Cesarean SectionERACNCT07720986
Enhanced Recovery Protocol After Cesarean Section
A study testing Enhanced Recovery after Cesarean protocol of Care and Routine hospital care in people with Cesarean Section, run by Mansoura University at 1 site in Egypt.
Trial summary
This study aims to evaluate the effectiveness of implementing the Enhanced Recovery After Cesarean (ERAC) protocol on maternal and neonatal outcomes. Research hypotheses To fulfill the aim of the study, the following research hypotheses are formulated: Hypothesis I: Women who receive the ERAC protocol experience… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Enhanced Recovery after Cesarean protocol of Care and Routine hospital care
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women undergoing planned cesarean delivery.
- Scheduled to receive neuraxial anesthesia.
- Gestational age of 37 weeks or more.
- Singleton pregnancy.
Who cannot join
- Women requiring additional interventions outside the Enhanced Recovery After Cesarean (ERAC) pathway, including severe coagulopathy or active infection.
- Women expected to require prolonged hospitalization because of a history of uterine rupture, pre-existing hypertension, pregnancy-induced hypertension, or placenta accreta.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Implementing Enhanced Recovery After Cesarean Section Protocol on Maternal and Neonatal Outcomes
This study aims to evaluate the effectiveness of implementing the Enhanced Recovery After Cesarean (ERAC) protocol on maternal and neonatal outcomes.
Research hypotheses
To fulfill the aim of the study, the following research hypotheses are formulated:
Hypothesis I: Women who receive the ERAC protocol experience faster recovery compared to those who receive routine hospital nursing care.
Hypothesis II: Women who receive the ERAC protocol experience fewer maternal and neonatal complications than those who receive routine hospital nursing care.
Read the detailed description
Cesarean section (CS) remains one of the most common surgical procedures in obstetric practice. Worldwide CS rates have become an important public health concern because of their implications for maternal and neonatal healthcare. In many countries, including Egypt, cesarean delivery rates have increased substantially during recent decades, often exceeding recommended levels.
Cesarean section is a lifesaving procedure when medically indicated. Common indications include fetal malpresentation, multiple pregnancy, chorioamnionitis, arrested labor, oligohydramnios, umbilical cord prolapse, cephalopelvic disproportion, eclampsia, and hemolysis, elevated liver enzymes, and low platelet count (HELLP) syndrome. Elective CS may also be influenced by fear of vaginal birth and concerns regarding labor-related complications, including pelvic organ prolapse and perineal injury.
Although CS is generally considered safe, it remains associated with several intraoperative and postoperative maternal and neonatal risks. Intraoperative maternal complications include hypotension, local anesthetic toxicity, post-dural puncture headache, nerve injury, endometritis, severe bleeding, and urinary tract or bowel injury. Postoperative complications include abdominal pain, bowel obstruction, incisional hernia, pelvic adhesions, postpartum hemorrhage, deep vein thrombosis, increased risks of placenta previa or placental abruption in subsequent pregnancies, prolonged hospitalization, delayed functional recovery, emotional distress, delayed maternal-infant bonding, and reduced patient satisfaction.
Neonatal risks associated with CS include birth injury, persistent tachypnea, respiratory distress syndrome, transient tachypnea of the newborn, low birth weight, low Apgar scores, and admission to the neonatal intensive care unit (NICU). Such complications occur more frequently after emergency CS than after elective CS or vaginal birth.
The increasing global rate of CS highlights the need to improve the quality of perioperative care provided to women undergoing cesarean delivery. Evidence-based practices emphasizing patient education, informed consent, and shared decision-making contribute to safer and more individualized maternity care. The Enhanced Recovery After Cesarean (ERAC) protocol standardizes preoperative, intraoperative, and postoperative care to improve recovery and quality of care.
The ERAC protocol includes a comprehensive set of evidence-based interventions designed to enhance maternal recovery and reduce maternal and neonatal complications. The pathway extends from the decision for cesarean delivery until hospital discharge. Preoperative care includes patient education, reduced preoperative fasting, maintenance of normothermia, and optimization of hemoglobin levels. Intraoperative care includes prophylactic antibiotics, appropriate fluid preload or co-load, phenylephrine infusion, neuraxial anesthesia with opioid-sparing analgesia, delayed cord clamping, skin-to-skin contact, and early initiation of breastfeeding.
