Fixed-Interval vs. On-Demand Analgesia After Vacuum-Assisted Delivery: RCT

Study Objectives:

• Primary Objective: Compare the effectiveness of scheduled versus on-demand pain relief protocols following vacuum-assisted delivery during the first 24 hours postpartum, using the VAS (Visual Analog Scale) for pain (1-10).
• Secondary Objectives:

• Measure VAS scores every 8 hours during the first 24 hours postpartum.
• Assess the use of pain relief beyond 24 hours postpartum, including the use of morphine.
• Evaluate breastfeeding rates, satisfaction with the birth experience, and length of postpartum hospitalization.

Study Design:

• Recruitment: Women will be recruited immediately after vacuum-assisted delivery.
• Participants will provide informed consent and be assigned a unique anonymous identifier for data collection.
• All participants will receive 1,000 mg of IV acetaminophen immediately postpartum, per departmental protocol.
• Participants will be randomized (1:1) into two groups:

• Scheduled Pain Relief Group: Oral acetaminophen (1 g) and diclofenac (50 mg) every 8 hours for the first 24 hours postpartum.
• On-Demand Pain Relief Group: The same oral medications as the scheduled group but administered only upon request.
• After the first 24 hours postpartum, both groups will receive pain relief on-demand.
• Women experiencing breakthrough pain despite their assigned protocol will receive additional medication as needed, and such interventions will be recorded.

Pain Assessment:

Pain levels will be assessed using the VAS scale every 8 hours, and one hour before and after administering pain relief.

Data Collection:

• Demographics: Age, BMI, parity, gestational age at delivery.
• Delivery details:

• Mode of labor onset (spontaneous or induced).
• Cervical ripening method (prostaglandins or balloon).
• Use of oxytocin during labor.
• Duration of active and second stages of labor.
• Use of epidural anesthesia.
• Perineal tears (grades 1-4).
• Estimated and excessive blood loss.
• Placental separation (manual removal or uterine exploration).
• Neonatal weight.
• Outcomes:

• Pain scores (VAS)
• Medication use
• Breastfeeding rates
• Birth satisfaction (assessed via the validated Birth Satisfaction Scale-BSS-R).

Study Population:

• Inclusion Criteria: Women aged 18-45 who underwent vacuum-assisted delivery of a singleton pregnancy.
• Exclusion Criteria:

• Allergy to acetaminophen or NSAIDs.
• Chronic pain conditions (e.g., endometriosis, fibromyalgia).
• Cesarean deliveries.
• Multiple pregnancies.

Sample Size:

Based on prior studies, 100 women per group are required to detect a 33% reduction in VAS scores (from 6 ± 2 to 4 ± 2) with 80% power and a 5% significance level. A total of 200 participants will be recruited.

Duration:

The study will run for five years. Data will be securely stored for 15 years in a locked cabinet and password-protected computer accessible only to the principal investigator.

Statistical Analysis:

Data will be analyzed using SPSS software. ANOVA will be used to compare outcomes between groups.

This study addresses a gap in literature by investigating pain management protocols specifically for vacuum-assisted deliveries, aiming to improve postpartum care and maternal satisfaction.

Inclusion criteria

Women aged 18-45 who underwent vacuum-assisted delivery of a singleton pregnancy.

Exclusion criteria

• Allergy to acetaminophen or NSAIDs.
• Chronic pain conditions (e.g., endometriosis, fibromyalgia).
• Cesarean deliveries.
• Multiple pregnancies.
• Normal vaginal delivery.