Cesarean SectionNCT02872181
An Evaluation of Maternal Position During Cesarean Delivery
A study testing Supine and Left uterine displacement in people with Cesarean Section, run by Hartford Hospital at 1 site in United States.
Trial summary
During Cesarean Delivery pregnant women are frequently tilted to the left 15 degress to reduce compression of the major blood vessels by the uterus. Despite this common practice, there is no conclusive evidence to support this practice. In fact it may even be deleterious to have women positioned in this position. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Supine and Left uterine displacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to May 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- term pregnant women with an uncomplicated pregnancy course undergoing scheduled cesarean delivery
- ≥18 years old
- ASA 1 and 2 (i.e., patient is completely healthy (1) or has mild systemic disease (2)
- Able and willing to consent to participate
Who cannot join
- Males
- <18 years old
- maternal cardiac/pulmonary/hematologic disorders/renal failure
- drug/alcohol/tobacco use during pregnancy
- essential or pregnancy-induced hypertension
- diabetes greater than 10 years
Show all 19Show fewer
- pre-eclampsia or abruptio placenta
- <37 weeks gestation
- hemoglobin < 7 g/dL
- intrauterine growth retardation
- fetal distress or fetal anomaly
- Transverse lie
- Ruptured membranes
- Severe polyhydramnios or oligohydramnios
- Multiple gestation
- severe scoliosis or kyphosis,
- uterine abnormalities (e.g., large fibroids, bicornuate uterus)
- Failed spinal (sensory level < T6 after 15 minutes)
- need to convert to general anesthesia before delivery
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Hartford Hospital
Hartford, Connecticut, 06102
Adam Sachs, MD, 860-972-2117, asachs29@yahoo.com
About this study
Official title: A Randomized Controlled Trial Evaluating Maternal Tilt During Cesarean Section
During Cesarean Delivery pregnant women are frequently tilted to the left 15 degress to reduce compression of the major blood vessels by the uterus. Despite this common practice, there is no conclusive evidence to support this practice. In fact it may even be deleterious to have women positioned in this position. The aim of the study is to determine whether or not tilting women to the left during cesarean section (CS) is helpful or detrimental. The authors hypothesize that left uterine displacement of 15 degrees, which is commonly employed, is useless for preventing compression of these blood vessels. To investigate this question, women will be randomly assigned to either be tilted 15 degrees to the left during CS or positioned flat on the table. Fetal acid base status, vasopressor/phenylephrine use, patient satisfaction, maternal complications, and fetal complications will all be collected and compared.
- Conditions
- Cesarean Section
- Being tested
- Supine, Left uterine displacement
- Keywords
- Maternal Position, Tilt, Left Uterine Displacement, Cesarean Delivery, Cesarean Section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SupineProcedure or surgery
Placed in Supine position
Left uterine displacementProcedure or surgery
Placed in 15 degrees left uterine displacement
| Study group | Role | What they receive |
|---|---|---|
| BMI <30 | Experimental | Pregnant women undergoing C/S with BMI <30 Receives: Procedure: Supine; Procedure: Left uterine displacement |
| BMI 30-40 | Experimental | Pregnant women undergoing C/S with BMI 30-40 Receives: Procedure: Supine; Procedure: Left uterine displacement |
| BMI >40 | Experimental | Pregnant women undergoing C/S with BMI >40 Receives: Procedure: Supine; Procedure: Left uterine displacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
neonatal base deficit from uterine artery immediately after cesarean delivery of the fetus
Measured: One data point will be used. The neonatal gas from the uterine artery immediately after delivery
Secondary outcomes (2)
total phenylephrine use in micrograms prior to delivery
Measured: The aggregate of the phenylephrine used immediately after spinal (total of 20 minutes) or until delivery of the baby
APGAR scores of the newborn as assessed by the neonatologist immediately after cesarean delivery
Measured: 1 and 5 minute apgar scores of the newborn fetus will be compared
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- adam sachs, MD, Principal investigator, Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872181
- Sponsor's protocol ID
- HartfordH
- Status last verified
- Jul 2018
- First submitted
- 25 Jan 2016
- Last updated
- 1 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating Maternal Tilt During Cesarean Section
- ClinicalTrials.gov ID
- NCT02872181
- Acronym / sponsor ID
- HartfordH
- Conditions
- Cesarean Section
- Keywords
- Maternal Position, Tilt, Left Uterine Displacement, Cesarean Delivery, Cesarean Section
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 19 Aug 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.
During Cesarean Delivery pregnant women are frequently tilted to the left 15 degress to reduce compression of the major blood vessels by the uterus. Despite this common practice, there is no conclusive evidence to support this practice. In fact it may even be deleterious to have women positioned in this position. The aim of the study is to determine whether or not tilting women to the left during cesarean section (CS) is helpful or detrimental. The authors hypothesize that left uterine displacement of 15 degrees, which is commonly employed, is useless for preventing compression of these blood vessels. To investigate this question, women will be randomly assigned to either be tilted 15 degrees to the left during CS or positioned flat on the table. Fetal acid base status, vasopressor/phenylephrine use, patient satisfaction, maternal complications, and fetal complications will all be collected and compared.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BMI <30 | Experimental | Procedure: Supine, Procedure: Left uterine displacementPregnant women undergoing C/S with BMI <30 |
| BMI 30-40 | Experimental | Procedure: Supine, Procedure: Left uterine displacementPregnant women undergoing C/S with BMI 30-40 |
| BMI >40 | Experimental | Procedure: Supine, Procedure: Left uterine displacementPregnant women undergoing C/S with BMI >40 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- term pregnant women with an uncomplicated pregnancy course undergoing scheduled cesarean delivery
Key exclusion criteria (19 listed)
- Males
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 |
|---|---|---|
| SupinePlaced in Supine position | Procedure or surgery | BMI 30-40, BMI <30, BMI >40 |
| Left uterine displacementPlaced in 15 degrees left uterine displacement | Procedure or surgery | BMI 30-40, BMI <30, BMI >40 |
Primary outcome
neonatal base deficit from uterine artery immediately after cesarean delivery of the fetus
Time frame: One data point will be used. The neonatal gas from the uterine artery immediately after delivery
2 secondary outcomes
total phenylephrine use in micrograms prior to delivery
Time frame: The aggregate of the phenylephrine used immediately after spinal (total of 20 minutes) or until delivery of the baby
APGAR scores of the newborn as assessed by the neonatologist immediately after cesarean delivery
Time frame: 1 and 5 minute apgar scores of the newborn fetus will be compared
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
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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.
adam sachs, MD principal investigator
Hartford 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 Supine and Left uterine displacement in people with Cesarean Section, run by Hartford Hospital 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 4 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 1 Aug 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact adam sachs, MD (860-972-2117, asachs29@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neonatal base deficit from uterine artery immediately after cesarean delivery of the fetus (time frame: One data point will be used. The neonatal gas from the uterine artery immediately after 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 1 Aug 2018.