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Morbid ObesityNCT04993651

Effect of CPAP on Fetal pH at Scheduled C-section in Morbidly Obese Women

A study testing CPAP in people with Morbid Obesity and Cesarean Delivery Affecting Fetus, run by Eastern Virginia Medical School at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of our study is to evaluate the effect of CPAP on umbilical cord acid base status in morbidly obese women at the time of scheduled cesarean delivery. We hypothesize that neonates born to mothers wearing CPAP during the cesarean section will have a higher umbilical artery pH. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
What is being tested?
CPAP
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteUnited States
Study dates
11 Oct 2021to 30 Jun 2023
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
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Pregnant women between the ages of 18-45
  • Body mass index of 40 kg/m2 or greater at the time patient is scheduled for cesarean delivery
  • Singleton gestation
  • Scheduled for primary or repeat cesarean delivery at Sentara Norfolk General Hospital
  • Gestational age between 37+0 and 41+0 weeks at the time of delivery
  • Non-stress test on admission with moderate variability, without repetitive late or variable decelerations
  • Negative SARS-CoV-2 PCR test within 72 hours of procedure

Who cannot join

  • Fetal growth restriction
  • Active pulmonary diseases to include pneumonia, sarcoidosis, pulmonary hypertension, moderate or severe persistent asthma
  • Suspected placenta accreta based on prenatal sonographic evaluation
  • Active maternal infection to include pyelonephritis, appendicitis, upper respiratory tract infection, urinary tract infection or suspected intra-amniotic infection
  • SARS-CoV-2 positive test within past 10 days or ongoing symptoms of SARS-CoV-2 to include cough, fever or shortness of breath with positive test greater than 10 days prior, or history of hospitalization for SARS-CoV-2 infection
  • Fetus with aneuploidy or major anomaly
  • Enrolled in another trial that may affect outcome

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Eastern Virginia Medical School

    Norfolk, Virginia, 23507

Other trials in United States

About this study

Official title: Effect of Continuous Positive Airway Pressure on Fetal pH at Time of Scheduled Cesarean Delivery in Morbidly Obese Women

The objective of our study is to evaluate the effect of CPAP on umbilical cord acid base status in morbidly obese women at the time of scheduled cesarean delivery. We hypothesize that neonates born to mothers wearing CPAP during the cesarean section will have a higher umbilical artery pH.

Read the detailed description

This is a randomized control trial comparing CPAP to routine airway management in morbidly obese patients undergoing scheduled cesarean delivery. Morbidly obese women meeting criteria for inclusion will be approached for participation. Women who are scheduled for cesarean delivery at Sentara Norfolk General Hospital will be approached at a prenatal appointment prior to scheduled date of delivery. If a woman agrees to participate in the study, she will be counseled and consented at that time.

Being tested
CPAP
Keywords
Fetal pH, CPAP, Continuous Positive Airway Pressure
Medical subject headings
Obesity, Morbid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CPAPDevice

    Also called Continuous Positive Airway Pressure

    CPAP is a form of noninvasive positive pressure ventilation (NPPV). CPAP works to maintain adequate levels of PO2 and PCO2 through improved alveolar ventilation and maintenance of upper-airway patency.

Study groups in NCT04993651
Study groupRoleWhat they receive
Continuous Positive Airway PressureExperimentalThose randomized to CPAP will be fitted with CPAP face mask or nasal device by the respiratory therapist and permitted to trial the machine to ensure proper use and fit. CPAP settings: CPAP AUTO 5-20 cm H20 will be utilized. The CPAP device will then be removed. The subject will then be placed in the supine position with a standard roll placed under the right maternal hip. Those randomized to CPAP will have the device applied and machine turned on. For those randomized to routine airway management, nasal cannula with oxygen 2L/min will be applied and this will be titrated to achieve a maternal SpO2 > 95%. End tidal CO2 monitors will be applied to both patient groups.
Receives: Device: CPAP
Nasal CannulaNo interventionFor those randomized to routine airway management, nasal cannula with oxygen 2L/min will be applied and this will be titrated to achieve a maternal SpO2 > 95%. End tidal CO2 monitors will be applied to both patient groups.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Umbilical Cord Arterial pH

    We hypothesize that neonates born to mothers wearing CPAP during the cesarean section will have a higher umbilical artery pH.

