Evaluation of Compensatory Reserve in Obstetrical Patients

Status Enrolling by invitation

Clinical Trial Summary

Using a pulse oximeter, the investigators have developed an algorithm that assesses central volume status. Pregnant women present some unique opportunities for us to investigate the algorithm under different circumstances. The investigators want to specifically investigate an algorithm with women who undergo regional anesthesia such as epidurals, with women who undergo fetal surgery, and with women in labor and giving birth (and the recovery time following delivery). This will help the investigators understand the central volume status changes that women experience in these unique circumstances. The Investigators also want to put the pulse oximeter on the fetal hand when possible during certain maternal fetal interventions. The Investigators would like to examine the algorithm with data from the fetuses.

Clinical Trial Description

The Investigators hypothesize that the Compensatory Reserve Index (CRI) algorithm will help to guide fluid management in women undergoing regional anesthesia, giving birth, and/or undergoing maternal fetal intervention surgery. Specific aims: Collect noninvasive physiological waveform data from patients undergoing regional anesthesia and either fetal intervention surgery or labor and delivery at Children's Hospital Colorado in order to: 1. Determine how regional anesthesia influences CRI algorithm calculations 2. Determine if the CRI algorithm is able to detect changes in central volume status associated with fetal surgery. 3. Determine if the CRI algorithm is able to detect changes in central volume status associated with labor and childbirth specifically at the time of delivery, when most women experience some amount of bleeding. 4. Examine CRI associated with induction of regional anesthesia and determine if there is a minimal CRI below which one can expect hypotension and if there is a trend down in CRI following induction of regional anesthesia that could anticipate/predict hypotension. 5. Determine if there is a correlation between fetal heart rate abnormalities and CRI. 6. Examine CRI associated with fetal monitoring. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02408588
Study type	Observational
Source	University of Colorado, Denver
Contact
Status	Enrolling by invitation
Phase
Start date	February 1, 2015
Completion date	May 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05708482` - Sling and Swing Positions to Pregnant Women	N/A
Terminated	`NCT01320995` - Perineal Echography in the Delivery Room for the Detection of Anal Lesions	N/A
Recruiting	`NCT04603859` - When to INDuce for OverWeight? (WINDOW)	N/A
Completed	`NCT01131260` - Fetal ST Segment and T Wave Analysis in Labor	N/A
Completed	`NCT01164657` - A Swedish Trial of Birth on a Birthing Seat	N/A
Completed	`NCT03441243` - Evaluation of the Psychological Consequences of Complicated Childbirth
Completed	`NCT00323401` - The Influence of Antenatal Classes on Pregnancy, Birth and Parenthood	N/A
Completed	`NCT03490682` - Gastric Emptying During the Labour	N/A
Completed	`NCT03890276` - Field Study of Health Worker Training on Helping Mothers Survive Module 'Essential Care for Labor & Birth' in Zanzibar	N/A
Completed	`NCT02870712` - Randomized Controlled Trial of the Effectiveness of Perineal Pain and Security of the Suture Led by the Result of Hemostasis Versus Manual Compression Routine Suture Perineal Tears of First Degree During Childbirth	N/A
Not yet recruiting	`NCT02363036` - The Shift From Monocytes to Neutrophils in Blood Samples of Women in Labor	N/A
Not yet recruiting	`NCT02361853` - The Role of Immature Myeloid Cells, Monocytes, Dentritic Cells and Neutrophils in Human Pregnancies as Markers for Mature Pregnancy and Spontaneous Labor	N/A
Not yet recruiting	`NCT02493192` - Birth Ball Versus Meperidine and Haloperidol Injection for Pain Relief During First Stage of Labour	Phase 4
Completed	`NCT04432675` - Effects of Crystal Solution and Colloid Solution on Mother and Fetus	Phase 4
Recruiting	`NCT01051726` - Effects of Aromatherapy on Childbirth	Phase 2
Completed	`NCT05820958` - Intensified Tactile Contact With a Newborn Andt Emotional Transformation of the Mother	N/A
Completed	`NCT06069596` - Evaluation of the Effectiveness of Obstetric Lubricant Gel in Labor in Nulliparous and Primiparous Women: A Randomized Controlled Study	Phase 4
Recruiting	`NCT06380400` - The Effect of Foot Bath on Birth Pain and Birth Comfort	N/A
Not yet recruiting	`NCT04657107` - The Efficacy and Safety of S-ketamine in Elective Cesarean Section	N/A
Completed	`NCT02823418` - Neuraxial Labor Analgesia and the Incidence of Postpartum Depression

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.