Comparison of Low-dose and High-dose Oxytocin Regimens for Labor Augmentation
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 7/22/2018 |
| Start Date: | September 28, 2015 |
| End Date: | September 2019 |
| Contact: | Moeun Son, MD |
| Email: | moeun.son@northwestern.edu |
| Phone: | 312-472-4647 |
A Randomized Double Blind Clinical Trial Comparing Oxytocin Low-dose and High-dose Regimens for Labor Augmentation
Oxytocin is a medication that is often used to strengthen contractions to overcome delayed
labor progress. The primary aim of this study is to determine whether receiving a higher dose
of oxytocin lowers the chance of needing a cesarean section when compared to a lower dose of
oxytocin. Other aims include examining the relationship between dose of oxytocin regimen and
length of labor, postpartum hemorrhage, intrauterine infection, umbilical cord gas, neonatal
Apgar score <5 at 5 minutes, and need for neonatal intensive care.
labor progress. The primary aim of this study is to determine whether receiving a higher dose
of oxytocin lowers the chance of needing a cesarean section when compared to a lower dose of
oxytocin. Other aims include examining the relationship between dose of oxytocin regimen and
length of labor, postpartum hemorrhage, intrauterine infection, umbilical cord gas, neonatal
Apgar score <5 at 5 minutes, and need for neonatal intensive care.
This randomized double blind clinical trial of consenting nulliparous women in spontaneous
labor who require oxytocin for labor augmentation seeks to determine whether use of a high
dose oxytocin regimen improves obstetric outcomes when compared with a low dose oxytocin
regimen, in a manner that is safe for both mother and neonate.
This project will include 1002 women recruited from the obstetrical service at Prentice
Women's Hospital. Women will be included if they are at least 36 weeks gestation, have a
singleton pregnancy, and have been diagnosed with spontaneous labor or spontaneous rupture of
membranes. Women will be exposed to oxytocin for the indication of labor augmentation at the
discretion of their obstetric provider.
Women will be randomized with equal probability to intervention group using a fixed
allocation procedure. To maintain a double blind design, the Prentice Women's Hospital
pharmacy will carry out the randomization of oxytocin solutions according to the random
assignment so that neither the women or their care providers nor the investigators will know
the identity of the intervention assignment. The low-dose oxytocin regimen group will receive
a starting oxytocin regimen concentration rate of 2 milliunits/minute that can be increased
at increments of 2 milliunits/minute, as per the discretion of their obstetric provider. The
high-dose oxytocin regimen group will receive a starting oxytocin regimen concentration rate
of 6 milliunits/minute that can be increased at increments of 6 milliunits/minute, as per the
discretion of their obstetric provider.
Once the women are enrolled, randomized, and in receipt of their assigned interventions,
further clinical management will be left to the discretion of each woman's obstetric
provider.
Prior to discharge from the hospital, baseline demographic and clinical data will be obtained
via chart review.
labor who require oxytocin for labor augmentation seeks to determine whether use of a high
dose oxytocin regimen improves obstetric outcomes when compared with a low dose oxytocin
regimen, in a manner that is safe for both mother and neonate.
This project will include 1002 women recruited from the obstetrical service at Prentice
Women's Hospital. Women will be included if they are at least 36 weeks gestation, have a
singleton pregnancy, and have been diagnosed with spontaneous labor or spontaneous rupture of
membranes. Women will be exposed to oxytocin for the indication of labor augmentation at the
discretion of their obstetric provider.
Women will be randomized with equal probability to intervention group using a fixed
allocation procedure. To maintain a double blind design, the Prentice Women's Hospital
pharmacy will carry out the randomization of oxytocin solutions according to the random
assignment so that neither the women or their care providers nor the investigators will know
the identity of the intervention assignment. The low-dose oxytocin regimen group will receive
a starting oxytocin regimen concentration rate of 2 milliunits/minute that can be increased
at increments of 2 milliunits/minute, as per the discretion of their obstetric provider. The
high-dose oxytocin regimen group will receive a starting oxytocin regimen concentration rate
of 6 milliunits/minute that can be increased at increments of 6 milliunits/minute, as per the
discretion of their obstetric provider.
Once the women are enrolled, randomized, and in receipt of their assigned interventions,
further clinical management will be left to the discretion of each woman's obstetric
provider.
Prior to discharge from the hospital, baseline demographic and clinical data will be obtained
via chart review.
Inclusion Criteria:
- Able to give informed written consent
- Age 18-45 years
- Nulliparous
- Pregnant with a singleton gestation that is equal to or greater than 36 weeks
- Diagnosed with at least 6 regular uterine contractions in an observation period of no
more than 60 minutes and at least one of the following: spontaneous rupture of
membranes, OR cervix greater than or equal to 3 centimeters dilated OR cervix at least
80% effaced.
- The participant's attending obstetric physician or midwife has determined that the
participant needs administration of oxytocin infusion for labor augmentation. Labor
augmentation will be defined as stimulation of uterine contractions when spontaneous
contractions have failed to result in progressive cervical dilation of descent of
fetus.
Exclusion Criteria:
- Women not meeting the above criteria
- History of prior cesarean section or uterine surgery
- Fetus in non-cephalic presentation
- Participant is undergoing labor induction (i.e. cervical ripening)
- Non-English speaking
We found this trial at
1
site
251 E Huron St
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 926-2000
Phone: 312-472-4647
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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