    Measured: At delivery

Secondary outcomes (6)

  1. Patient satisfaction with use of CPAP

    Survey will be used to determine patient experience and satisfaction

    Measured: Within 4 days following delivery (prior to discharge from hospital)

  2. Effect of CPAP on maternal acid base status with analysis of venous blood gas

    Maternal venous blood gas will be analyzed at the time of uterine incision to measure the acid base status

    Measured: At time of uterine incision

  3. Effect of maternal CPAP use on neonatal Apgar scores

    Apgar scores will be compared between 2 groups

    Measured: At delivery

  4. Effect of maternal CPAP use on composite neonatal outcome

    Perinatal death, respiratory support, Apgar score <=3 at 5 min, hypoxic ischemic encephalopathy, hypotension requiring vasopressor support

    Measured: At delivery

  5. Effect of duration in supine position prior to delivery on neonatal acid base status

    Neonatal venous blood gas will be analyzed to determine the acid base status as it correlates to length of time in maternal supine position

    Measured: At delivery

  6. Effect of duration in supine position prior to delivery on maternal acid base status

    Maternal venous blood gas will be analyzed to determine the acid base status as it correlates to length of time in supine position

    Measured: At delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2021
  2. Study start11 Oct 2021
  3. Primary completion9 May 2023
  4. Study completion30 Jun 2023

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04993651
Sponsor's protocol ID
CPAP on Fetal pH
Status last verified
Sep 2024
First submitted
21 Jun 2021
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Flegal KM, Kruszon-Moran D, Carroll MD, Fryar CD, Ogden CL. Trends in Obesity Among Adults in the United States, 2005 to 2014. JAMA. 2016 Jun 7;315(21):2284-91. doi: 10.1001/jama.2016.6458.

    PubMed 27272580

  • Chu SY, Kim SY, Schmid CH, Dietz PM, Callaghan WM, Lau J, Curtis KM. Maternal obesity and risk of cesarean delivery: a meta-analysis. Obes Rev. 2007 Sep;8(5):385-94. doi: 10.1111/j.1467-789X.2007.00397.x.

    PubMed 17716296

  • Weiss JL, Malone FD, Emig D, Ball RH, Nyberg DA, Comstock CH, Saade G, Eddleman K, Carter SM, Craigo SD, Carr SR, D'Alton ME; FASTER Research Consortium. Obesity, obstetric complications and cesarean delivery rate--a population-based screening study. Am J Obstet Gynecol. 2004 Apr;190(4):1091-7. doi: 10.1016/j.ajog.2003.09.058.

    PubMed 15118648

  • Hibbard JU, Gilbert S, Landon MB, Hauth JC, Leveno KJ, Spong CY, Varner MW, Caritis SN, Harper M, Wapner RJ, Sorokin Y, Miodovnik M, Carpenter M, Peaceman AM, O'Sullivan MJ, Sibai BM, Langer O, Thorp JM, Ramin SM, Mercer BM, Gabbe SG; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Trial of labor or repeat cesarean delivery in women with morbid obesity and previous cesarean delivery. Obstet Gynecol. 2006 Jul;108(1):125-33. doi: 10.1097/01.AOG.0000223871.69852.31.

    PubMed 16816066

  • Edwards RK, Cantu J, Cliver S, Biggio JR Jr, Owen J, Tita ATN. The association of maternal obesity with fetal pH and base deficit at cesarean delivery. Obstet Gynecol. 2013 Aug;122(2 Pt 1):262-267. doi: 10.1097/AOG.0b013e31829b1e62.

