Cesarean BirthPhase 3NCT07502235
The Effect of Lactoferrin on Pain Management Following Cesarean Section
A Phase 3 study testing Lactoferrin in people with Cesarean Birth and Post Operative Analgesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study evaluates whether lactoferrin, a naturally occurring protein with anti-inflammatory and antioxidant properties, can improve pain control after cesarean section. Effective management of postoperative pain is essential to support maternal recovery, mobility, and the ability to care for the newborn, while… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cesarean Birth, Post Operative Analgesia
- What is being tested?
- Lactoferrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Mar 2026to 26 Sep 2026
- Phase
- Phase 3
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Referred to elective (non-emergency) cesarean section
- Undergoing spinal anesthesia) with American Society of Anesthesiologists (ASA) classification I and II
- Term gestational age
Who cannot join
- History of seizures
- Pre-eclampsia or eclampsia
- Hypertension
- Use of narcotic painkillers for 24 h before the intervention
- Medications inducing neuropathy including Amiodarone, Metronidazole, Phenytoin \& Colchicine.
- Prolongation of cesarean section (more than 1.5 h)
Show all 11Show fewer
- Increase in the size of the incision
- Occurrence of any unusual complication during surgery,
- Failure of spinal anesthesia and its conversion to general anesthesia
- Contraindications to spinal anesthesia
- Use of interacting medication: fluoroquinolones, loratadine, fexofenadine, alvimopan, armodafinil
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Mansoura Hospital
Cairo, 11856
Khaled Samir Associate Professor of gynecology, MD, +201097452797, khalid_samir@mans.edu.eg
About this study
This study evaluates whether lactoferrin, a naturally occurring protein with anti-inflammatory and antioxidant properties, can improve pain control after cesarean section. Effective management of postoperative pain is essential to support maternal recovery, mobility, and the ability to care for the newborn, while minimizing reliance on opioid medications and their associated side effects.
In this randomized, double-blind, placebo-controlled trial, women undergoing elective cesarean section will receive either oral lactoferrin or a matching placebo in addition to standard postoperative analgesia. Lactoferrin will be administered starting before surgery and continued for 48 hours after delivery.
The study will assess whether lactoferrin reduces postoperative pain intensity and opioid consumption, and improves recovery outcomes such as time to mobilization, patient satisfaction, and incidence of common postoperative symptoms. Safety and tolerability will also be evaluated.
Read the detailed description
Cesarean section is one of the most commonly performed surgical procedures worldwide, and optimal postoperative pain control remains a clinical priority. Inadequate pain management can delay recovery, impair maternal-infant interaction, prolong hospitalization, and increase the risk of complications such as thromboembolism. Although opioids are effective for postoperative analgesia, their use is limited by dose-dependent adverse effects, prompting the need for adjunctive therapies that enhance analgesia while reducing opioid requirements.
Lactoferrin is a naturally occurring iron-binding glycoprotein present in breast milk and other body secretions, with well-documented anti-inflammatory, antioxidant, and immunomodulatory properties. Experimental and clinical evidence suggests that lactoferrin modulates key inflammatory mediators involved in pain signaling, including pro-inflammatory cytokines, and may exert antinociceptive effects through both peripheral and central mechanisms. These properties support its potential role as an adjunct in postoperative pain management; however, its efficacy in this setting has not been evaluated in a randomized clinical trial.
This study is designed as a prospective, randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of lactoferrin on postoperative pain following elective cesarean section. Eligible participants will be randomized in a 1:1 ratio to receive either oral lactoferrin (250 mg twice daily) or a matching placebo. The first dose will be administered one hour prior to surgery, followed by continued dosing every 12 hours for 48 hours postoperatively. All participants will receive standardized spinal anesthesia and routine perioperative and postoperative analgesic care.
The primary objective is to assess the effect of lactoferrin on postoperative pain intensity, measured using a visual analog scale at predefined time points within the first 24 hours after surgery. Secondary objectives include evaluation of opioid consumption, time to first request for rescue analgesia, incidence of postoperative nausea and vomiting, other postoperative symptoms, time to mobilization, functional recovery, patient satisfaction, and hospital length of stay.
Safety will be assessed through monitoring of adverse events, including gastrointestinal symptoms, allergic reactions, and other treatment-related effects. All adverse events will be documented and evaluated for severity and causality.
The sample size has been calculated to provide adequate statistical power to detect clinically meaningful differences in primary and secondary outcomes between groups. Statistical analyses will be conducted using an intention-to-treat approach with appropriate methods for continuous and categorical variables.
This trial aims to provide clinical evidence on the potential role of lactoferrin as a safe and effective adjunct to standard analgesic regimens for improving postoperative pain control and recovery following cesarean section.
