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Breast FeedingNCT06682871

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

A study testing Analgesia in people with Breast Feeding and Analgesia, run by Konya City Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Breast Feeding, Analgesia
What is being tested?
Analgesia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2024to 25 Jul 2025
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 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Konya City Hospital

    Konya, Turkey, 42080

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect Of Post-Birth Analgesia Interventions Performed To Purposed Of Elective Cesarean Delivery With Spinal Anesthesia In Our Hospital On The Initiating Of Breastfeeding And Exclusive Breastfeeding.

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.

  1. 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.
  2. 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;
  1. 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.
Being tested
Analgesia
Keywords
Post-cesarean analgesia, Breastfeeding, latch score, visuel pain score
Medical subject headings
Breast Feeding, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AnalgesiaProcedure or surgery

    Postoperatively, patients will be given analgesia

Study groups in NCT06682871
Study groupRoleWhat they receive
Arm T: Transversus Abdominis Plane (TAP) blocks with bupivacaineActive comparatorInfants of mothers who received 4-Quadrant TAP block after inactive elective spinal cesarean section (25 patients)
Receives: Procedure: Analgesia
Arm E : Epidural Analgesia with bupivacaineActive comparatorInfants of mothers who received Epidural analgesia after inactive elective spinal cesarean section (25 patients)
Receives: Procedure: Analgesia
Arm M: Iv Multimodal Analgesia with paracetamol or tramadolActive comparatorInfants of mothers who received Multimodal intravenous analgesia after inactive elective spinal cesarean section (25 patients)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2024
  2. Study start1 Mar 2024
  3. Primary completion23 Jul 2025
  4. Study completion25 Jul 2025

Resources

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
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06682871
Sponsor's protocol ID
2024/4806
Status last verified
Oct 2026
First submitted
21 Oct 2024
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The protocol can be shared once the study is completed

Publications

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

    PubMed 20701189

Questions about this trial

What is this clinical trial studying?

A study testing Analgesia in people with Breast Feeding and Analgesia, run by Konya City Hospital at 1 site in Turkey (Türkiye).

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 7 inclusion and 5 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 26 Oct 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 Turkey (Türkiye). 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?

To compare the effect of pain management after cesarean on the rates of initiation of breastfeeding (time frame: 1 year). 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 NCT06682871, 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 26 Oct 2026.

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