 minutes and cervical dilatation =3cm) 3. Inadequate progress as clinically determined 4. Multiparous (at least one prior vaginal delivery) 5. Term =37 weeks gestation 6. Age 18-45 years old 7. Membranes ruptured (including prelabour rupture of membranes) 8. Singleton pregnancy 9. Cephalic presentation 10. Reassuring fetal heart rate tracing at initiation of oxytocin infusion
Exclusion criteria
Exclusion criteria: 1. Induced labour (prior Foley, prostaglandin or oxytocin) 2. Previous uterine scar (caesarean/myomectomy/perforation) 3. Known major fetal anomaly 4. Fetal weight clinically estimated to be =2 kg & =4 kg and subsequently confirmed by ultrasound 5. Grand multiparous (parity =5)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Start of oxytocin infusion to birth interval measured using data collected from the patient's electronic medical record at one timepoint | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome measures were assessed from data collected from the electronic medical record at one timepoint, unless stated: 1. Maximum oxytocin infusion rate used 2. Duration of oxytocin infusion 3. Total volume infused 4. Cardiotocographic abnormality (through first stage of labour)-assessed by a blinded assessor 4.1. Tachysystole (contractions =6 in 10 minutes) 4.2. Hypertonus (sustained contraction =2 minutes) 4.3. Hyperstimulation syndrome (tachysystole and/or hypertonus with concurrent fetal deceleration [defined as a decrease in fetal heart rate of =15 bpm from baseline for =15 seconds]) 5. Number of doses of tocolytic given, if any 6. Mode of delivery 6.1. Spontaneous vaginal 6.2. Vacuum 6.3. Forceps 6.4. Caesarean section 7. Indication for caesarean section 8. Indication for instrumental vaginal delivery 9. Maternal satisfaction with the birth process measured using an 11-point 0-10 NRS – numerical rating scale, after delivery (higher score, greater satisfaction) 10. Blood loss during delivery 11. Third- or fourth-degree tear 12. Maternal infection 13. Intrapartum therapeutic antibiotics (excluding prophylactic antibiotics) 14. Epidural in labour 15. Length of hospital stay 16. ICU admission 17. Cardiorespiratory arrest 18. Needing a hysterectomy 19. Neonatal outcomes 19.1. Apgar score at 1 and 5 minutes 19.2. NICU admission 19.3. Cord pH 19.4. Neonatal sepsis 19.5. Birth weight 19.6. Birth trauma 19.7. Hypoxic ischaemic encephalopathy/need for therapeutic hypothermia Major harm 20. Neonatal hypoxic ischaemic-encephalopathy requiring cooling therapy due to uterine hyperstimulation syndrome 21. Maternal convulsions due to water intoxication | — |
Countries
Malaysia
Contacts
Public ContactMuhammad Ariff;Tan Saari;Peng Chiong
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Outcome results
None listed