Malnutrition in PregnancyNCT06164301
Value of Early Postoperative Peptide-based Formula in Critically Ill Obstetrics on Recovery Enhancement
A study testing Elemental amino-acids in people with Malnutrition in Pregnancy and Malnutrition; Protein, run by Ain Shams University at 1 site in Egypt.
Trial summary
This is the first trial to assess the early semi-elemental postoperative formula load to meet the protein requirements in the first and second day postoperative to enhance the recovery of critically ill parturient (value on ERAS of critically ill obstetrics) Read more about this study
- Who is it for?
- Ages 16 to 50 years, women only
- Conditions the study is for
- Malnutrition in Pregnancy, Malnutrition; Protein, Postpartum Disorder
- What is being tested?
- Elemental amino-acids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Apr 2024to 1 Mar 2026
- 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 16 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Critically ill Female patients with cesarean section with or without hysterectomy that requires ICU admission pre or postoperative
Who cannot join
- Decompensated heart failure,
- Known allergy
- Tryptophan intolerance
- known inborn errors of metabolism of proteins as alkaptonuria
- severe hepatic dysfunction (failure)
- severe renal dysfunction (failure)
Show all 10Show fewer
- severe coagulopathy or DIC
- circulatory shock or hemodynamic instability
- Lactose intolerance
- G6PD deficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Value of Early Postoperative Peptide-based, Semi-elemental Enteral Formulation in Critically Ill Obstetric Patients Within an ERAS Framework: a Pragmatic Randomized Controlled Trial
This is the first trial to assess the early semi-elemental postoperative formula load to meet the protein requirements in the first and second day postoperative to enhance the recovery of critically ill parturient (value on ERAS of critically ill obstetrics)
Read the detailed description
The objective is to measure the effect of peptide-based semi-elemental formula in the early post-operative period on reaching protein adequacy as well as energy intakes, gut function, clinical outcomes, and the quality of recovery.
All candidates will be assessed thoroughly by history and examination, and informed consent will be taken. All patients will be admitted to the obstetrics ICU. where degree of severity of the condition will be assessed and the relevant protocol of treatment will be started. All patients will receive the treatment algorithm of critically ill as follow; Prophylactic anticoagulation (Enoxaparin 40 mg once daily) when appropriate after surgeon consultation. Antibiotic as policy, Proton pump inhibitors (omeprazole 40 mg once daily), Other supportive medication according to the needs of the condition, For postoperative pain routine care in the form of use of paracetamol (10mg/kg/8 hrs), and non-steroidal anti-inflammatory(ketorolac 30 mg /12 hrs ) medication and nalbuphine will be used till comfort of the patient. All doses will be adjusted according to body weight and organ function when required. Base line laboratory indices will be withdrawn including; CBC, Metabolic profile, liver function profile, renal function profile, ABG, INR.
The eligible patients will be randomly assigned into one of two groups through the random numbers, the random numbers will be used by a pharmacist who will prepare the different regimen. the data collector will be blind about the grouping intervention. A)intervention group ; post-operative within the first 3 hours the patient will receive 250 ml of peptide-based, semi-elemental protein( 250 ml Peptamen = 6 scoops (55g) + 210ml water ) repeated at ( 6, 8 , 10 , 12 hours postoperative ) in order to reach total protein in order to reach total protein 50 mg in the first 12 hour post-operative, Second day ordinary food will be introduced supplemented by half the dose of the first day from elemental protein (250 ml / 6 hours ) or to the dose to achieve the daily protein adequacy 1.3 mg/kg/day. B) Standard group; The patients in this group will receive the standard protocol in which they will be made NPO till the return of bowel functions. Thereafter, water and clear fluids will be given followed by soft food and, eventually a regular diet. Protein requirement in postpartum around 1g/kg reaching up to 1.9 gm/kg 11. The investigator will standardize the intake to 1.3g/kg.
In both groups intravenous fluid will be given according to hemodynamic in the form of ringer acetate with basal infusion 40ml/hr and will be adjusted according to hemodynamic parameters. In both groups, daily food and fluid record will be assessed by research assistant who will follow both the patient recall and the nurse record. The research assistant will be provided by written details in how to calculate protein and energy intake.
