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CompletedNCT06682871Updated Sep 3, 2025

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

An interventional study of Analgesia in Breast Feeding and Analgesia, sponsored by Konya City Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-03.

Sponsored by Konya City Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jan 2024, registered Oct 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

Read the detailed description

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. In addition breastfeeding has many benefits for infant, mother and later child health.

The World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) recommend initiation of breastfeeding within the first hour of birth, referred to as "early initiation of breastfeeding." Early initiation of breastfeeding is critical to newborn survival and to establish breastfeeding practice over the long term. When breastfeeding is delayed after birth, the consequences can be life-threatening and the longer newborns are left waiting, the greater the risk.

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.

We therefore proposed to compare impact of TAP block, epidural analgesia and iv multimodal analgesia after spinal analgesia on maternal comfort in patients with elective caesarean section. We will evaluate the following specific aims, all of which will be assessed over 72 hours, or the duration of hospitalization if shorter:

Primary Aim: To compare the effect of pain management after cesarean on the rates of initiation of breastfeeding in the first hour after birth and exclusive breast milk in the first 72 hours in elective cesarean deliveries with spinal anesthesia.

Secondary Aim 1: To compare the effect of pain management after cesarean on the rates of the confidence and comfort of breastfeeding mothers after elective cesarean deliveries with spinal anesthesia.

Hypothesis. 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.

3. Method and Study Design A. Study Overview A randomized double-blind trial is designed comparing TAP blocks , epidural analgesia and ıv multimodal analgesia and placebo in patients having elective inert cesarean deviveries with spinal anesthesia. The study will be performed at Konya City Hospital with IRB approval and written consent from patients.

B. Setting and Population

Inclusion criteria:

  • Written informed consent;
  • 18-45 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.

Exclusion criteria:

  • 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;

C. Withdrawal Criteria Patients will be free to withdraw from study at any time. Patients will also be removed from study at any time for adverse events, or deemed necessary for patient safety.

02

Conditions studied

  • Breast Feeding
  • Analgesia

Keywords

  • Post-cesarean analgesia
  • Breastfeeding
  • latch score
  • visuel pain score
03

In context

Breast Feeding

262 studies on the registry are indexed under Breast Feeding; 112 are open to participants now.

This study's enrollment of 75 is below the median of 95 across 210 interventional studies indexed under Breast Feeding.

Browse Breast Feeding studies →

Lead sponsor

Konya City Hospital is the lead sponsor of 76 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Written informed consent;
  • 18-45 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
75 participants (actual)

Study arms

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

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

    Procedure: Analgesia

  • Active comparator
    Arm E : Epidural Analgesia with bupivacaine

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

    Procedure: Analgesia

  • Active comparator
    Arm M: Iv Multimodal Analgesia with paracetamol or tramadol

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

    Procedure: Analgesia

Interventions

  • ProcedureAnalgesia

    Postoperatively, patients will be given analgesia

06

What researchers measure

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.

    Time frame: 1 year

07

Study locations

1 site
  • Konya City Hospital
    Konya, 42080, Turkey (Türkiye)
08

References and documents

Publications

  • MacGregor E, Hughes M. Breastfeeding experiences of mothers from disadvantaged groups: a review. Community Pract. 2010 Jul;83(7):30-3. PubMed 20701189 ↗

Related links

Individual participant data

Plan to share: Yes — The protocol can be shared once the study is completed

Supporting information: Study protocol

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06682871
Lead sponsor
Konya City Hospital
Responsible party
RAMAZAN KEÇECİ (NEONATOLOGIST, MD, PRINCIPAL INVESTIGATOR, Konya City Hospital) — Principal investigator
First posted
Nov 12, 2024
Start date
Jan 1, 2024
Primary completion
Jul 23, 2025
Completion
Jul 25, 2025
Last update
Sep 3, 2025

Study contacts

Ramazan Keçeci, Specialist
principal investigator · Konya City Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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