Comparison of Low-dose and High-dose Oxytocin Regimens for Labor Augmentation

NCT02487797 | Completed Phase 4 Results DMC

• 1 other identifier: STU00201148
• Study Type: interventional
• Target: 1,003
• Locations: 1 country
• Sites: 1

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.

Conditions

Dystocia

Outcome Measures

Primary Outcomes (1)

• Number of Participants Delivered by Cesarean

  Number of participants delivered by cesarean section

  At time of delivery

Secondary Outcomes (9)

• Labor Augmentation Duration

  Number of hours from randomization to delivery

• Number of Participants With Postpartum Hemorrhage

  From date of delivery to date of hospital discharge, an expected average of 3 days

• Number of Participants With Intrapartum Chorioamnionitis

  From time of labor admission to time of delivery, an expected average of 24 to 48 hours

• Number of Participants With Postpartum Endometritis

  From time of delivery to time of hospital discharge, an expected average of 3 days

• Number of Participants Whose Offspring Experiences a Perinatal Death

  Study enrollment to delivery (if intrapartum stillbirth) or 28 days of life (if liveborn)

Study Arms (2)

High dose oxytocin regimen

EXPERIMENTAL

The oxytocin solution will be prepared using 90 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 6 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 6 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.

Drug: Oxytocin; Other: Sodium Chloride 0.9%

Low dose oxytocin regimen

ACTIVE COMPARATOR

The oxytocin solution will be prepared using 30 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 2 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 2 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.

Drug: Oxytocin; Other: Sodium Chloride 0.9%

Interventions

Oxytocin DRUG

Also known as: Pitocin

High dose oxytocin regimen; Low dose oxytocin regimen

Sodium Chloride 0.9% OTHER

Also known as: Normal Saline

High dose oxytocin regimen; Low dose oxytocin regimen

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

• Son M, Roy A, Grobman WA, Miller ES, Dude A, Peaceman AM, Stetson B. Maximum Dose Rate of Intrapartum Oxytocin Infusion and Associated Obstetric and Perinatal Outcomes. Obstet Gynecol. 2023 Feb 1;141(2):379-386. doi: 10.1097/AOG.0000000000005058. Epub 2023 Jan 4.

  PMID: 36649339 DERIVED

• 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.

  PMID: 33957657 DERIVED

MeSH Terms

Conditions

Dystocia

Interventions

Oxytocin; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Moeun Son
• Organization: Northwestern University, Yale University

moeun.son@yale.edu

475-414-5328

Study Officials

• Moeun Son, MD, MSCI

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Alan Peaceman, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Obstetrics and Gynecology - Maternal Fetal Medicine

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: July 1, 2015
• Study Start: September 28, 2015
• Primary Completion: September 1, 2020
• Study Completion: September 28, 2020
• Last Updated: February 11, 2022
• Results First Posted: February 11, 2022

Record last verified: 2022-02

Locations

US (1)