Postoperative ERAC care includes prophylaxis for postoperative nausea and vomiting (PONV), multimodal analgesia, early oral intake, early ambulation, early urinary catheter removal, lactation support, and streamlined hospital discharge. The ERAC protocol provides an evidence-based approach to reducing surgical complications, improving maternal outcomes and functional recovery, strengthening maternal-infant bonding, enhancing patient experience, and shortening hospital length of stay.
- Conditions
- Cesarean Section
- Being tested
- Enhanced Recovery after Cesarean protocol of Care, Routine hospital care
- Keywords
- Cesarean Section, Maternal outcome, Neonatal Outcome, ERAS, ERAC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Recovery after Cesarean protocol of CareProcedure or surgery
- The intervention group will receive the Enhanced Recovery after Cesarean protocol of Care which consists of:
Preoperative Care:
- Patient education covering the procedure, perioperative expectations, pain management plan, early oral intake and mobilization goals, discharge criteria, and follow-up schedule.
- Minimizing fasting: Solid food allowed up to 6 hours and clear fluids up to 2 hours prior to surgery.
- Carbohydrate loading: Administration of 45g non-particulate carbohydrate drink up to 2 hours before surgery for non-diabetic mothers.
Intraoperative Care:
- Antibiotic prophylaxis: Administered within 60 minutes prior to skin incision.
- Thermal regulation: Use of active warming methods, warmed IV fluids, and maintaining operating room temperature >72.8°F (22.7°C).
- Anesthesia: Neuraxial anesthesia with hypotension prevention strategies (fluid preloading/co-loading and phenylephrine infusion).
- Delayed cord clamping: For 30-60 seconds after birth.
- Immediate maternal-newborn
Routine hospital careProcedure or surgery
The control group will receive routine preoperative, intraoperative, and postoperative nursing care according to standard hospital practice.
Preoperative care:
- Fasting from both food and fluids for at least 8 hours before surgery.
Intraoperative care:
- Immediate umbilical cord clamping after birth.
Postoperative care:
- Analgesia according to routine hospital practice without a standardized multimodal analgesic regimen.
- Urinary catheter removal at least 12 hours after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Experimental :ERAC arm (intervention) | Experimental | The intervention group will receive the Enhanced Recovery After Cesarean (ERAC) protocol of care, consisting of the following components:
Preoperative care:
* Patient education.
* Reduced preoperative fasting: solid food will be permitted until 6 hours before surgery, and clear fluids until 2 hours before surgery.
* Preoperative carbohydrate loading.
Intraoperative care:
* Antibiotic prophylaxis.
* Thermal regulation using active warming methods, warmed intravenous fluids, and maintenance of an appropriate operating room temperature.
* Neuraxial anesthesia with strategies to prevent maternal hypotension.
* Delayed cord clamping for 30-60 seconds after birth.
* Immediate maternal-newborn bonding through skin-to-skin contact and early initiation of breastfeeding in the operating room, when clinically feasible.
Postoperative care:
• Prophylaxis for pos Receives: Procedure: Enhanced Recovery after Cesarean protocol of Care |
| Routine care arm | Active comparator | The control group will receive routine nursing care only (pre-operative, intraoperative and postoperative).NPO for at least 8 hrs for food and fluid ,immediate cord clamping ,no mutlimodal analgesia ,catheter removal after at least 12 hrs Receives: Procedure: Routine hospital care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal quality of recovery score
Maternal quality of recovery will be measured using a 40-item questionnaire. Each item is rated on a three-point Likert scale: 1 = rarely, 2 = sometimes, and 3 = always. Scores are reversed for negatively worded items. Total scores range from 40 to 120, with higher scores indicating better quality of recovery and lower scores indicating poorer quality of recovery.
Measured: at day 0 and 2 weeks postoperative
Secondary outcomes (9)
Incidence of intraoperative hypotension
Occurrence of maternal hypotension during cesarean delivery, recorded as present or absent and reported as the number and percentage of women in each study group.
