Transient Tachypnea of Newborn and Fetal AcidosisNCT06383624
Impact Of Maternal Spinal Anesthesia-Induced Hypotension At Scheduled Cesarean Delivery On Risk Development Of Transient Tachypnea Of Newborn And Fetal Acidosis
An observational study of Transient Tachypnea of Newborn and Fetal Acidosis, run by Benha University at 1 site in Egypt.
Trial summary
We will evaluate the association between transient tachypnea of newborns and fetal acidosis development to the degree and duration of maternal hypotension and anesthesia to delivery time during spinal anesthesia at scheduled cesarean delivery. Read more about this study
- Who is it for?
- Ages 1 minute to 6 hours
- Conditions the study is for
- Transient Tachypnea of Newborn and Fetal Acidosis
- How many people
- 115 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 31 Mar 2024
- Phase
- Observational
- 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 1 minute to 6 hours
- All sexes
- No healthy volunteers
- Child
Study population: All fullterm neonates born via scheduled cesarean delivery between April 2023 and March 2023 will be included in our study. All methods will be carried out in accordance with relevant guidelines and regulations.
Who may be able to join
- Apparently normal singleton pregnancies with gestational age ≥37 weeks who will be underwent a scheduled elective cesarean section under spinal anesthesia.
Who cannot join
- - Multiple pregnancies.
- - Gestational age < 37 weeks.
- - Neonates with congenital anomalies.
- - Maternal exposure to antenatal steroids
- - Mothers with medical problems as gestational or chronic diabetes mellitus and pregnancy induced hypertension or chronic hypertension.
- - Induced or spontaneous onset of labor.
- - Combined spinal-epidural anesthetic during which epidural activation is necessary before delivery .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact Of Maternal Spinal Anesthesia-Induced Hypotension At Scheduled Cesarean Delivery On Risk Development Of Transient Tachypnea Of Newborn And Fetal Acidosis: A Prospective Study
We will evaluate the association between transient tachypnea of newborns and fetal acidosis development to the degree and duration of maternal hypotension and anesthesia to delivery time during spinal anesthesia at scheduled cesarean delivery.
Read the detailed description
Transient tachypnea of the newborn (TTN) is characterized by mild to moderate respiratory distress that is a common self-limited disease of term newborns which gradually improves during the first 48 to 72 hours of life. TTN results from failure of the newborn to effectively clear the fetal lung fluid soon after birth.
It requires admission to the neonatal intensive care unit which leads to maternal-infant separation, the need for respiratory support, extended unnecessary exposure to antibiotics, prolonged hospital stays and increased health care costs.
Furthermore, these term neonates are at higher risk for inpatient admission for respiratory syncytial virus bronchiolitis in infancy and reactive airway disease later in life.
Transient tachypnea of newborns is 2- to 6-fold more common during elective cesarean delivery compared to vaginal birth.
Although the maternal-fetal risk factors for transient tachypnea of newborns are well understood, preoperative factors, especially in the setting of elective cesarean delivery, remain poorly investigated.
Significant maternal hypotension is a frequent complication of spinal anesthesia during caesarean delivery. However, spinal anesthesia is still the preferred anesthetic technique for cesarean delivery due to multiple factors such as avoiding risk of aspiration associated with general anesthetic, maternal ability to witness the birth of the baby and higher neonatal APGAR scores.
To our knowledge, no study has explored the potential role of maternal hemodynamic parameters during neuraxial anesthesia and effect of anesthesia to delivery time at scheduled cesarean delivery in the development of transient tachypnea of newborns and fetal acidosis in Egypt. Therefore, we hypothesized that pre-delivery maternal spinal anesthesia induced hypotension and anesthesia to delivery time would be associated with transient tachypnea of newborns and fetal acidosis in fullterm neonates delivered by elective cesarean section.
To test this hypothesis, we performed a prospective observational cohort study to evaluate the association of degree and duration of maternal hypotension and anesthesia to delivery time with development of transient tachypnea of newbon and fetal acidosis.
- Keywords
- Transient tachypnea of newborn, Fetal acidosis, Spinal anesthesia, Scheduled cesarean section
- Medical subject headings
- Transient Tachypnea of the Newborn
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between transient tachypnea of newborns development to the degree and duration of maternal hypotension during spinal anesthesia at scheduled cesarean delivery
We will evaluate the association between transient tachypnea of newborns development to the degree and duration of maternal hypotension and anesthesia to delivery time during spinal anesthesia at scheduled cesarean delivery
Measured: 6 hours after delivery
Association between fetal acidosis development to the degree and duration of maternal hypotension and anesthesia to delivery time during spinal anesthesia at scheduled cesarean delivery
we will evaluate the association between fetal acidosis development to the degree and duration of maternal hypotension and anesthesia to delivery time during spinal anesthesia at scheduled cesarean delivery
Measured: 1 hour after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start1 Apr 2023
- Primary completion1 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transient Tachypnea of Newborn and Fetal AcidosisStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Mohammed El-Rebigi, MD, Benha University
- Investigators
- Amany M. El-Rebigi, MD, Principal investigator, lecturer of pediatric and neonatology, Faculty of medicine, Benha University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383624
- Sponsor's protocol ID
- RC18-4-2023
- Status last verified
- Apr 2024
- First submitted
- 21 Apr 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Of Maternal Spinal Anesthesia-Induced Hypotension At Scheduled Cesarean Delivery On Risk Development Of Transient Tachypnea Of Newborn And Fetal Acidosis: A Prospective Study
- ClinicalTrials.gov ID
- NCT06383624
- Acronym / sponsor ID
- RC18-4-2023
- Keywords
- Transient tachypnea of newborn, Fetal acidosis, Spinal anesthesia, Scheduled cesarean section
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 25 Apr 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.
