Neonatal sepsis Neonatal Diseases
Conditions
Interventions
Randomisation and blinding procedure (sealed-envelope random draw
double-blinded):
Participants will be allocated to one of the three treatment arms in a 1:1:1 ratio using a sealed-envelope randomisation process. Before recruitment begins, an independent staff membe
Sponsors
C.K. Tedam University of Technology and Applied Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Pregnant women who are in active labour, with gestational age ranging from 37 weeks to 42 weeks 2. Participants (pregnant) ready to provide informed consent, have planned vaginal delivery 3. Pregnant women with accessible medical records for both mother and infant and demonstrate willingness to adhere to the study protocol and attend subsequent follow-up appointments
Exclusion criteria
Exclusion criteria: 1. Pregnancies involving multiple gestations 2. Instances of preterm labor (defined as gestational age less than 37 weeks) 3. Scheduled cesarean deliveries 4. Established contraindications to the intrathecal administration of bupivacaine or dexamethasone 5. A documented history of maternal infections such as chorioamnionitis, syphilis, or HIV 6. Particularly in patients receiving antibiotic therapy 7. An inability to provide informed consent 8. A lack of willingness to adhere to the study protocol or attend follow-up appointments
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Duration of intrapartum analgesia measured by observation and documentation of the interval between drug administration and the point at which analgesic effect diminished; labour ward analgesia records maintained by clinical staff; continuously observed from the time of intrathecal injection until analgesia was judged to have worn off. 2. Pain severity reported by the mother during labour, measured using pain scores documented on labour monitoring forms (e.g., numerical rating scales noted in clinical records), before intrathecal administration (baseline) and at designated intervals during labour, including at peak contractions and when the block begins to wear off. 3. Final delivery outcome (spontaneous vaginal birth, assisted vaginal delivery or caesarean section), extracted from maternal obstetric records at completion of labour. 4. Standard Apgar assessment (0–10), evaluating respiratory effort, heart rate, tone, reflex irritability and colour, obtained from neonatal delivery documentation recorded at 1 minute and 5 minutes post-delivery. 5. Neonatal admission to the NICU and length of stay measured by review of neonatal clinical notes and NICU admission logs within the first 24 hours after delivery and monitored throughout the NICU stay. 6. Neonatal blood culture result (positive or negative) taken from laboratory culture reports recorded in neonatal clinical files as clinically indicated during postnatal hospitalisation. Results considered within the neonatal period (first 28 days of life). 8. Maternal age, parity, gestational age, booking status and neonatal characteristics (descriptive variables, not efficacy outcomes), extracted from maternal and neonatal clinical records at enrolment for maternal baseline information and at delivery for neonatal characteristics. | — |
Countries
Ghana
Contacts
Public ContactSylvanus Kampo
Outcome results
None listed