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

Morbid Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04993651
• Other study ID #: CPAP on Fetal pH
• Status: Recruiting
• Phase: N/A
• Start date: October 11, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: June 2021
• Source: Eastern Virginia Medical School
• Contact: Kristin Ayers, MPH
• Phone: 7574460579
• Email: ayerskl[@]evms.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cesarean Delivery Affecting Fetus
• Morbid Obesity
• Obesity, Morbid

Intervention

Device:
• CPAP
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.

Locations

Country	Name	City	State
United States	Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Eastern Virginia Medical School	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Virginia Medical School

Country where clinical trial is conducted

United States, 

References & Publications (20)

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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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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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. — View Citation

Johansson S, Sandström A, Cnattingius S. Maternal overweight and obesity increase the risk of fetal acidosis during labor. J Perinatol. 2018 Sep;38(9):1144-1150. doi: 10.1038/s41372-018-0144-5. Epub 2018 Jun 19. — View Citation

Kelly MC, Fitzpatrick KT, Hill DA. Respiratory effects of spinal anaesthesia for caesarean section. Anaesthesia. 1996 Dec;51(12):1120-2. — View Citation

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

Pearson F, Batterham AM, Cope S. The STOP-Bang Questionnaire as a Screening Tool for Obstructive Sleep Apnea in Pregnancy. J Clin Sleep Med. 2019 May 15;15(5):705-710. doi: 10.5664/jcsm.7754. — View Citation

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. — View Citation

Simon VB, Fong A, Nageotte MP. Supplemental Oxygen Study: A Randomized Controlled Study on the Effect of Maternal Oxygen Supplementation during Planned Cesarean Delivery on Umbilical Cord Gases. Am J Perinatol. 2018 Jan;35(1):84-89. doi: 10.1055/s-0037-1606184. Epub 2017 Aug 24. — View Citation

Skiöld B, Petersson G, Ahlberg M, Stephansson O, Johansson S. Population-based reference curve for umbilical cord arterial pH in infants born at 28 to 42 weeks. J Perinatol. 2017 Mar;37(3):254-259. doi: 10.1038/jp.2016.207. Epub 2016 Dec 1. — View Citation

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. — View Citation

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. — View Citation

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* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Umbilical Cord Arterial pH	We hypothesize that neonates born to mothers wearing CPAP during the cesarean section will have a higher umbilical artery pH.	At delivery
Secondary	Patient satisfaction with use of CPAP	Survey will be used to determine patient experience and satisfaction	Within 4 days following delivery (prior to discharge from hospital)
Secondary	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	At time of uterine incision
Secondary	Effect of maternal CPAP use on neonatal Apgar scores	Apgar scores will be compared between 2 groups	At delivery
Secondary	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	At delivery
Secondary	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	At delivery
Secondary	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	At delivery