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

Not Applicable

• Conditions: Spontaneous labour; Pregnancy and Childbirth

• Registration Number: ISRCTN45419905
• Lead Sponsor: niversity Malaya Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-18
• Last Update Posted: 30 October 2023
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 254

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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