Labour dystocia in obese nulliparas Pregnancy and Childbirth
Conditions
Interventions
Recruitment
Potentially eligible nulliparas in spontaneous labour and labour dystocia with the decision made to augment labour with oxytocin will be further screened for eligibility for trial particip
Sponsors
University Malaya Medical Centre
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. BMI =27.5 kg/m2 2. Spontaneous labour (contraction >2:10 minutes and cervical dilatation =3cm) 3. Inadequate progress as clinically determined 4. Nulliparous (no previous pregnancy =22 weeks) 5. Term =37 weeks 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 for labour induction) 2. Previous uterine scar (caesarean/myomectomy/perforation) 3. Known major fetal anomaly 4. Fetal weight clinically estimated to be =2 kg and =4 kg and confirmed by ultrasound
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time interval from the start of oxytocin augmentation to the birth measured using data collected from the patient's electronic medical record at one timepoint | — |
Secondary
| Measure | Time frame |
|---|---|
| Performance and safety secondary outcomes partly derived from the core outcome set for reporting trials on induction of labour (CROWN) Maternal secondary outcomes: 1. Maximum oxytocin infusion rate used measured using data collected from the patient's electronic medical record after delivery 2. Duration of oxytocin infusion measured using data collected from the patient's electronic medical record after delivery 3. Total volume infused measured using data collected from the infusion pump record or patient's electronic medical record after delivery 4. Cardiotocographic abnormality through the first stage of labour as defined below measured using data from a blinded assessor after delivery, as follows: 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 measured using data collected from the patient's electronic medical record after delivery 6. Mode of delivery measured using data collected from the patient's electronic medical record after delivery, as follows: 6.1. Spontaneous 6.2. Vacuum 6.3. Forceps 6.4. Caesarean section 7. Indication for the Caesarean section measured using data collected from the patient's electronic medical record after delivery 8. Indication for instrumental vaginal delivery measured using data collected from the patient's electronic medical record after delivery 9. Maternal satisfaction with the birth process measured using the 11-point 0-10 numerical rating scale [NRS] after delivery 10. Blood loss during delivery measured using data collected from the patient's electronic medical record after delivery 11. Third- or fourth-degree tear measured using data collected from the patient's electronic medical record after delivery 12. Maternal fever measured using data coll | — |
Countries
Malaysia
Contacts
Public ContactThai Ying Wing
Outcome results
None listed