Vaginal examination performed routinely at 8 hours or at 4 hours after starting the oxytocin drip to augment the labour of women delivering their first child

Vaginal examination at 8 hours compared to 4 hours after commencement of oxytocin augmentation in nulliparous women: a randomized controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN77253756

Enrollment

248

Registered

2023-11-03

Start date

2023-12-30

Completion date

Unknown

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oxytocin augmentation of labour Pregnancy and Childbirth

Interventions

Randomization is done by opening the lowest number, sealed and opaque envelope that is available. The randomization sequence will be generated using a random number generator in random blocks of 4 or

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Spontaneous labour 2. Nulliparous (no prior pregnancy >22 weeks) 3. Singleton pregnancy 4. Gestational age of =37 weeks 5. 18 years old and above 6. Cervical dilatation at <6 cm 7. Oxytocin augmentation for labour delay actioned and started

Exclusion criteria

Exclusion criteria: 1. Abnormal fetal heart rate tracing 2. Previous uterine trauma (myomectomy, hysterotomy, perforation) 3. Major fetal malformation 4. Meconium staining of liquor 5. Chorioamnionitis 6. Severe preeclampsia 7. Non-reassuring maternal status 8. Contraindication for vaginal delivery

Design outcomes

Primary

Measure	Time frame
1. Augmentation to delivery interval measured after delivery, calculated from the recorded date and time of the start of oxytocin augmentation and date and time of birth, variable will be in hours. 2. Maternal satisfaction with the allocated vaginal examination regimen, obtained as soon as possible on the postnatal ward and before their discharge, participants will be asked: 2.1. To rate using an 11-point (0-10) (visual numerical rating scale - VNRS) their satisfaction with the allocated intervention of vaginal examination at 4 or 8 hours 2.2. To provide a response using a 5-grade Likert scale on if they will recommend their allocated intervention of vaginal examination at 4 or 8 hours to a friend, graded from strongly agree, agree, neither agree nor disagree, disagree to strongly disagree	—

Measure

Time frame

1. Augmentation to delivery interval measured after delivery, calculated from the recorded date and time of the start of oxytocin augmentation and date and time of birth, variable will be in hours. 2. Maternal satisfaction with the allocated vaginal examination regimen, obtained as soon as possible on the postnatal ward and before their discharge, participants will be asked: 2.1. To rate using an 11-point (0-10) (visual numerical rating scale - VNRS) their satisfaction with the allocated intervention of vaginal examination at 4 or 8 hours 2.2. To provide a response using a 5-grade Likert scale on if they will recommend their allocated intervention of vaginal examination at 4 or 8 hours to a friend, graded from strongly agree, agree, neither agree nor disagree, disagree to strongly disagree

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Secondary

Measure	Time frame
Recorded directly onto the case report form. Information not in the case report form will be acquired from hospital charts or notes. Maternal outcomes assessed at birth: 1. Mode of delivery (spontaneous vaginal, vacuum, forceps and caesarean) and indication of operative delivery (vacuum, forceps and caesarean) 2. Epidural analgesia 3. Estimated delivery blood loss 4. Fever with temperature =38ºC or greater (intrapartum to hospital discharge) 5. Maternal recommendation of allocated intervention to a friend (5-point Likert scale) 6. Maternal ICU admission 7. Hysterectomy 8. Relaparotomy 9. Vaginal examination as scheduled 10. Interim vaginal examination (and indication) 11. Number of vaginal examinations during the study period (to delivery) 12. Time (from index vaginal examination at recruitment) to 13. First subsequent vaginal examination 14. Diagnosis of second stage 15. Birth 16. Hospital discharge Neonatal outcomes assessed at birth: 1. Apgar score at 1 and 5 minutes 2. Birth weight 3. Neonatal admission (and indication ) 4. Cord pH 5. Birth trauma (specify) 6. Hypoxic ischaemic encephalopathy/need for therapeutic hypothermia	—

Measure

Time frame

Recorded directly onto the case report form. Information not in the case report form will be acquired from hospital charts or notes. Maternal outcomes assessed at birth: 1. Mode of delivery (spontaneous vaginal, vacuum, forceps and caesarean) and indication of operative delivery (vacuum, forceps and caesarean) 2. Epidural analgesia 3. Estimated delivery blood loss 4. Fever with temperature =38ºC or greater (intrapartum to hospital discharge) 5. Maternal recommendation of allocated intervention to a friend (5-point Likert scale) 6. Maternal ICU admission 7. Hysterectomy 8. Relaparotomy 9. Vaginal examination as scheduled 10. Interim vaginal examination (and indication) 11. Number of vaginal examinations during the study period (to delivery) 12. Time (from index vaginal examination at recruitment) to 13. First subsequent vaginal examination 14. Diagnosis of second stage 15. Birth 16. Hospital discharge Neonatal outcomes assessed at birth: 1. Apgar score at 1 and 5 minutes 2. Birth weight 3. Neonatal admission (and indication ) 4. Cord pH 5. Birth trauma (specify) 6. Hypoxic ischaemic encephalopathy/need for therapeutic hypothermia

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Countries

Malaysia

Contacts

Public ContactTan Peng Chiong

pctan@um.edu.my+60 (0)12 3052970

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026