Operative vaginal delivery accompanied by a birth companion

Operative vaginal delivery with a birth companion: a randomized control trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12384479

Enrollment

132

Registered

2024-05-09

Start date

2024-06-01

Completion date

Unknown

Last updated

2024-05-21

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

Conditions

Operative vaginal delivery Pregnancy and Childbirth

Interventions

Patients in early labour will be screened for their eligibility to participate. Potentially eligible patients will be approached, provided with the patient information sheet, and verbally engaged on t

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. A birth companion was already present during the labour 2. Birth companion willing to be present at operative vaginal delivery if so randomised 3. Singleton pregnancy 4. Term gestation >36 weeks 5. Age =18 years 6. Able to communicate in Malay or English 7. Final inclusion criteria: Women who required operative vaginal delivery

Exclusion criteria

Exclusion criteria: 1. Breech presentation 2. Intrauterine death 3. Participants who refused to be accompanied by their birth companions for operative vaginal delivery 4. Major fetal anomaly

Design outcomes

Primary

Measure	Time frame
Satisfaction with the operative vaginal birth experience, scored using the 0-10 numerical rating scale [NRS], a low score indicating less satisfaction within 24 hours of delivery, by the: 1. Participant 2. Birth companion 3. Surgeon-care provider Recorded at a single timepoint right after delivery	—

Secondary

Measure	Time frame
Recorded at a single timepoint right after delivery: 1. Time it takes to deliver (insertion of the instrument to delivery of the baby as recorded in the medical record) 2. Mode of delivery (as recorded in the medical record) 3. Change of instrument for operative delivery (as recorded in the medical record) 4. Perineal injury sustained (as recorded in the medical record) 5. Estimated delivery blood loss (as recorded in the medical record) 6. Perineal pain on movement on Day 1 measured with a 0-10 NRS (obtained the day following delivery) 7. Neonatal outcomes: 7.1. Apgar score at 1 and 5 minutes (as recorded in the medical record) 7.2. Umbilical cord artery pH and base excess (as recorded in the medical record) 7.3. Neonatal injury (as recorded in the medical record) 7.4. Neonatal admission and indication (as recorded in the medical record) 7.5. Time to first satisfactory breastfeeding episode (maternally self-defined, time and date recorded as soon as soon as reported)	—

Measure

Time frame

Recorded at a single timepoint right after delivery: 1. Time it takes to deliver (insertion of the instrument to delivery of the baby as recorded in the medical record) 2. Mode of delivery (as recorded in the medical record) 3. Change of instrument for operative delivery (as recorded in the medical record) 4. Perineal injury sustained (as recorded in the medical record) 5. Estimated delivery blood loss (as recorded in the medical record) 6. Perineal pain on movement on Day 1 measured with a 0-10 NRS (obtained the day following delivery) 7. Neonatal outcomes: 7.1. Apgar score at 1 and 5 minutes (as recorded in the medical record) 7.2. Umbilical cord artery pH and base excess (as recorded in the medical record) 7.3. Neonatal injury (as recorded in the medical record) 7.4. Neonatal admission and indication (as recorded in the medical record) 7.5. Time to first satisfactory breastfeeding episode (maternally self-defined, time and date recorded as soon as soon as reported)

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Countries

Malaysia

Contacts

Public ContactNur Hamizah Binti Mohamad

hamizah.m@ummc.edu.my+60 (0)12-5195020

Outcome results

None listed

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