beta
Trial Radar AI
Clinical Trial NCT07502235 for Cesarean Birth, Post Operative Analgesia is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

The Effect of Lactoferrin on Pain Management Following Cesarean Section Phase 3 90 Randomized Double-Blind Placebo-Controlled

Not yet recruiting
Clinical Trial NCT07502235 is designed to study Supportive Care for Cesarean Birth, Post Operative Analgesia. This Phase 3 interventional study is not yet recruiting. Enrollment is planned to begin on March 26, 2026 until the study accrues 90 participants. Led by Ain Shams University, this study is expected to complete by September 26, 2026. The latest data from ClinicalTrials.gov was last updated on March 30, 2026.
Brief 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 minimizing reliance on opioid medications and their associated side effects.

In this randomized, double-...

Show More
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-depen...Show More
Official Title

The Effect of Lactoferrin on Pain Management Following Cesarean Section

Conditions
Cesarean BirthPost Operative Analgesia
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • REC-FPFUE_NO 6/2026
NCT ID Number
NCT07502235
Start Date (Actual)
2026-03-26
Last Update Posted
2026-03-30
Completion Date (Estimated)
2026-09-26
Enrollment (Estimated)
90
Study Type
Interventional
PHASE
Phase 3
Status
Not yet recruiting
Keywords
post operative pain
lactoferrin
analgesia
pain management
obstetric surgery
post operative analgesia
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalLactoferrin
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
Lactoferrin
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
Placebo ComparatorPlacebo
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).
Placebo
matching placebo capsules administered on the same schedule as the lactoferrin group (first dose 1 hour preoperatively, then every 12 hours for 48 hours).
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Pain intensity ( 2 hours)
Pain intensity using 10 cm Visual analogue scale (VAS)
2 hours
Pain intensity (6 hours)
pain intensity using 10 cm visual analogue scale (VAS)
6 hours
Pain intensity (12 hours)
pain intensity using 10 cm visual analogue scale (VAS)
12 hours
Pain intensity (24 hours)
pain intensity using 10 cm visual analogue scale (VAS)
24 hours
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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)
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)
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)
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)
24 hours
Rescue analgesia
The patient's first request for post operative analgesia
24 hours
opioid intake
the patient's opioid intake in the 24 hours after surgery
24 hours
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
  • Referred to elective (non-emergency) cesarean section
  • Undergoing spinal anesthesia) with American Society of Anesthesiologists (ASA) classification I and II
  • Term gestational age

  • 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)
  • 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
Ain Shams University logoAin Shams University344 active studies to explore
Study Responsible Party
Eman Mohamed El Mokadem, Principal Investigator, Lecturer of Pharmacy Practice and Clinical Pharmacy, Ain Shams University
No contact data.
1 Study Locations in 1 Countries
Mansoura Hospital, Cairo, 11856, Egypt
Khaled Samir Associate Professor of gynecology, MD, Contact, +201097452797, [email protected]