Epidural Anesthesia in Labor and DeliveryNCT07077785
The Effects of Epidural Analgesia on Maternal-Infant Bonding and Birth-Related Trauma
A study testing Epidural Analgesia in people with Epidural Anesthesia in Labor and Delivery, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective, single-center study aims to evaluate the effects of epidural analgesia on maternal-infant bonding and perceived birth-related trauma in women undergoing vaginal delivery. Participants will be randomly allocated to receive either labor epidural analgesia or standard non-neuraxial analgesic care. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epidural Anesthesia in Labor and Delivery
- What is being tested?
- Epidural Analgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jul 2025to 15 Sep 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female participants aged between 18 and 40 years
- ASA physical status classification I or II
- Pregnant women undergoing spontaneous vaginal delivery at the study hospital
- Willingness to provide informed consent and participate in study procedures
Who cannot join
- Age below 18
- ASA physical status classification III or IV
- Morbid obesity (BMI ≥ 40 kg/m²)
- Indication for cesarean section
- History of local anesthetic toxicity or allergy
- Contraindications to epidural analgesia (e.g., coagulopathy, infection at insertion site)
- Any significant maternal or fetal complication that contraindicates study participation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adıyaman University Training and Research Hospital
Adıyaman, 02200
About this study
Official title: The Effects of Epidural Analgesia on Maternal-Infant Bonding and Birth-Related Trauma in Women Undergoing Vaginal Delivery With Epidural Analgesia
This prospective, single-center study aims to evaluate the effects of epidural analgesia on maternal-infant bonding and perceived birth-related trauma in women undergoing vaginal delivery. Participants will be randomly allocated to receive either labor epidural analgesia or standard non-neuraxial analgesic care. Standardized questionnaires will be used to assess pain perception, maternal satisfaction, and the quality of early bonding between mother and infant. The study is designed in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines, with approval from the local ethics committee.
Read the detailed description
This prospective, randomized, controlled, single-center clinical trial that will be conducted at Adıyaman University Training and Research Hospital, Department of Obstetrics and Gynecology. The aim is to investigate the impact of epidural analgesia on maternal-infant bonding and birth-related psychological trauma among women undergoing spontaneous vaginal delivery.
Eligible participants will include pregnant women aged between 18 and 40 years with ASA physical status I or II, who are planning vaginal delivery. Women with contraindications to epidural analgesia, morbid obesity, previous local anesthetic toxicity, or indications for cesarean section will be excluded.
Based on a priori power analysis, 40 participants will be recruited into each group to account for potential dropout, totaling 80 participants. Group E will consist of women who receive epidural analgesia during labor, while Group C will include those who undergo vaginal delivery without any epidural intervention.
Epidural analgesia will be administered via catheter placement at the L3-L4 vertebral level. Following a test dose with lidocaine, patients will receive a combination of 0.2% bupivacaine and 25 mcg fentanyl once cervical dilatation reaches 5 cm. Additional boluses may be administered as required based on pain levels.
Participants will be assessed for pain intensity using the Visual Analog Scale (VAS) during and after delivery. Postpartum satisfaction and early breastfeeding status will be recorded prior to discharge. At one month postpartum, all participants will complete validated questionnaires, including a birth-related trauma scale(City Birth Trauma Scale) and the Maternal Attachment Inventory, to assess psychological outcomes and maternal-infant bonding.
The results of this study are expected to contribute to a better understanding of the psychological and emotional consequences of epidural analgesia in vaginal deliveries and help optimize maternal care practices.
- Being tested
- Epidural Analgesia
- Keywords
- epidural analgesia, maternal-infant bonding, Psychological Birth Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural AnalgesiaProcedure or surgery
After informed consent and exclusion of contraindications, an epidural catheter will be placed at the L3-L4 interspace in the sitting position using a Tuohy needle. A test dose of 2 mL lidocaine will be administered to confirm correct catheter placement under continuous monitoring of vital signs. Once cervical dilatation reaches 5 cm, 5 mL of 0.2% bupivacaine combined with 25 mcg fentanyl will be administered via the epidural catheter. Additional boluses will be given as needed based on pain assessment. The catheter will be removed 24 hours postpartum.
| Study group | Role | What they receive |
|---|---|---|
| Epidural group- group E | Experimental | Participants in this group will receive epidural analgesia during vaginal delivery Receives: Procedure: Epidural Analgesia |
| Control group- group C | No intervention | Participants in this group will undergo vaginal delivery without receiving any form of neuraxial analgesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Epidural Analgesia on Maternal-Infant Bonding Quality and Birth-Related Psychological Stress
Assessment of maternal-infant bonding quality using the Maternal Attachment Inventory (MAI) and evaluation of birth-related psychological stress using a validated childbirth trauma scale. Outcomes will be measured via structured questionnaires administered at 1 month postpartum to evaluate the psychological impact of epidural analgesia during vaginal delivery. Score range: 26-104; higher scores indicate stronger maternal-infant attachment.
Measured: 1 month postpartum
Secondary outcomes (1)
Pain Intensity During Labor Assessed by Visual Analog Scale (VAS)
Evaluation of maternal pain intensity during labor using the Visual Analog Scale (VAS). Pain scores will be recorded at predefined intervals, including active labor and immediately postpartum. Minimum score: 0; maximum score: 10. Higher scores indicate greater pain intensity, while lower scores indicate less pain.