We will evaluate the association between transient tachypnea of newborns and fetal acidosis development to the degree and duration of maternal hypotension and anesthesia to delivery time during spinal anesthesia at scheduled cesarean delivery.
Detailed description
Transient tachypnea of the newborn (TTN) is characterized by mild to moderate respiratory distress that is a common self-limited disease of term newborns which gradually improves during the first 48 to 72 hours of life. TTN results from failure of the newborn to effectively clear the fetal lung fluid soon after birth.
It requires admission to the neonatal intensive care unit which leads to maternal-infant separation, the need for respiratory support, extended unnecessary exposure to antibiotics, prolonged hospital stays and increased health care costs.
Furthermore, these term neonates are at higher risk for inpatient admission for respiratory syncytial virus bronchiolitis in infancy and reactive airway disease later in life.
Transient tachypnea of newborns is 2- to 6-fold more common during elective cesarean delivery compared to vaginal birth.
Although the maternal-fetal risk factors for transient tachypnea of newborns are well understood, preoperative factors, especially in the setting of elective cesarean delivery, remain poorly investigated.
Significant maternal hypotension is a frequent complication of spinal anesthesia during caesarean delivery. However, spinal anesthesia is still the preferred anesthetic technique for cesarean delivery due to multiple factors such as avoiding risk of aspiration associated with general anesthetic, maternal ability to witness the birth of the baby and higher neonatal APGAR scores.
To our knowledge, no study has explored the potential role of maternal hemodynamic parameters during neuraxial anesthesia and effect of anesthesia to delivery time at scheduled cesarean delivery in the development of transient tachypnea of newborns and fetal acidosis in Egypt. Therefore, we hypothesized that pre-delivery maternal spinal anesthesia induced hypotension and anesthesia to delivery time would be associated with transient tachypnea of newborns and fetal acidosis in fullterm neonates delivered by elective cesarean section.
To test this hypothesis, we performed a prospective observational cohort study to evaluate the association of degree and duration of maternal hypotension and anesthesia to delivery time with development of transient tachypnea of newbon and fetal acidosis.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 minute to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All fullterm neonates born via scheduled cesarean delivery between April 2023 and March 2023 will be included in our study. All methods will be carried out in accordance with relevant guidelines and regulations.
Key inclusion criteria (1 listed)
- Apparently normal singleton pregnancies with gestational age ≥37 weeks who will be underwent a scheduled elective cesarean section under spinal anesthesia.
Key exclusion criteria (7 listed)
- - Multiple pregnancies.
- - Gestational age < 37 weeks.
- - Neonates with congenital anomalies.
- - Maternal exposure to antenatal steroids
- - Mothers with medical problems as gestational or chronic diabetes mellitus and pregnancy induced hypertension or chronic hypertension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between transient tachypnea of newborns development to the degree and duration of maternal hypotension during spinal anesthesia at scheduled cesarean delivery
Time frame: 6 hours after delivery
We will evaluate the association between transient tachypnea of newborns development to the degree and duration of maternal hypotension and anesthesia to delivery time during spinal anesthesia at scheduled cesarean delivery
Association between fetal acidosis development to the degree and duration of maternal hypotension and anesthesia to delivery time during spinal anesthesia at scheduled cesarean delivery
Time frame: 1 hour after delivery
we will evaluate the association between fetal acidosis development to the degree and duration of maternal hypotension and anesthesia to delivery time during spinal anesthesia at scheduled cesarean delivery
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 25 Apr 2024.
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.
Amany M. El-Rebigi, MD principal investigator
lecturer of pediatric and neonatology, Faculty of medicine, Benha University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transient Tachypnea of Newborn and Fetal Acidosis, run by Benha University at 1 site in Egypt.
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 1 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 25 Apr 2024. 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 Egypt. 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?
Association between transient tachypnea of newborns development to the degree and duration of maternal hypotension during spinal anesthesia at scheduled cesarean delivery (time frame: 6 hours after delivery). The study lists 2 primary outcomes in all. 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 25 Apr 2024.