Internal examination in women with previous delivery during labour

Randomised controlled trial of 4 hours versus 8 hours vaginal examination intervals after amniotomy and cervical ripening with Foleys catheter in multiparous women

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15309710

Enrollment

202

Registered

2021-10-07

Start date

2021-10-11

Completion date

Unknown

Last updated

2024-11-18

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

Conditions

Multiparous women after induction with Foleys catheter and amniotomy induction of labour Pregnancy and Childbirth

Interventions

All potential candidates for planned induction of labour who fulfil the inclusion criteria are identified by health care providers at the delivery suite and antenatal ward. Potential candidates will b

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Multiparous women 2. Aged 18 years and above 3. Gestational age of =37 weeks at enrolment of scheduled induction of labour 4. Cephalic presentation 5. Singleton pregnancy 6. Women who had cervical ripening with Foleys catheter and favourable cervix with cervical dilatation of 3 cm or greater (suitable for amniotomy) with contraction <1:10 7. Reassuring fetal cardiotocography (CTG) tracing

Exclusion criteria

Exclusion criteria: 1. Previous uterine incision/injury (caesarean delivery, myomectomy, perforation) 2. Gross fetal anomaly 3. Contraindication for vaginal birth 4. Estimated fetal weight =4.0 kg before induction

Design outcomes

Primary

Measure	Time frame
1. Maternal satisfaction of labour care measured using a visual numerical rating score from 0-10, assessed after delivery 2. Duration of active labour, defined as the amniotomy to delivery interval	—

Secondary

Measure	Time frame
Recorded at delivery: 1. Mode of delivery - vaginal delivery or assisted delivery or caesarean section in each group, in numbers and percentage 2. Rate of caesarean section - percentage of caesarean section in each group 3. Highest intrapartum and day 1 postpartum fever, defined as a single temperature reading of =38ºC, documented as present or not 4. Analgesia used in active labour, documented as requiring analgesia or not 5. Estimated blood loss, quantified by healthcare worker attending to delivery, after delivery 6. Apgar score of baby measured at 1 and 5 minutes after birth 7. Arterial cord pH, from cord blood taken after delivery and before placenta expulsion and recorded in case report form 8. Birth weight - weight of baby in grams immediately after delivery 9. Neonatal care admission requirement within 24 hours of life, documented as requiring admission or not	—

Measure

Time frame

Recorded at delivery: 1. Mode of delivery - vaginal delivery or assisted delivery or caesarean section in each group, in numbers and percentage 2. Rate of caesarean section - percentage of caesarean section in each group 3. Highest intrapartum and day 1 postpartum fever, defined as a single temperature reading of =38ºC, documented as present or not 4. Analgesia used in active labour, documented as requiring analgesia or not 5. Estimated blood loss, quantified by healthcare worker attending to delivery, after delivery 6. Apgar score of baby measured at 1 and 5 minutes after birth 7. Arterial cord pH, from cord blood taken after delivery and before placenta expulsion and recorded in case report form 8. Birth weight - weight of baby in grams immediately after delivery 9. Neonatal care admission requirement within 24 hours of life, documented as requiring admission or not

—

Countries

Malaysia

Outcome results

None listed

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