- Conditions
- Malnutrition in Pregnancy, Malnutrition; Protein, Postpartum Disorder, Patient Satisfaction, Critical Illness
- Being tested
- Elemental amino-acids
- Keywords
- critical illness, nutrition therapy, Enhanced Recovery After Surgery, Enhanced Recovery After Caesarean section
- Medical subject headings
- Kwashiorkor, Puerperal Disorders, Patient Satisfaction, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elemental amino-acidsDietary supplement
mono peptide oral protein formula
| Study group | Role | What they receive |
|---|---|---|
| peptide-based semi-elemental formula group | Experimental | peptide-based, semi-elemental group ; post-operative within the first 3 hours the patient will receive 250 ml of semi-elemental protein( 250 ml Peptamen = 6 scoops (55g) + 210ml water ) repeated at ( 6, 8 , 10 , 12 hours postoperative ) in order to reach total protein in order to reach total protein 50 mg in the first 12 hour post-operative, Second day ordinary food will be introduced supplemented by half the dose of the first day from semi-elemental protein (250 ml / 6 hours ) or to the dose to achieve the daily protein adequacy 1.3 mg/kg/day. Receives: Dietary Supplement: Elemental amino-acids |
| standard | Active comparator | Standard group; The patients in this group will receive the standard protocol in which they will be made NPO till the return of bowel functions. Thereafter, water and clear fluids will be given followed by soft food and, eventually a regular diet. Receives: Dietary Supplement: Elemental amino-acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
the protein intake
total protein intake/day measurement tool is calculation based on protein content in the food intake list , and measured by gram/kg/day
Measured: 24 hours postoperative. If the patient stay extended more than a day, the intake of second 24 hours will be calculated,
The energy intake
total energy intake/day, The measurement tool is calculated by an experienced clinical nutrition pharmacist based on food and supplements intake in nursing records and patient recall, and measured by kcal/kg/day
Measured: 24 hours postoperative. If the patient stay extended more than a day, the intake of second 24 hours will be calculated
Secondary outcomes (1)
satisfaction and Patient reported outcome measures (PROMs) regarding recovery aspects (physical comfort- emotional state, physical independence and pain
will be assessed using the Obstetric Quality of Recovery-10A survey tool and measured by units on the scale, it is 10 questions with answers on a scale from 0 to 10 where 0 =very poor and 10 = excellent. with cumulative score where <71= poor, 71-88= moderate, >88= excellent.
Measured: After 48 hours or at discharge from ICU which comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start14 Apr 2024
- Primary completion20 Jan 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Malnutrition in PregnancyStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be assigned into either; A)intervention group; post-operative within the first 3 hours the patient will receive 250 ml of semi-elemental protein( 250 ml Peptamen = 6 scoops (55g) + 210ml water ) repeated at ( 6, 8 , 10 , 12 hours postoperative ) , Second day ordinary food will be supplemented by half the dose of the first day from the semi-elemental protein (250 ml / 6 hours ) or to the dose to achieve the daily protein adequacy 1.3 mg/kg/day. B) The standard group will be NPO till the return of bowel functions.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- wessam selima, MD, Principal investigator, assistant professor (lecturer)- Ain shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164301
- Sponsor's protocol ID
- FMASU R290/2023
- Status last verified
- Mar 2026
- First submitted
- 21 Nov 2023
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be shared on reasonable request
Publications
Macones GA, Caughey AB, Wood SL, Wrench IJ, Huang J, Norman M, Pettersson K, Fawcett WJ, Shalabi MM, Metcalfe A, Gramlich L, Nelson G, Wilson RD. Guidelines for postoperative care in cesarean delivery: Enhanced Recovery After Surgery (ERAS) Society recommendations (part 3). Am J Obstet Gynecol. 2019 Sep;221(3):247.e1-247.e9. doi: 10.1016/j.ajog.2019.04.012. Epub 2019 Apr 14.
PubMed 30995461Looijaard WGPM, Denneman N, Broens B, Girbes ARJ, Weijs PJM, Oudemans-van Straaten HM. Achieving protein targets without energy overfeeding in critically ill patients: A prospective feasibility study. Clin Nutr. 2019 Dec;38(6):2623-2631. doi: 10.1016/j.clnu.2018.11.012. Epub 2018 Dec 17.