    PubMed 23969793

  • Vricella LK, Louis JM, Mercer BM, Bolden N. Impact of morbid obesity on epidural anesthesia complications in labor. Am J Obstet Gynecol. 2011 Oct;205(4):370.e1-6. doi: 10.1016/j.ajog.2011.06.085. Epub 2011 Jun 29.

    PubMed 21864821

  • von Ungern-Sternberg BS, Regli A, Bucher E, Reber A, Schneider MC. Impact of spinal anaesthesia and obesity on maternal respiratory function during elective Caesarean section. Anaesthesia. 2004 Aug;59(8):743-9. doi: 10.1111/j.1365-2044.2004.03832.x.

    PubMed 15270963

  • Kelly MC, Fitzpatrick KT, Hill DA. Respiratory effects of spinal anaesthesia for caesarean section. Anaesthesia. 1996 Dec;51(12):1120-2. doi: 10.1111/j.1365-2044.1996.tb15046.x.

    PubMed 9038445

  • Turan OM, Rosenbloom J, Galey JL, Kahntroff SL, Bharadwaj S, Turner SM, Malinow AM. The Relationship between Rostral Retraction of the Pannus and Outcomes at Cesarean Section. Am J Perinatol. 2016 Aug;33(10):951-6. doi: 10.1055/s-0036-1581054. Epub 2016 Apr 21.

    PubMed 27100522

  • Dominguez JE, Krystal AD, Habib AS. Obstructive Sleep Apnea in Pregnant Women: A Review of Pregnancy Outcomes and an Approach to Management. Anesth Analg. 2018 Nov;127(5):1167-1177. doi: 10.1213/ANE.0000000000003335.

    PubMed 29649034

  • Dominguez JE, Street L, Louis J. Management of Obstructive Sleep Apnea in Pregnancy. Obstet Gynecol Clin North Am. 2018 Jun;45(2):233-247. doi: 10.1016/j.ogc.2018.01.001.

    PubMed 29747728

  • MacIntyre NR. Physiologic Effects of Noninvasive Ventilation. Respir Care. 2019 Jun;64(6):617-628. doi: 10.4187/respcare.06635.

    PubMed 31110031

  • Corcione N, Karim H, Mina B, Pisano A, Dikmen Y, Kondili E, Nicolini A, Fiorentino G, Caldeira V, Ubeda A, Papadakos P, Wittenstein J, Singha S, Sovani M, Panda C, Tani C, Khatib M, Perren A, Ho K, Esquinas A. Non-invasive ventilation during surgery under neuraxial anaesthesia: a pathophysiological perspective on application and benefits and a systematic literature review. Anaesthesiol Intensive Ther. 2019;51(4):289-298. doi: 10.5114/ait.2019.88572.

    PubMed 31617693

  • Erdogan G, Okyay DZ, Yurtlu S, Hanci V, Ayoglu H, Koksal B, Turan IO. Non-invasive mechanical ventilation with spinal anesthesia for cesarean delivery. Int J Obstet Anesth. 2010 Oct;19(4):438-40. doi: 10.1016/j.ijoa.2010.04.005. Epub 2010 Aug 10.

    PubMed 20702082

  • Polin CM, Hale B, Mauritz AA, Habib AS, Jones CA, Strouch ZY, Dominguez JE. Anesthetic management of super-morbidly obese parturients for cesarean delivery with a double neuraxial catheter technique: a case series. Int J Obstet Anesth. 2015 Aug;24(3):276-80. doi: 10.1016/j.ijoa.2015.04.001. Epub 2015 Apr 8.

    PubMed 25936783

Questions about this trial

What is this clinical trial studying?

A study testing CPAP in people with Morbid Obesity and Cesarean Delivery Affecting Fetus, run by Eastern Virginia Medical School 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 7 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 Sep 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 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 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?

Umbilical Cord Arterial pH (time frame: At delivery). 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 NCT04993651, which also lists 21 linked publications.

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 Sep 2024.

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