Measured: From labor onset until discharge (approximately 0 to 48 hours postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start25 Jul 2025
- Primary completion30 Aug 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidural Anesthesia in Labor and DeliveryStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, single-center, parallel-group clinical study designed to evaluate the psychological impact of epidural analgesia on childbirth-related outcomes. The study will compare two groups of women undergoing vaginal delivery: those receiving epidural analgesia and those not receiving it. Outcomes such as perceived pain (VAS), maternal satisfaction, psychological stress related to childbirth, and early maternal-infant bonding will be assessed through validated scales administered during hospitalization and at 1-month postpartum.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman University Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nezir Yılmaz, Adiyaman University Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077785
- Sponsor's protocol ID
- ADYU-ANS-NY-011
- Status last verified
- Aug 2026
- First submitted
- 12 Jul 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Epidural Analgesia on Maternal-Infant Bonding and Birth-Related Trauma in Women Undergoing Vaginal Delivery With Epidural Analgesia
- ClinicalTrials.gov ID
- NCT07077785
- Acronym / sponsor ID
- ADYU-ANS-NY-011
- Keywords
- epidural analgesia, maternal-infant bonding, Psychological Birth Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 22 Jul 2025 (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.
This prospective, single-center study aims to evaluate the effects of epidural analgesia on maternal-infant bonding and perceived birth-related trauma in women undergoing vaginal delivery. Participants will be randomly allocated to receive either labor epidural analgesia or standard non-neuraxial analgesic care. Standardized questionnaires will be used to assess pain perception, maternal satisfaction, and the quality of early bonding between mother and infant. The study is designed in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines, with approval from the local ethics committee.
Detailed description
This prospective, randomized, controlled, single-center clinical trial that will be conducted at Adıyaman University Training and Research Hospital, Department of Obstetrics and Gynecology. The aim is to investigate the impact of epidural analgesia on maternal-infant bonding and birth-related psychological trauma among women undergoing spontaneous vaginal delivery.
Eligible participants will include pregnant women aged between 18 and 40 years with ASA physical status I or II, who are planning vaginal delivery. Women with contraindications to epidural analgesia, morbid obesity, previous local anesthetic toxicity, or indications for cesarean section will be excluded.
Based on a priori power analysis, 40 participants will be recruited into each group to account for potential dropout, totaling 80 participants. Group E will consist of women who receive epidural analgesia during labor, while Group C will include those who undergo vaginal delivery without any epidural intervention.
Epidural analgesia will be administered via catheter placement at the L3-L4 vertebral level. Following a test dose with lidocaine, patients will receive a combination of 0.2% bupivacaine and 25 mcg fentanyl once cervical dilatation reaches 5 cm. Additional boluses may be administered as required based on pain levels.
Participants will be assessed for pain intensity using the Visual Analog Scale (VAS) during and after delivery. Postpartum satisfaction and early breastfeeding status will be recorded prior to discharge. At one month postpartum, all participants will complete validated questionnaires, including a birth-related trauma scale(City Birth Trauma Scale) and the Maternal Attachment Inventory, to assess psychological outcomes and maternal-infant bonding.
The results of this study are expected to contribute to a better understanding of the psychological and emotional consequences of epidural analgesia in vaginal deliveries and help optimize maternal care practices.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, single-center, parallel-group clinical study designed to evaluate the psychological impact of epidural analgesia on childbirth-related outcomes. The study will compare two groups of women undergoing vaginal delivery: those receiving epidural analgesia and those not receiving it. Outcomes such as perceived pain (VAS), maternal satisfaction, psychological stress related to childbirth, and early maternal-infant bonding will be assessed through validated scales administered during hospitalization and at 1-month postpartum.
| Arm | Type | Receives |
|---|---|---|
| Epidural group- group E | Experimental | Procedure: Epidural AnalgesiaParticipants in this group will receive epidural analgesia during vaginal delivery |
| Control group- group C | No intervention | –Participants in this group will undergo vaginal delivery without receiving any form of neuraxial analgesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female participants aged between 18 and 40 years
- ASA physical status classification I or II
- Pregnant women undergoing spontaneous vaginal delivery at the study hospital
- Willingness to provide informed consent and participate in study procedures
Key exclusion criteria (7 listed)
- Age below 18
- ASA physical status classification III or IV
- Morbid obesity (BMI ≥ 40 kg/m²)
- Indication for cesarean section
- History of local anesthetic toxicity or allergy
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 |
|---|---|---|
| Epidural AnalgesiaAfter informed consent and exclusion of contraindications, an epidural catheter will be placed at the L3-L4 interspace in the sitting position using a Tuohy needle. A test dose of 2 mL lidocaine will be administered to confirm correct catheter placement under continuous monitoring of vital signs. Once cervical dilatation reaches 5 cm, 5 mL of 0.2% bupivacaine combined with 25 mcg fentanyl will be administered via the epidural catheter. Additional boluses will be given as needed based on pain assessment. The catheter will be removed 24 hours postpartum. | Procedure or surgery | Epidural group- group E |
Primary outcome
Effect of Epidural Analgesia on Maternal-Infant Bonding Quality and Birth-Related Psychological Stress
Time frame: 1 month postpartum
Assessment of maternal-infant bonding quality using the Maternal Attachment Inventory (MAI) and evaluation of birth-related psychological stress using a validated childbirth trauma scale. Outcomes will be measured via structured questionnaires administered at 1 month postpartum to evaluate the psychological impact of epidural analgesia during vaginal delivery. Score range: 26-104; higher scores indicate stronger maternal-infant attachment.
1 secondary outcome
Pain Intensity During Labor Assessed by Visual Analog Scale (VAS)
Time frame: From labor onset until discharge (approximately 0 to 48 hours postpartum)
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 19 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural Analgesia in people with Epidural Anesthesia in Labor and Delivery, run by Adiyaman University Research 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 4 inclusion and 7 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 19 Aug 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?
Effect of Epidural Analgesia on Maternal-Infant Bonding Quality and Birth-Related Psychological Stress (time frame: 1 month postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2026.