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NCT Number: NCT04303702

The Role of Oxytocin in the Second Stage of Labor

This is a randomized controlled trial investigating the utility of oxytocin administration in the second stage of labor.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Nandini Raghuraman, MD MS

CONTACT

[email protected]

918-691-7389

About this study

Oxytocin is widely used on Labor and Delivery units throughout the world.Laboring patients are most likely to initiate oxytocin in the first stage of labor. Among those who receive oxytocin, first stage initiation is far more common than second stage initiation. The goal of first stage administration is to increase uterine contractility and cause cervical dilation, particularly in patients who have epidural analgesia. Once complete cervical dilation has been achieved, most providers choose to continue oxytocin in the second stage of labor for the theoretic benefit of increased expulsion "power" while pushing. This practice is currently not evidence-based as the limited data thus far suggests no difference in operative deliveries with the use of oxytocin augmentation in general. The benefits and risk of oxytocin continuation in the second stage of labor is unknown. Oxytocin administration is associated with the risk of uterine tachysystole, postpartum hemorrhage,and maternal hyponatremia. These risks call for a closer look at prolonged oxytocin use past the first stage of labor. This is a randomized controlled trial investigating the utility of oxytocin administration in the second stage of labor.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Nulliparous pregnant women >/= 37 weeks gestation
  • Singleton pregnancies
  • Admission for induction of labor or spontaneous labor

Exclusion criteria

  • Multiple gestations
  • Multiparous patients
  • Patients with major fetal anomalies
  • Not on oxytocin at the time of complete cervical dilation
  • Patients with fetal head visible at the perineum on diagnosis of complete cervical dilation
  • Maternal medical condition that prohibits prolonged second stage

Treatment and study plan

Continue Oxytocin

Drug

The administration and titration of oxytocin for labor augmentation is per a hospital based protocol. To summarize, oxytocin is initiated intravenously at 2 milliunits/minute and increased by 2 milliunits/minute every 20 minutes until an adequate contraction pattern is attained or a maximum of 40 millunits/minute has been achieved. This protocol for titration and administration will be applied in this study to the oxytocin group. The intravenous pumps on Labor and Delivery have automated functions for intravenous administration of oxytocin that is milliunit-based and the same routine pumps will be used in this study. The study bag will be administered per current oxytocin protocol. Since patients will already be on oxytocin at time of randomization, their current bag of oxytocin will be continued by the primary provider at a rate of their discretion.

Discontinue Oxytocin

Other

Patients will have their oxytocin discontinued in the second stage of labor. The patient will receive routine maintenance IV fluids per the discretion of the provider.

Primary outcomes

  1. Second stage duration

    Time frame: During admission for delivery

    Time interval from complete cervical dilation to delivery of fetus

Secondary outcomes

  1. Rate of operative delivery

    Time frame: During admision for delivery

    Rate of cesarean section and operative vaginal delivery including forcep or vacuum

  2. Rate of Postpartum hemorrhage

    Time frame: During admission for delivery

    Estimated blood loss >500 mL for vaginal delivery and >1000 mL for cesarean delivery

  3. Estimated blood loss

    Time frame: During admission for delivery

    Estimated blood loss at time of delivery (mL)

  4. Rate of chorioamnionitis during the second stage of labor

    Time frame: During admission for delivery

    Chorioamnionitis diagnosed at discretion of primary provider during the second stage of labor

  5. Rate of endometritis

    Time frame: During admission for delivery

    Postpartum endometritis as diagnosed by primary provider

  6. Rate of severe perineal laceration

    Time frame: During admission for delivery

    3rd or 4th degree perineal laceration

  7. Rate of composite neonatal morbidity

    Time frame: During admission for delivery

    1 or more of the following: death, birth injury, umbilical artery acidosis, respiratory distress, transient tachypnea, meconium aspiration with pulmonary hypertension, hypoxic-ischemic encephalopathy, hypoglycemia, hypothermia treatment, or suspected neonatal sepsis.

Study contacts

Contact information is provided by the study sponsor or research team.

Nandini Raghuraman, MD MSCI

CONTACT

[email protected]

9186917389

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • University of Michigan

Registry information

Official study title

Role of Oxytocin in the Second Stage of Labor: a Randomized Controlled Trial (The ROSSoL Trial)

Acronym: ROSSoL

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 11, 2020
Registry last updated
Jan 5, 2026

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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