- Conditions
- Cesarean Birth, Post Operative Analgesia
- Being tested
- Lactoferrin, Placebo
- Keywords
- post operative pain, lactoferrin, analgesia, pain management, obstetric surgery, post operative analgesia
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactoferrinDrug
Lactoferrin 250 mg orally twice daily (BID). The first dose will be given 1 hour preoperatively, followed by repeat doses every 12 hours for 48 hours postoperatively
PlaceboOther
matching placebo capsules administered on the same schedule as the lactoferrin group (first dose 1 hour preoperatively, then every 12 hours for 48 hours).
| Study group | Role | What they receive |
|---|---|---|
| Lactoferrin | Experimental | Lactoferrin 250 mg orally twice daily (BID). The first dose will be given 1 hour preoperatively, followed by repeat doses every 12 hours for 48 hours postoperatively Receives: Drug: Lactoferrin |
| Placebo | Placebo comparator | will receive matching placebo capsules administered on the same schedule as the lactoferrin group (first dose 1 hour preoperatively, then every 12 hours for 48 hours). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity ( 2 hours)
Pain intensity using 10 cm Visual analogue scale (VAS)
Measured: 2 hours
Pain intensity (6 hours)
pain intensity using 10 cm visual analogue scale (VAS)
Measured: 6 hours
Pain intensity (12 hours)
pain intensity using 10 cm visual analogue scale (VAS)
Measured: 12 hours
Pain intensity (24 hours)
pain intensity using 10 cm visual analogue scale (VAS)
Measured: 24 hours
Secondary outcomes (6)
nausea and vomiting ( 2 hours)
severity of nausea/ vomiting (n/v) using a numerical scale from 0 to 2 (0=no nausea, 1= mild n/v, and 2= severe n/v)
Measured: 2 hours
nausea and vomiting (6 hours)
severity of nausea/ vomiting (n/v) using a numerical scale from 0 to 2 (0=no nausea, 1= mild n/v, and 2= severe n/v)
Measured: 6 hours
nausea and vomiting (12 hours)
severity of nausea/ vomiting (n/v) using a numerical scale from 0 to 2 (0=no nausea, 1= mild n/v, and 2= severe n/v)
Measured: 12 hours
nausea and vomiting (24 hours)
severity of nausea/ vomiting (n/v) using a numerical scale from 0 to 2 (0=no nausea, 1= mild n/v, and 2= severe n/v)
Measured: 24 hours
Rescue analgesia
The patient's first request for post operative analgesia
Measured: 24 hours
opioid intake
the patient's opioid intake in the 24 hours after surgery
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start26 Mar 2026 (estimated)
- Primary completion26 Aug 2026 (estimated)
- Study completion26 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean BirthStudies 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mohamed El Mokadem, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502235
- Sponsor's protocol ID
- REC-FPFUE_NO 6/2026
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mohamed Elmokadem E, Khaled Abou El Fadl D, Bassiouny AM, Mahmoud MMAE, Samy M, El Said NO. The Adjunctive Effect of Quercetin on Postoperative Pain Management Following Cesarean Section: A Randomized Controlled Study. Drug Des Devel Ther. 2025 Jul 14;19:6009-6024. doi: 10.2147/DDDT.S526188. eCollection 2025.
PubMed 40687903
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lactoferrin on Pain Management Following Cesarean Section
- ClinicalTrials.gov ID
- NCT07502235
- Acronym / sponsor ID
- REC-FPFUE_NO 6/2026
- Conditions
- Cesarean Birth, Post Operative Analgesia
- Keywords
- post operative pain, lactoferrin, analgesia, pain management, obstetric surgery, post operative analgesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 26 Mar 2026 (estimated)
- Primary completion
- 26 Aug 2026 (estimated)
- Study completion
- 26 Sep 2026 (estimated)
- First posted
- 30 Mar 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 evaluates whether lactoferrin, a naturally occurring protein with anti-inflammatory and antioxidant properties, can improve pain control after cesarean section. Effective management of postoperative pain is essential to support maternal recovery, mobility, and the ability to care for the newborn, while minimizing reliance on opioid medications and their associated side effects.
In this randomized, double-blind, placebo-controlled trial, women undergoing elective cesarean section will receive either oral lactoferrin or a matching placebo in addition to standard postoperative analgesia. Lactoferrin will be administered starting before surgery and continued for 48 hours after delivery.
The study will assess whether lactoferrin reduces postoperative pain intensity and opioid consumption, and improves recovery outcomes such as time to mobilization, patient satisfaction, and incidence of common postoperative symptoms. Safety and tolerability will also be evaluated.
Detailed description
Cesarean section is one of the most commonly performed surgical procedures worldwide, and optimal postoperative pain control remains a clinical priority. Inadequate pain management can delay recovery, impair maternal-infant interaction, prolong hospitalization, and increase the risk of complications such as thromboembolism. Although opioids are effective for postoperative analgesia, their use is limited by dose-dependent adverse effects, prompting the need for adjunctive therapies that enhance analgesia while reducing opioid requirements.
