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Completed

NCT Number: NCT04993651

Effect of CPAP on Fetal pH at Scheduled C-section 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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Norfolk, Virginia, 23507, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPAP

Device

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.

Other names: Continuous Positive Airway Pressure

Primary outcomes

  1. Umbilical Cord Arterial pH

    Time frame: At delivery

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

Secondary outcomes

  1. Patient satisfaction with use of CPAP

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

    Survey will be used to determine patient experience and satisfaction

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

    Time frame: At time of uterine incision

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

  3. Effect of maternal CPAP use on neonatal Apgar scores

    Time frame: At delivery

    Apgar scores will be compared between 2 groups

  4. Effect of maternal CPAP use on composite neonatal outcome

    Time frame: At delivery

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

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

    Time frame: At delivery

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

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

    Time frame: At delivery

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

Sponsors and collaborators

Lead sponsor

Eastern Virginia Medical School

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 6, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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