Complications; Cesarean SectionNCT02893696
Extra Sitting Time After Spinal Anesthesia for Cesarean Section and Fetal Well-being
A study testing Various sitting time in people with Complications; Cesarean Section and Hypotension, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
After injection of the spinal anesthetic drug, women will be allowed to lie down immediately (0-30 sec) or after three minutes (180 sec) of sitting. The incidence of maternal hypotension and fetal umbilical cord blood pH will be recorded. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Complications; Cesarean Section, Hypotension
- What is being tested?
- Various sitting time
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2018to Apr 2020
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women with elective cesarean delivery at 39-42 wks gestation.
Who cannot join
- Women who shorter than 5'0" in height, those with primary or pregnancy-induced hypertension, macrosomia, multiple gestation will be excluded.
- Women with known risks of bleeding or potential hysterectomy such as those with placenta previa or accrete will also be excluded.
- If the epidural catheter cannot be placed within the specific time frame after the spinal injection, the case will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: The Effect of Sitting After Spinal Injection of Hyperbaric Local Anesthetic on Fetal Acid-base Balance After Cesarean Delivery
After injection of the spinal anesthetic drug, women will be allowed to lie down immediately (0-30 sec) or after three minutes (180 sec) of sitting. The incidence of maternal hypotension and fetal umbilical cord blood pH will be recorded.
- Conditions
- Complications; Cesarean Section, Hypotension
- Being tested
- Various sitting time
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Various sitting timeOther
Various sitting time
| Study group | Role | What they receive |
|---|---|---|
| Immediately Supine Position | Active comparator | Women placed in supine position within 30 seconds after spinal injection of local anesthetic drug. Receives: Other: Various sitting time |
| Delayed Supine Position | Active comparator | Women placed in supine position after three minutes of seating after spinal injection of local anesthetic drug. Receives: Other: Various sitting time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of fetal umbilical artery pH below 7.20
Measured: At fetal delivery
Secondary outcomes (1)
Incidence of maternal hypotension
Measured: During cesarean surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startMar 2018 (estimated)
- Primary completionMar 2019 (estimated)
- Study completionApr 2020 (estimated)
Why it stopped: no enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications; Cesarean SectionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weike Tao, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893696
- Sponsor's protocol ID
- STU012016-059
- Status last verified
- Jan 2019
- First submitted
- 2 Sep 2016
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sitting After Spinal Injection of Hyperbaric Local Anesthetic on Fetal Acid-base Balance After Cesarean Delivery
- ClinicalTrials.gov ID
- NCT02893696
- Acronym / sponsor ID
- STU012016-059
- Conditions
- Complications; Cesarean Section, Hypotension
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Mar 2018 (estimated)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 8 Sep 2016 (estimated)
- 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.
After injection of the spinal anesthetic drug, women will be allowed to lie down immediately (0-30 sec) or after three minutes (180 sec) of sitting. The incidence of maternal hypotension and fetal umbilical cord blood pH will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediately Supine Position | Active comparator | Other: Various sitting timeWomen placed in supine position within 30 seconds after spinal injection of local anesthetic drug. |
| Delayed Supine Position | Active comparator | Other: Various sitting timeWomen placed in supine position after three minutes of seating after spinal injection of local anesthetic drug. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women with elective cesarean delivery at 39-42 wks gestation.
Key exclusion criteria (3 listed)
- Women who shorter than 5'0" in height, those with primary or pregnancy-induced hypertension, macrosomia, multiple gestation will be excluded.
- Women with known risks of bleeding or potential hysterectomy such as those with placenta previa or accrete will also be excluded.
- If the epidural catheter cannot be placed within the specific time frame after the spinal injection, the case will be excluded.
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 |
|---|---|---|
| Various sitting timeVarious sitting time | Other | Delayed Supine Position, Immediately Supine Position |
Primary outcome
Incidence of fetal umbilical artery pH below 7.20
Time frame: At fetal delivery
1 secondary outcome
Incidence of maternal hypotension
Time frame: During cesarean surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Individual participant dataSharing planned: No
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Evaluation of Consciousness Depth (qCON) and Analgesia Depth (qNOX) Indices in General Anesthesia
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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.
Weike Tao, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Various sitting time in people with Complications; Cesarean Section and Hypotension, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 3 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: withdrawn, as of the sponsor's last update on 31 Jan 2019. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Incidence of fetal umbilical artery pH below 7.20 (time frame: At fetal delivery). 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 31 Jan 2019.