Clinical trial NCT02487797: Comparison of Low-dose and High-dose Oxytocin Regimens for Labor Augmentation
Official title: A Randomized Double Blind Clinical Trial Comparing Oxytocin Low-dose and High-dose Regimens for Labor Augmentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dystocia
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2015-07-01
Enrollment: 1003
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Able to give informed written consent
* Age 18-45 years
* Nulliparous
* Pregnant with a live 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

Primary outcomes:
measure: Number of Participants Delivered by Cesarean
timeFrame: At time of delivery
Secondary outcomes:
measure: Labor Augmentation Duration
timeFrame: Number of hours from randomization to delivery
measure: Number of Participants With Postpartum Hemorrhage
timeFrame: From date of delivery to date of hospital discharge, an expected average of 3 days
measure: Number of Participants With Intrapartum Chorioamnionitis
timeFrame: From time of labor admission to time of delivery, an expected average of 24 to 48 hours
measure: Number of Participants With Postpartum Endometritis
timeFrame: From time of delivery to time of hospital discharge, an expected average of 3 days
measure: Number of Participants Whose Offspring Experiences a Perinatal Death
timeFrame: Study enrollment to delivery (if intrapartum stillbirth) or 28 days of life (if liveborn)
measure: Number of Participants With Umbilical Cord Acidemia
timeFrame: At time of delivery
measure: Neonatal Apgar Score of Less Than 3 at 5 Minutes of Life
timeFrame: Delivery through 5 minutes of life
measure: Admission to Neonatal Intensive Care Unit
timeFrame: Delivery to 28 days of life
measure: Number of Participants Whose Neonates Experience a Composite of Severe Neonatal Morbidity and Perinatal Mortality
timeFrame: Delivery to 28 days of life
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Moeun Son, MD, MSCI
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Alan Peaceman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Son M, Roy A, Stetson BT, Grady NT, Vanecko MC, Bond N, Swanson K, Grobman WA, Miller ES, Peaceman AM. High-Dose Compared With Standard-Dose Oxytocin Regimens to Augment Labor in Nulliparous Women: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jun 1;137(6):991-998. doi: 10.1097/AOG.0000000000004399.