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).
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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.
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.
- 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.
- 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;
- 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.
- Conditions
- Breast Feeding, Analgesia
- 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 group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted12 Nov 2024
- Study start1 Mar 2024
- Primary completion23 Jul 2025
- Study completion25 Jul 2025
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 Breast FeedingStudies of the same condition, open and under way.
- 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 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)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAMAZAN KEÇECİ, Konya City Hospital
- Investigators
- Ramazan Keçeci, Specialist, Principal investigator, Konya City Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06682871
- Acronym / sponsor ID
- 2024/4806
- Conditions
- Breast Feeding, Analgesia
- Keywords
- Post-cesarean analgesia, Breastfeeding, latch score, visuel pain score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 23 Jul 2025 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 12 Nov 2024 (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.
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.
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.
- 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.
- 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;
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm T: Transversus Abdominis Plane (TAP) blocks with bupivacaine | Active comparator | Procedure: AnalgesiaInfants of mothers who received 4-Quadrant TAP block after inactive elective spinal cesarean section (25 patients) |
| Arm E : Epidural Analgesia with bupivacaine | Active comparator | Procedure: AnalgesiaInfants of mothers who received Epidural analgesia after inactive elective spinal cesarean section (25 patients) |
| 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) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Written informed consent;
- 18-45 years old;
- ASA Physical Status 1-3;
- Scheduled for elective cesarien delivery;
- Anticipated hospitalization of at least three nights;
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| AnalgesiaPostoperatively, patients will be given analgesia | Procedure or surgery | Arm E : Epidural Analgesia with bupivacaine, Arm T: Transversus Abdominis Plane (TAP) blocks with bupivacaine |
Primary outcome
To compare the effect of pain management after cesarean on the rates of initiation of breastfeeding
Time frame: 1 year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Results publication: PubMed 20701189MacGregor E, Hughes M. Breastfeeding experiences of mothers from disadvantaged groups: a review. Community Pract. 2010 Jul;83(7):30-3.
- PUBMEDLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The protocol can be shared once the study is completed
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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. This study is not recruiting at the moment.
Ramazan Keçeci, Specialist principal investigator
Konya City Hospital
1 site in 1 country: see every site and its status.
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.