PubMed 30595377Meyer R, Foong RX, Thapar N, Kritas S, Shah N. Systematic review of the impact of feed protein type and degree of hydrolysis on gastric emptying in children. BMC Gastroenterol. 2015 Oct 15;15:137. doi: 10.1186/s12876-015-0369-0.
PubMed 26472544
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Early Postoperative Peptide-based, Semi-elemental Enteral Formulation in Critically Ill Obstetric Patients Within an ERAS Framework: a Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06164301
- Acronym / sponsor ID
- FMASU R290/2023
- Conditions
- Malnutrition in Pregnancy, Malnutrition; Protein, Postpartum Disorder, Patient Satisfaction, Critical Illness
- Keywords
- critical illness, nutrition therapy, Enhanced Recovery After Surgery, Enhanced Recovery After Caesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 14 Apr 2024 (actual)
- Primary completion
- 20 Jan 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 11 Dec 2023 (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 is the first trial to assess the early semi-elemental postoperative formula load to meet the protein requirements in the first and second day postoperative to enhance the recovery of critically ill parturient (value on ERAS of critically ill obstetrics)
Detailed description
The objective is to measure the effect of peptide-based semi-elemental formula in the early post-operative period on reaching protein adequacy as well as energy intakes, gut function, clinical outcomes, and the quality of recovery.
All candidates will be assessed thoroughly by history and examination, and informed consent will be taken. All patients will be admitted to the obstetrics ICU. where degree of severity of the condition will be assessed and the relevant protocol of treatment will be started. All patients will receive the treatment algorithm of critically ill as follow; Prophylactic anticoagulation (Enoxaparin 40 mg once daily) when appropriate after surgeon consultation. Antibiotic as policy, Proton pump inhibitors (omeprazole 40 mg once daily), Other supportive medication according to the needs of the condition, For postoperative pain routine care in the form of use of paracetamol (10mg/kg/8 hrs), and non-steroidal anti-inflammatory(ketorolac 30 mg /12 hrs ) medication and nalbuphine will be used till comfort of the patient. All doses will be adjusted according to body weight and organ function when required. Base line laboratory indices will be withdrawn including; CBC, Metabolic profile, liver function profile, renal function profile, ABG, INR.
The eligible patients will be randomly assigned into one of two groups through the random numbers, the random numbers will be used by a pharmacist who will prepare the different regimen. the data collector will be blind about the grouping intervention. A)intervention group ; post-operative within the first 3 hours the patient will receive 250 ml of peptide-based, semi-elemental protein( 250 ml Peptamen = 6 scoops (55g) + 210ml water ) repeated at ( 6, 8 , 10 , 12 hours postoperative ) in order to reach total protein in order to reach total protein 50 mg in the first 12 hour post-operative, Second day ordinary food will be introduced supplemented by half the dose of the first day from elemental protein (250 ml / 6 hours ) or to the dose to achieve the daily protein adequacy 1.3 mg/kg/day. B) Standard group; The patients in this group will receive the standard protocol in which they will be made NPO till the return of bowel functions. Thereafter, water and clear fluids will be given followed by soft food and, eventually a regular diet. Protein requirement in postpartum around 1g/kg reaching up to 1.9 gm/kg 11. The investigator will standardize the intake to 1.3g/kg.
In both groups intravenous fluid will be given according to hemodynamic in the form of ringer acetate with basal infusion 40ml/hr and will be adjusted according to hemodynamic parameters. In both groups, daily food and fluid record will be assessed by research assistant who will follow both the patient recall and the nurse record. The research assistant will be provided by written details in how to calculate protein and energy intake.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be assigned into either; A)intervention group; post-operative within the first 3 hours the patient will receive 250 ml of semi-elemental protein( 250 ml Peptamen = 6 scoops (55g) + 210ml water ) repeated at ( 6, 8 , 10 , 12 hours postoperative ) , Second day ordinary food will be supplemented by half the dose of the first day from the semi-elemental protein (250 ml / 6 hours ) or to the dose to achieve the daily protein adequacy 1.3 mg/kg/day. B) The standard group will be NPO till the return of bowel functions.
