Routine vaginal examination after 4 compared to 8 hours following diagnosis of early spontaneous labour in women who have previously given birth

Routine vaginal examination at 4 vs 8 hours in multiparous women in early spontaneous labour: a randomised controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN45419905

Enrollment

254

Registered

2023-10-18

Start date

2023-10-21

Completion date

Unknown

Last updated

2025-01-28

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

Conditions

Spontaneous labour Pregnancy and Childbirth

Interventions

Participants are randomly assigned to arms using sealed envelope. A. Routine vaginal examination 4 hours after the last vaginal examination B. Routine vaginal examination 8 hours after the last vagin

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Multiparous women (at least one vaginal birth =24 weeks) 2. Spontaneous labour 2.1. Cervical dilatation 3-5 cm 2.2. Painful contractions =3 in 10 minutes 3. As soon as possible after last vaginal examination (within two hours) 4. Reassuring fetal cardiotocography (CTG) 5. Singleton pregnancy 6. Cephalic presentation 7. Gestational age of = 37 weeks 8. 18 years old and above

Exclusion criteria

Exclusion criteria: 1. Previous uterine trauma (caesarean, myomectomy, perforation) 2. Major fetal malformation 3. Chorioamnionitis 4. Severe preeclampsia 5. Non-reassuring maternal status 6. Contraindication for vaginal delivery

Design outcomes

Primary

Measure	Time frame
1. Last vaginal examination before randomization to delivery interval (hours) measured using patient records at the end of the study 2. Maternal satisfaction with the allocated vaginal examination regimen in labour measured as soon as possible on the postnatal ward and before their discharge: 2.1. Rate using a 11-point Visual Numerical Scale their satisfaction with allocated intervention of vaginal examination at 4 or 8 hours 2.2. 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	—

Measure

Time frame

1. Last vaginal examination before randomization to delivery interval (hours) measured using patient records at the end of the study 2. Maternal satisfaction with the allocated vaginal examination regimen in labour measured as soon as possible on the postnatal ward and before their discharge: 2.1. Rate using a 11-point Visual Numerical Scale their satisfaction with allocated intervention of vaginal examination at 4 or 8 hours 2.2. 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

—

Secondary

Measure	Time frame
Maternal outcomes measured using patient records at the end of the study: 1. Mode of delivery (spontaneous vaginal, vacuum, forceps and caesarean) and indication of operative delivery (vacuum, forceps and caesarean) 2. Epidural analgesia in labour 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 11. Number of vaginal examinations during study period (randomisation to delivery) 12. Time (from index vaginal examination at recruitment) to 12.1. First subsequent vaginal examination 12.2. Second stage Neonatal outcomes measured using patient records at the end of the study: 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

Maternal outcomes measured using patient records at the end of the study: 1. Mode of delivery (spontaneous vaginal, vacuum, forceps and caesarean) and indication of operative delivery (vacuum, forceps and caesarean) 2. Epidural analgesia in labour 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 11. Number of vaginal examinations during study period (randomisation to delivery) 12. Time (from index vaginal examination at recruitment) to 12.1. First subsequent vaginal examination 12.2. Second stage Neonatal outcomes measured using patient records at the end of the study: 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

—

Countries

Malaysia

Contacts

Public ContactTan Peng Chiong

pctan@ummc.edu.my+60 3-79494422 (ext 2464)

Outcome results

None listed

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