Does 8 hourly vaginal examination interval after amniotomy and cervical ripening with Foley's catheter in women with firstborn baby improve maternal satisfaction during labour?

Category Primary study
Registry of TrialsISRCTN registry
Year 2021
INTERVENTION: All women who fulfilled the inclusion criteria undergoing induction via Foley catheter insertion are identified by health care providers at the delivery suite and antenatal ward. will be assessed for recruitment eligibility by going through their medical records when they attending their scheduled induction of labour in our obstetric unit. Participants who fulfilled the eligibility criteria will be provided with a patient information sheet and counselled for participation in this study. If women agree to participate, written and informed consent will be taken from participants. Following removal of foley’s catheter, manually or spontaneously, the vaginal examination will be performed and participants with cervical dilatation = 3cm will be sent to labour ward for amniotomy. If participants fulfilled the final criteria; (i) cervical os dilatation of = 3cm, (ii) cephalic presentation, (iii) station not higher than ‐2, (iv) reassuring fetal heart status, randomization will be performed post amniotomy. Titration of intravenous oxytocin augmentation is at the discretion of the care provider. Randomization will be carried out by opening the lowest‐numbered seal opaque envelope. Randomization for 1:1 ratio with blocks of 4 and 8 done by an investigator not involved in the recruitment process will be used to generate the randomization code. Participants will be randomized to either the intervention group (Group 1) or the control group (Group 2). Participants in the intervention group will be subjected to 8 hourly routine vaginal examination while participants in the control group will be subjected to standard 4 hourly routine vaginal examination during labour. Participants on both groups will require additional CONDITION: Maternal satisfaction with induction of labor ; Pregnancy and Childbirth PRIMARY OUTCOME: ; 1. Maternal satisfaction of labour care measured using a Visual Numerical Rating Score (VNRS) from 0‐10, assessed soon after delivery; 2. Duration of active labour, defined as amniotomy to delivery interval is assessed from hospital records after hospital discharge; INCLUSION CRITERIA: 1. Women who had cervical ripening with Foley catheter only and favourable cervix with cervical dilatation of 3cm or greater (suitable for amniotomy) with contraction <1:5min 2. Nulliparous 3. No prior pregnancy beyond 20 weeks gestation 4. Age 18 years and above 5. Gestational age of =37weeks at enrolment scheduled induction of labour 6. Scheduled induction of labour 7. Viable pregnancy 8. Cephalic presentation 9. Singleton pregnancy 10. Reassuring pre induction fetal cardiotocography (CTG) 11. Intact membrane SECONDARY OUTCOME: ; Current secondary outcome measures as of 09/06/2021:; ; Maternal outcomes:; 1. Mode of delivery; 2. Indication for caesarean and operative vaginal delivery; 3. Oxytocin induction/augmentation in labour; 4. Fever which is defined from as single temperature reading of 38°C or greater; 4.1. Intrapartum; 4.2. Post‐partum; 5. Analgesic & epidural used in labour; 6. Estimated delivery blood loss; 7. Uterine hyperactivity:; 7.1. Tachysystole (six of more contractions in 10 minutes over two consecutive 10‐minute periods); 7.2. Hypertonus (sustained contraction 2 min or longer); 7.3. Hypertonus with fetal heart rate abnormality; 8. CTG abnormality based on NICE guideline; 9. Duration of hospital stay from time of induction until discharge; *Indication for induction of labour have been removed from secondary outcome but the data will be captured and recorded in the data collection form; ; Neonatal outcomes:; 1. Apgar score at 1 and 5 minutes; 2. Umbilical cord arterial blood pH and base excess; 3. Birth weight; 4. Neonatal admission (NICU/Special care nursery/Indication for neonatal admission); ; _____; ; Previous secondary outcome measures:; ; Measured using patient records after birth:; Maternal outcomes:; 1. Caesarean section rate & Indication for caesarean section; 2. Operative vagina delivery Indication; 3. Oxytocin induction/augmentation in labour; 4. Fever which is defined from as single temperature reading of 38°C or greater; 5. Analgesic & epidural used in labour; 6. Estimated delivery blood loss; 7. Uterine hyperactivity:; 7.1. Tachysystole (six of more contractions in 10 minutes over two consecutive 10‐minute periods); 7.2. Hypertonus (sustained contraction 2 min or longer); 7.3. Hypertonus with fetal heart rate abnormality; 8. CTG abnormality based on NICE guideline; 9. Duration of hospital stay from time of induction until discharge; 10. Indication for induction of labour; ; Neonatal outcomes:; 1. Apgar score at 1 and 5 minutes; 2. Umbilical cord arterial blood pH and base excess; 3. Birth weight; 4. Neonatal admission (NICU/Special care nursery/Indication for neonatal admission);
Epistemonikos ID: 088351655b70b6d7928a2b9fee1696ef00a8d10f
First added on: Aug 25, 2024