Measured: day 0 of surgery
Incidence of intraoperative nausea and vomiting
Occurrence of maternal nausea and/or vomiting during cesarean delivery, recorded as present or absent and reported as the number and percentage of women in each study group.
Measured: During cesarean delivery.
Time to first semisolid food intake
Time in hours from completion of cesarean delivery to the first intake of semisolid food.
Measured: From completion of surgery until first semisolid food intake during hospitalization.
Time to first ambulation
Time in hours from completion of cesarean delivery until the first postoperative ambulation.
Measured: From completion of surgery until first ambulation during hospitalization.
Hospital length of stay
Duration of hospitalization measured in hours from completion of cesarean delivery until hospital discharge.
Measured: From completion of surgery until hospital discharge.
Hospital readmission
Occurrence of hospital readmission due to maternal postoperative complications, recorded as present or absent and reported as the number and percentage of women in each study group.
Measured: Within 30 days after surgery.
Neonatal Outcome Measures
Neonatal condition measured using the Apgar score at 1 minute after birth. The total score ranges from 0 to 10 and will be categorized as reassuring (7-10), moderately abnormal (4-6), or low (0-3), with higher scores indicating better neonatal conditio
Measured: At 1st and 5th minute after birth.
Neonatal intensive care unit admission
Admission of the newborn to the neonatal intensive care unit, recorded as present or absent and reported as the number and percentage of newborns in each study group.
Measured: From birth until hospital discharge.
Neonatal birth weight
Neonatal birth weight measured in grams using a calibrated infant weighing scale immediately after birth.
Measured: Immediately after birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start1 Feb 2025
- Primary completion30 Sep 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- 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
- Model description
- Participants in the control group will receive the standard perioperative nursing care routinely provided at the study site, including conventional preoperative, intraoperative, and postoperative practices without a structured protocol. • The intervention group will receive the Enhanced Recovery after Cesarean protocol of Care which consists of: Preoperative Care: * Patient education covering the procedure, perioperative expectations, pain management plan, early oral intake and mobilization goals, discharge criteria, and follow-up schedule. * Minimizing fasting: Solid food allowed up to 6 hours and clear fluids up to 2 hours prior to surgery. * Carbohydrate loading: Administration of 45g non-particulate carbohydrate drink up to 2 hours before surgery for non-diabetic mothers. Intraoperative Care: * Antibiotic prophylaxis: Administered within 60 minutes prior to skin incision. * Thermal regulation: Use of active warming methods, warmed IV fluids, and maintaining operating room temperatu
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noura El-Gamel, Mansoura University
- Investigators
- Noura G El-Gamel, MSc, Principal investigator, Mansoura UniversityEnas S Fathy, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720986
- Sponsor's protocol ID
- ERAC
- Acronym
- ERAC
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the participants' informed consent and institutional ethical approval did not include external sharing of participant-level data. Aggregate study findings will be reported in scientific publications.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Implementing Enhanced Recovery After Cesarean Section Protocol on Maternal and Neonatal Outcomes
- ClinicalTrials.gov ID
- NCT07720986
- Acronym / sponsor ID
- ERAC / ERAC
- Conditions
- Cesarean Section
- Keywords
- Cesarean Section, Maternal outcome, Neonatal Outcome, ERAS, ERAC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 22 Jul 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 effectiveness of implementing the Enhanced Recovery After Cesarean (ERAC) protocol on maternal and neonatal outcomes.
Research hypotheses
To fulfill the aim of the study, the following research hypotheses are formulated:
Hypothesis I: Women who receive the ERAC protocol experience faster recovery compared to those who receive routine hospital nursing care.
Hypothesis II: Women who receive the ERAC protocol experience fewer maternal and neonatal complications than those who receive routine hospital nursing care.
Detailed description
Cesarean section (CS) remains one of the most common surgical procedures in obstetric practice. Worldwide CS rates have become an important public health concern because of their implications for maternal and neonatal healthcare. In many countries, including Egypt, cesarean delivery rates have increased substantially during recent decades, often exceeding recommended levels.