| Arm | Type | Receives |
|---|---|---|
| peptide-based semi-elemental formula group | Experimental | Dietary Supplement: Elemental amino-acidspeptide-based, semi-elemental group ; post-operative within the first 3 hours the patient will receive 250 ml of semi-elemental protein( 250 ml Peptamen = 6 scoops (55g) + 210ml water ) repeated at ( 6, 8 , 10 , 12 hours postoperative ) in order to reach total protein in order to reach total protein 50 mg in the first 12 hour post-operative, Second day ordinary food will be introduced supplemented by half the dose of the first day from semi-elemental protein (250 ml / 6 hours ) or to the dose to achieve the daily protein adequacy 1.3 mg/kg/day. |
| standard | Active comparator | Dietary Supplement: Elemental amino-acidsStandard group; The patients in this group will receive the standard protocol in which they will be made NPO till the return of bowel functions. Thereafter, water and clear fluids will be given followed by soft food and, eventually a regular diet. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Critically ill Female patients with cesarean section with or without hysterectomy that requires ICU admission pre or postoperative
Key exclusion criteria (10 listed)
- Decompensated heart failure,
- Known allergy
- Tryptophan intolerance
- known inborn errors of metabolism of proteins as alkaptonuria
- severe hepatic dysfunction (failure)
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 |
|---|---|---|
| Elemental amino-acidsmono peptide oral protein formula | Dietary supplement | peptide-based semi-elemental formula group, standard |
Primary outcome
the protein intake
Time frame: 24 hours postoperative. If the patient stay extended more than a day, the intake of second 24 hours will be calculated,
total protein intake/day measurement tool is calculation based on protein content in the food intake list , and measured by gram/kg/day
The energy intake
Time frame: 24 hours postoperative. If the patient stay extended more than a day, the intake of second 24 hours will be calculated
total energy intake/day, The measurement tool is calculated by an experienced clinical nutrition pharmacist based on food and supplements intake in nursing records and patient recall, and measured by kcal/kg/day
1 secondary outcome
satisfaction and Patient reported outcome measures (PROMs) regarding recovery aspects (physical comfort- emotional state, physical independence and pain
Time frame: After 48 hours or at discharge from ICU which comes first
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 11 Mar 2026.
- Background: PubMed 30995461Macones GA, Caughey AB, Wood SL, Wrench IJ, Huang J, Norman M, Pettersson K, Fawcett WJ, Shalabi MM, Metcalfe A, Gramlich L, Nelson G, Wilson RD. Guidelines for postoperative care in cesarean delivery: Enhanced Recovery After Surgery (ERAS) Society recommendations (part 3). Am J Obstet Gynecol. 2019 Sep;221(3):247.e1-247.e9. doi: 10.1016/j.ajog.2019.04.012. Epub 2019 Apr 14.
- Background: PubMed 30595377Looijaard WGPM, Denneman N, Broens B, Girbes ARJ, Weijs PJM, Oudemans-van Straaten HM. Achieving protein targets without energy overfeeding in critically ill patients: A prospective feasibility study. Clin Nutr. 2019 Dec;38(6):2623-2631. doi: 10.1016/j.clnu.2018.11.012. Epub 2018 Dec 17.
- Background: PubMed 26472544Meyer R, Foong RX, Thapar N, Kritas S, Shah N. Systematic review of the impact of feed protein type and degree of hydrolysis on gastric emptying in children. BMC Gastroenterol. 2015 Oct 15;15:137. doi: 10.1186/s12876-015-0369-0.
- Individual participant dataSharing planned: Yes. Deidentified data will be shared on reasonable request
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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.
wessam selima, MD principal investigator
assistant professor (lecturer)- Ain shams 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 Elemental amino-acids in people with Malnutrition in Pregnancy and Malnutrition; Protein, run by Ain Shams 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 1 inclusion and 10 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 11 Mar 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?
the protein intake (time frame: 24 hours postoperative. If the patient stay extended more than a day, the intake of second 24 hours will be calculated,). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06164301, which also lists 3 linked publications.
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 11 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.