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ERAS Protocol for Cesarean Delivery in Women With Placenta Previa

ConditionPlacenta Previa
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorAssiut University

About this trial

This study aims to evaluate the impact of Enhanced Recovery After Surgery protocols on maternal outcomes patient satisfaction and length of hospital stay following cesarean delivery in women with placenta previa. Women scheduled for elective cesarean delivery for placenta previa will be managed either with a standardized ERAS pathway or with conventional routine perioperative care.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Singleton pregnancy

Sonographic diagnosis of placenta previa

Scheduled for elective cesarean delivery

Ability to provide informed consent

Disqualifiers

Severe medical diseases affecting postoperative recovery including hypertension and diabetes mellitus

Hemodynamic instability before surgery

ICU admission immediately after surgery

Refusal to participate

Trial design

Design model

Parallel

Treatments tested in this trial

  • Enhanced Recovery After Surgery Protocol

    Other intervention

    Standardized ERAS pathway for cesarean delivery including preoperative counseling, clear fluids allowed up to 2 hours and solid food fasting for 6 hours, optimization of hemoglobin, multimodal analgesia with scheduled acetaminophen and nonsteroidal anti-inflammatory drugs with limited opioids, prophylaxis for postoperative nausea and vomiting, early oral fluid and solid intake, early mobilization with sitting and standing and ambulation within 6 to 12 hours, early Foley catheter removal within 12 hours when clinically feasible, and standardized discharge planning. This intervention is applied only to the Experimental Arm.

  • Conventional perioperative care

    Other intervention

    Routine conventional perioperative care currently practiced at Assiut University Hospital including traditional preoperative fasting, standard analgesia, usual timing of oral intake, mobilization and urinary catheter removal according to physician preference.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: ERAS GroupExperimental treatment 1 intervention
Group B: Conventional Care GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Length of hospital stay

Duration of hospital stay measured in hours from end of cesarean delivery to hospital discharge

Time frame
Up to 7 days

Secondary outcomes

1

Postoperative pain score at 6 hours

Pain score assessed using 0 to 10 Visual Analogue Scale with 0 indicating no pain and 10 indicating worst imaginable pain with higher scores indicating worse pain

Time frame
At 6 hours after surgery
2

Postoperative pain score at 24 hours

Pain score assessed using 0 to 10 Visual Analogue Scale with 0 indicating no pain and 10 indicating worst imaginable pain with higher scores indicating worse pain

Time frame
At 24 hours after surgery
3

Time to first ambulation

Time in hours from end of surgery to first ambulation

Time frame
Up to 48 hours
4

Time to first oral intake

Time in hours from end of surgery to first oral fluid intake

Time frame
Up to 24 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: