Placenta PreviaNCT07830914
ERAS Protocol for Cesarean Delivery in Women With Placenta Previa
A study testing Enhanced Recovery After Surgery Protocol and Conventional perioperative care in people with Placenta Previa, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Placenta Previa
- What is being tested?
- Enhanced Recovery After Surgery Protocol and Conventional perioperative care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2026to 10 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton pregnancy
- Sonographic diagnosis of placenta previa
- Scheduled for elective cesarean delivery
- Ability to provide informed consent
Who cannot join
- Severe medical diseases affecting postoperative recovery including hypertension and diabetes mellitus
- Hemodynamic instability before surgery
- ICU admission immediately after surgery
- Refusal to participate
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Enhanced Recovery After Surgery Protocol on Maternal Recovery Patient Satisfaction and Length of Hospital Stay Following Cesarean Delivery in Women With Placenta Previa
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.
Read the detailed description
Placenta previa is associated with significant maternal morbidity and prolonged hospitalization. Enhanced Recovery After Surgery pathways include patient education preoperative fasting optimization multimodal analgesia early oral intake early mobilization and early urinary catheter removal. This prospective study will include women with singleton pregnancy and sonographic diagnosis of placenta previa scheduled for elective cesarean delivery at Assiut University Hospital. Group A will receive ERAS pathway and Group B will receive conventional care. Outcomes including length of hospital stay postoperative pain time to ambulation time to oral intake and patient satisfaction will be compared.
- Conditions
- Placenta Previa
- Being tested
- Enhanced Recovery After Surgery Protocol, Conventional perioperative care
- Keywords
- Patient satisfaction, ERAS, Enhanced Recovery, Placenta Previa, Length of stay, Assiut
- Medical subject headings
- Placenta Previa, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Enhanced Recovery After Surgery Protocol |
| Conventional Care Group | Active comparator | Women managed with routine perioperative care currently practiced in the department Receives: Other: Conventional perioperative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Duration of hospital stay measured in hours from end of cesarean delivery to hospital discharge
Measured: Up to 7 days
Secondary outcomes (8)
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
Measured: At 6 hours after surgery
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
Measured: At 24 hours after surgery
Time to first ambulation
Time in hours from end of surgery to first ambulation
Measured: Up to 48 hours
Time to first oral intake
Time in hours from end of surgery to first oral fluid intake
Measured: Up to 24 hours
Time to urinary catheter removal
Time in hours from end of surgery to Foley catheter removal
Measured: Up to 48 hours
Postpartum hemorrhage
Number of participants who develop postpartum hemorrhage with blood loss greater than 1000 milliliters
Measured: Up to 24 hours
Requirement for blood transfusion
Number of participants who require packed red blood cells transfusion
Measured: Up to 7 days
Patient satisfaction score
Score on the Quality of Recovery-15 questionnaire scale ranges from 0 to 150 with higher scores indicating better recovery and satisfaction
Measured: At 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion25 Sep 2027 (estimated)
- Study completion10 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta PreviaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mostafa Adly Embaby, Assiut University
- Investigators
- Ahmed A Abdel-Aleem, prof, Study chair, Department of Obstetrics and Gynecology Assiut University Hospital Assiut Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830914
- Sponsor's protocol ID
- ERAS-PlacentaPrevia-Assiut-27
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Enhanced Recovery After Surgery Protocol on Maternal Recovery Patient Satisfaction and Length of Hospital Stay Following Cesarean Delivery in Women With Placenta Previa
- ClinicalTrials.gov ID
- NCT07830914
- Acronym / sponsor ID
- ERAS-PlacentaPrevia-Assiut-27
- Conditions
- Placenta Previa
- Keywords
- Patient satisfaction, ERAS, Enhanced Recovery, Placenta Previa, Length of stay, Assiut
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 25 Sep 2027 (estimated)
- Study completion
- 10 Mar 2028 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Placenta previa is associated with significant maternal morbidity and prolonged hospitalization. Enhanced Recovery After Surgery pathways include patient education preoperative fasting optimization multimodal analgesia early oral intake early mobilization and early urinary catheter removal. This prospective study will include women with singleton pregnancy and sonographic diagnosis of placenta previa scheduled for elective cesarean delivery at Assiut University Hospital. Group A will receive ERAS pathway and Group B will receive conventional care. Outcomes including length of hospital stay postoperative pain time to ambulation time to oral intake and patient satisfaction will be compared.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS Group | Experimental | Other: Enhanced Recovery After Surgery ProtocolWomen 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 |
| Conventional Care Group | Active comparator | Other: Conventional perioperative careWomen managed with routine perioperative care currently practiced in the department |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Singleton pregnancy
- Sonographic diagnosis of placenta previa
- Scheduled for elective cesarean delivery
- Ability to provide informed consent
Key exclusion criteria (4 listed)
- Severe medical diseases affecting postoperative recovery including hypertension and diabetes mellitus
- Hemodynamic instability before surgery
- ICU admission immediately after surgery
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Recovery After Surgery ProtocolStandardized 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. | Other | ERAS Group |
| Conventional perioperative careRoutine 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. | Other | Conventional Care Group |
Primary outcome
Length of hospital stay
Time frame: Up to 7 days
Duration of hospital stay measured in hours from end of cesarean delivery to hospital discharge
8 secondary outcomes
Postoperative pain score at 6 hours
Time frame: At 6 hours after surgery
Postoperative pain score at 24 hours
Time frame: At 24 hours after surgery
Time to first ambulation
Time frame: Up to 48 hours
Time to first oral intake
Time frame: Up to 24 hours
Time to urinary catheter removal
Time frame: Up to 48 hours
Postpartum hemorrhage
Time frame: Up to 24 hours
Requirement for blood transfusion
Time frame: Up to 7 days
Patient satisfaction score
Time frame: At 24 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmed A Abdel-Aleem, prof study chair
Department of Obstetrics and Gynecology Assiut University Hospital Assiut Egypt
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Recovery After Surgery Protocol and Conventional perioperative care in people with Placenta Previa, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed M Adly, Resident (01015727207, Ahmed.18313583@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: Up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.