Lactoferrin is a naturally occurring iron-binding glycoprotein present in breast milk and other body secretions, with well-documented anti-inflammatory, antioxidant, and immunomodulatory properties. Experimental and clinical evidence suggests that lactoferrin modulates key inflammatory mediators involved in pain signaling, including pro-inflammatory cytokines, and may exert antinociceptive effects through both peripheral and central mechanisms. These properties support its potential role as an adjunct in postoperative pain management; however, its efficacy in this setting has not been evaluated in a randomized clinical trial.
This study is designed as a prospective, randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of lactoferrin on postoperative pain following elective cesarean section. Eligible participants will be randomized in a 1:1 ratio to receive either oral lactoferrin (250 mg twice daily) or a matching placebo. The first dose will be administered one hour prior to surgery, followed by continued dosing every 12 hours for 48 hours postoperatively. All participants will receive standardized spinal anesthesia and routine perioperative and postoperative analgesic care.
The primary objective is to assess the effect of lactoferrin on postoperative pain intensity, measured using a visual analog scale at predefined time points within the first 24 hours after surgery. Secondary objectives include evaluation of opioid consumption, time to first request for rescue analgesia, incidence of postoperative nausea and vomiting, other postoperative symptoms, time to mobilization, functional recovery, patient satisfaction, and hospital length of stay.
Safety will be assessed through monitoring of adverse events, including gastrointestinal symptoms, allergic reactions, and other treatment-related effects. All adverse events will be documented and evaluated for severity and causality.
The sample size has been calculated to provide adequate statistical power to detect clinically meaningful differences in primary and secondary outcomes between groups. Statistical analyses will be conducted using an intention-to-treat approach with appropriate methods for continuous and categorical variables.
This trial aims to provide clinical evidence on the potential role of lactoferrin as a safe and effective adjunct to standard analgesic regimens for improving postoperative pain control and recovery following cesarean section.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactoferrin | Experimental | Drug: LactoferrinLactoferrin 250 mg orally twice daily (BID). The first dose will be given 1 hour preoperatively, followed by repeat doses every 12 hours for 48 hours postoperatively |
| Placebo | Placebo comparator | Other: Placebowill receive matching placebo capsules administered on the same schedule as the lactoferrin group (first dose 1 hour preoperatively, then every 12 hours for 48 hours). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Referred to elective (non-emergency) cesarean section
- Undergoing spinal anesthesia) with American Society of Anesthesiologists (ASA) classification I and II
- Term gestational age
Key exclusion criteria (11 listed)
- History of seizures
- Pre-eclampsia or eclampsia
- Hypertension
- Use of narcotic painkillers for 24 h before the intervention
- Medications inducing neuropathy including Amiodarone, Metronidazole, Phenytoin \& Colchicine.
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 |
|---|---|---|
| LactoferrinLactoferrin 250 mg orally twice daily (BID). The first dose will be given 1 hour preoperatively, followed by repeat doses every 12 hours for 48 hours postoperatively | Drug | Lactoferrin |
| Placebomatching placebo capsules administered on the same schedule as the lactoferrin group (first dose 1 hour preoperatively, then every 12 hours for 48 hours). | Other | Placebo |
Primary outcome
Pain intensity ( 2 hours)
Time frame: 2 hours
Pain intensity using 10 cm Visual analogue scale (VAS)
Pain intensity (6 hours)
Time frame: 6 hours
pain intensity using 10 cm visual analogue scale (VAS)
Pain intensity (12 hours)
Time frame: 12 hours
pain intensity using 10 cm visual analogue scale (VAS)
Pain intensity (24 hours)
Time frame: 24 hours
pain intensity using 10 cm visual analogue scale (VAS)
6 secondary outcomes
nausea and vomiting ( 2 hours)
Time frame: 2 hours
nausea and vomiting (6 hours)
Time frame: 6 hours
nausea and vomiting (12 hours)
Time frame: 12 hours
nausea and vomiting (24 hours)
Time frame: 24 hours
Rescue analgesia
Time frame: 24 hours
opioid intake
Time frame: 24 hours
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 30 Mar 2026.
- Background: PubMed 40687903Mohamed Elmokadem E, Khaled Abou El Fadl D, Bassiouny AM, Mahmoud MMAE, Samy M, El Said NO. The Adjunctive Effect of Quercetin on Postoperative Pain Management Following Cesarean Section: A Randomized Controlled Study. Drug Des Devel Ther. 2025 Jul 14;19:6009-6024. doi: 10.2147/DDDT.S526188. eCollection 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lactoferrin in people with Cesarean Birth and Post Operative Analgesia, 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 3 inclusion and 11 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 30 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity ( 2 hours) (time frame: 2 hours). The study lists 4 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 NCT07502235, which also lists 1 linked publication.
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 30 Mar 2026.