Cesarean section is a lifesaving procedure when medically indicated. Common indications include fetal malpresentation, multiple pregnancy, chorioamnionitis, arrested labor, oligohydramnios, umbilical cord prolapse, cephalopelvic disproportion, eclampsia, and hemolysis, elevated liver enzymes, and low platelet count (HELLP) syndrome. Elective CS may also be influenced by fear of vaginal birth and concerns regarding labor-related complications, including pelvic organ prolapse and perineal injury.
Although CS is generally considered safe, it remains associated with several intraoperative and postoperative maternal and neonatal risks. Intraoperative maternal complications include hypotension, local anesthetic toxicity, post-dural puncture headache, nerve injury, endometritis, severe bleeding, and urinary tract or bowel injury. Postoperative complications include abdominal pain, bowel obstruction, incisional hernia, pelvic adhesions, postpartum hemorrhage, deep vein thrombosis, increased risks of placenta previa or placental abruption in subsequent pregnancies, prolonged hospitalization, delayed functional recovery, emotional distress, delayed maternal-infant bonding, and reduced patient satisfaction.
Neonatal risks associated with CS include birth injury, persistent tachypnea, respiratory distress syndrome, transient tachypnea of the newborn, low birth weight, low Apgar scores, and admission to the neonatal intensive care unit (NICU). Such complications occur more frequently after emergency CS than after elective CS or vaginal birth.
The increasing global rate of CS highlights the need to improve the quality of perioperative care provided to women undergoing cesarean delivery. Evidence-based practices emphasizing patient education, informed consent, and shared decision-making contribute to safer and more individualized maternity care. The Enhanced Recovery After Cesarean (ERAC) protocol standardizes preoperative, intraoperative, and postoperative care to improve recovery and quality of care.
The ERAC protocol includes a comprehensive set of evidence-based interventions designed to enhance maternal recovery and reduce maternal and neonatal complications. The pathway extends from the decision for cesarean delivery until hospital discharge. Preoperative care includes patient education, reduced preoperative fasting, maintenance of normothermia, and optimization of hemoglobin levels. Intraoperative care includes prophylactic antibiotics, appropriate fluid preload or co-load, phenylephrine infusion, neuraxial anesthesia with opioid-sparing analgesia, delayed cord clamping, skin-to-skin contact, and early initiation of breastfeeding.
Postoperative ERAC care includes prophylaxis for postoperative nausea and vomiting (PONV), multimodal analgesia, early oral intake, early ambulation, early urinary catheter removal, lactation support, and streamlined hospital discharge. The ERAC protocol provides an evidence-based approach to reducing surgical complications, improving maternal outcomes and functional recovery, strengthening maternal-infant bonding, enhancing patient experience, and shortening hospital length of stay.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants in the control group will receive the standard perioperative nursing care routinely provided at the study site, including conventional preoperative, intraoperative, and postoperative practices without a structured protocol. • The intervention group will receive the Enhanced Recovery after Cesarean protocol of Care which consists of: Preoperative Care: * Patient education covering the procedure, perioperative expectations, pain management plan, early oral intake and mobilization goals, discharge criteria, and follow-up schedule. * Minimizing fasting: Solid food allowed up to 6 hours and clear fluids up to 2 hours prior to surgery. * Carbohydrate loading: Administration of 45g non-particulate carbohydrate drink up to 2 hours before surgery for non-diabetic mothers. Intraoperative Care: * Antibiotic prophylaxis: Administered within 60 minutes prior to skin incision. * Thermal regulation: Use of active warming methods, warmed IV fluids, and maintaining operating room temperatu
| Arm | Type | Receives |
|---|---|---|
| Experimental :ERAC arm (intervention) | Experimental | Procedure: Enhanced Recovery after Cesarean protocol of CareThe intervention group will receive the Enhanced Recovery After Cesarean (ERAC) protocol of care, consisting of the following components: Preoperative care: * Patient education. * Reduced preoperative fasting: solid food will be permitted until 6 hours before surgery, and clear fluids until 2 hours before surgery. * Preoperative carbohydrate loading. Intraoperative care: * Antibiotic prophylaxis. * Thermal regulation using active warming methods, warmed intravenous fluids, and maintenance of an appropriate operating room temperature. * Neuraxial anesthesia with strategies to prevent maternal hypotension. * Delayed cord clamping for 30-60 seconds after birth. * Immediate maternal-newborn bonding through skin-to-skin contact and early initiation of breastfeeding in the operating room, when clinically feasible. Postoperative care: • Prophylaxis for pos |
| Routine care arm | Active comparator | Procedure: Routine hospital careThe control group will receive routine nursing care only (pre-operative, intraoperative and postoperative).NPO for at least 8 hrs for food and fluid ,immediate cord clamping ,no mutlimodal analgesia ,catheter removal after at least 12 hrs |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women undergoing planned cesarean delivery.
