Breastfeeding Evaluation of Puerperal Women Who Had Cesarean Delivery in Our Hospital

NCT06682871 | Completed DMC

• 1 other identifier: 2024/4806
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

İntroduction The World Health Organisation (WHO) and United Nations Children's Fund (UNICEF) recommends that infants are exclusively breastfed for a minimum of 6 months, with continued breastfeeding recommended until child age of 2 years or over to optimize growth, development, and health. Breast milk shows significant benefits for the physical and mental health of mothers and infants, including the promotion of maternal and infant bonding, the reduction of neonatal mortality, the reduction of maternal postoperative complications, and the development of newborns. Breastfeeding has been associated with improved maternal/infant bonding and increased child intelligence. It is also clear that medical interventions during labor and birth, including a caesarean section, impact on women's infant feeding decisions and are a cause for concern given increasing global caesarean birth rates, with woman who have a planned caesarean birth reported as less likely to intend to breastfeed than women who did not have a planned caesarean birth or had a vaginal birth. Infrequent feeding and women's limited mobility in the early days following surgery may impede efforts to provide basic infant care. High levels of postoperative pain, particularly in the first 24 hrs, were also found to have a negative impact on women's breastfeeding experiences. Cesarean delivery is linked with lower rates of early breastfeeding initiation. Pain management after casarean delivery remains challenging. The best-accepted traditional analgesic approach is continuous epidural analgesia. However, epidural analgesia is rapidly being replaced by transversus abdominis plane (TAP) blocks. TAP infiltration is an alternative to epidural blocks for providing postoperative analgesia to the anterior abdominal wall. TAP infiltrations are relatively easy to perform, generally safe, and can be performed in patients who are anti-coagulated. TAP infiltration can be performed as a single injection, or a catheter can be inserted for continuous local anesthetic infusion.

Conditions

Breast Feeding; Analgesia

Keywords

Post-cesarean analgesia; Breastfeeding; latch score; visuel pain score

Outcome Measures

Primary Outcomes (1)

• To compare the effect of pain management after cesarean on the rates of initiation of breastfeeding

  Four quadrant TAP blocks performed after elective inert cesarean section increase the rate of breastfeeding in the first 1 hour and the rate of exclusive breastfeeding in the first 72 hours.

  1 year

Study Arms (3)

Arm T: Transversus Abdominis Plane (TAP) blocks with bupivacaine

ACTIVE COMPARATOR

Infants of mothers who received 4-Quadrant TAP block after inactive elective spinal cesarean section (25 patients)

Procedure: Analgesia

Arm E : Epidural Analgesia with bupivacaine

ACTIVE COMPARATOR

Infants of mothers who received Epidural analgesia after inactive elective spinal cesarean section (25 patients)

Procedure: Analgesia

Arm M: Iv Multimodal Analgesia with paracetamol or tramadol

ACTIVE COMPARATOR

Infants of mothers who received Multimodal intravenous analgesia after inactive elective spinal cesarean section (25 patients)

Procedure: Analgesia

Interventions

Analgesia PROCEDURE

Postoperatively, patients will be given analgesia

Arm E : Epidural Analgesia with bupivacaine; Arm M: Iv Multimodal Analgesia with paracetamol or tramadol; Arm T: Transversus Abdominis Plane (TAP) blocks with bupivacaine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent;
• years old;
• ASA Physical Status 1-3;
• Scheduled for elective cesarien delivery;
• Anticipated hospitalization of at least three nights;
• Expected requirement for parenteral opioids for at least 72 hours for postoperative pain;
• Able to use IV PCA systems.

You may not qualify if:

• Hepatic disease, e.g. twice the normal levels of liver enzymes;
• Kidney disease, e.g. twice the normal level of serum creatinine;
• Bupivacaine sensitivity or known allergy;
• Anticoagulants considered to be a contraindication for TAP blocks;
• Surgeries with high port sites

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Konya City Hospital

Konya, 42080, Turkey (Türkiye)

Location

Related Publications (1)

• MacGregor E, Hughes M. Breastfeeding experiences of mothers from disadvantaged groups: a review. Community Pract. 2010 Jul;83(7):30-3.

  PMID: 20701189 RESULT

Related Links

• PUBMED

MeSH Terms

Conditions

Breast Feeding; Agnosia

Interventions

Analgesia

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• Ramazan Keçeci, Specialist

  Konya City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization will be based on computer-generated codes and use random-sized blocks. Allocations will be concealed until the morning of surgery where they will be provided by a web-based system
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: NEONATOLOGIST, MD, PRINCIPAL INVESTIGATOR

Model Details: D. Protocol After eligibility is confirmed, patients will receive complete information about the study both verbally and in writing. Informed consent will be obtained from the patients prior to randomization and study-specific procedures. Randomization will be based on computer-generated codes and use random-sized blocks. Allocations will be concealed until the morning of surgery where they will be provided by a web-based system.

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: November 12, 2024
• Study Start: January 1, 2024
• Primary Completion: July 23, 2025
• Study Completion: July 25, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 year
• Access Criteria: No Criteria

Locations

TU (1)