NCT07830914

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
18mo left

Started Sep 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Sep 2026Mar 2028

First Submitted

Initial submission to the registry

September 15, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

September 20, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2028

Last Updated

September 22, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 15, 2026

Last Update Submit

September 18, 2026

Conditions

Placenta Previa

Keywords

Patient satisfactionERASEnhanced RecoveryPlacenta PreviaLength of stayAssiut

Outcome Measures

Primary Outcomes (1)

  • Length of hospital stay

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

    Up to 7 days

Secondary Outcomes (8)

  • Postoperative pain score at 6 hours

    At 6 hours after surgery

  • Postoperative pain score at 24 hours

    At 24 hours after surgery

  • Time to first ambulation

    Up to 48 hours

  • Time to first oral intake

    Up to 24 hours

  • Time to urinary catheter removal

    Up to 48 hours

  • +3 more secondary outcomes

Study Arms (2)

ERAS Group

EXPERIMENTAL

Women managed according to the standardized ERAS pathway including preoperative education fasting 2 hours for clear fluids multimodal analgesia early oral intake early mobilization and early urinary catheter removal

Other: Enhanced Recovery After Surgery Protocol

Conventional Care Group

ACTIVE COMPARATOR

Women managed with routine perioperative care currently practiced in the department

Other: Conventional perioperative care

Interventions

Enhanced Recovery After Surgery ProtocolOTHER

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.

ERAS Group
Conventional perioperative careOTHER

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.

Conventional Care Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Singleton pregnancy
  • Sonographic diagnosis of placenta previa
  • Scheduled for elective cesarean delivery
  • Ability to provide informed consent

You may not qualify if:

  • Severe medical diseases affecting postoperative recovery including hypertension and diabetes mellitus
  • Hemodynamic instability before surgery
  • ICU admission immediately after surgery
  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Placenta PreviaPatient Satisfaction

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Ahmed A Abdel-Aleem, prof

    Department of Obstetrics and Gynecology Assiut University Hospital Assiut Egypt

    STUDY CHAIR

Central Study Contacts

Ahmed M Adly, Resident

CONTACT

01015727207Ahmed.18313583@med.aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician, Obstetrics and Gynecology department

Study Record Dates

First Submitted

September 15, 2026

First Posted

September 21, 2026

Study Start

September 20, 2026

Primary Completion (Estimated)

September 25, 2027

Study Completion (Estimated)

March 10, 2028

Last Updated

September 22, 2026

Record last verified: 2026-09