- Scheduled to receive neuraxial anesthesia.
- Gestational age of 37 weeks or more.
- Singleton pregnancy.
Key exclusion criteria (2 listed)
- Women requiring additional interventions outside the Enhanced Recovery After Cesarean (ERAC) pathway, including severe coagulopathy or active infection.
- Women expected to require prolonged hospitalization because of a history of uterine rupture, pre-existing hypertension, pregnancy-induced hypertension, or placenta accreta.
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 Cesarean protocol of Care• The intervention group will receive the Enhanced Recovery after Cesarean protocol of Care which consists of: Preoperative Care: * Patient education covering the procedure, perioperative expectations, pain management plan, early oral intake and mobilization goals, discharge criteria, and follow-up schedule. * Minimizing fasting: Solid food allowed up to 6 hours and clear fluids up to 2 hours prior to surgery. * Carbohydrate loading: Administration of 45g non-particulate carbohydrate drink up to 2 hours before surgery for non-diabetic mothers. Intraoperative Care: * Antibiotic prophylaxis: Administered within 60 minutes prior to skin incision. * Thermal regulation: Use of active warming methods, warmed IV fluids, and maintaining operating room temperature >72.8°F (22.7°C). * Anesthesia: Neuraxial anesthesia with hypotension prevention strategies (fluid preloading/co-loading and phenylephrine infusion). * Delayed cord clamping: For 30-60 seconds after birth. * Immediate maternal-newborn | Procedure or surgery | Experimental :ERAC arm (intervention) |
| Routine hospital careThe control group will receive routine preoperative, intraoperative, and postoperative nursing care according to standard hospital practice. Preoperative care: • Fasting from both food and fluids for at least 8 hours before surgery. Intraoperative care: • Immediate umbilical cord clamping after birth. Postoperative care: * Analgesia according to routine hospital practice without a standardized multimodal analgesic regimen. * Urinary catheter removal at least 12 hours after surgery. | Procedure or surgery | Routine care arm |
Primary outcome
Maternal quality of recovery score
Time frame: at day 0 and 2 weeks postoperative
Maternal quality of recovery will be measured using a 40-item questionnaire. Each item is rated on a three-point Likert scale: 1 = rarely, 2 = sometimes, and 3 = always. Scores are reversed for negatively worded items. Total scores range from 40 to 120, with higher scores indicating better quality of recovery and lower scores indicating poorer quality of recovery.
9 secondary outcomes
Incidence of intraoperative hypotension
Time frame: day 0 of surgery
Incidence of intraoperative nausea and vomiting
Time frame: During cesarean delivery.
Time to first semisolid food intake
Time frame: From completion of surgery until first semisolid food intake during hospitalization.
Time to first ambulation
Time frame: From completion of surgery until first ambulation during hospitalization.
Hospital length of stay
Time frame: From completion of surgery until hospital discharge.
Hospital readmission
Time frame: Within 30 days after surgery.
Neonatal Outcome Measures
Time frame: At 1st and 5th minute after birth.
Neonatal intensive care unit admission
Time frame: From birth until hospital discharge.
Neonatal birth weight
Time frame: Immediately after birth.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the participants' informed consent and institutional ethical approval did not include external sharing of participant-level data. Aggregate study findings will be reported in scientific publications.
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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. This study is not recruiting at the moment.
Noura G El-Gamel, MSc principal investigator
Mansoura University
Enas S Fathy study chair
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Recovery after Cesarean protocol of Care and Routine hospital care in people with Cesarean Section, run by Mansoura University at 1 site in Egypt.
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 2 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: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal quality of recovery score (time frame: at day 0 and 2 weeks postoperative). 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 Jul 2026.