Time of Oxytocin Initiation at 2nd Stage of Labor and Adverse Outcomes

Association Between Time of Oxytocin Initiation at 2nd Stage of Labor and Adverse Outcomes

Early oxytocin administration at the 2nd stage of labor is associated with a higher rate of vaginal delivery, shorter second stage duration, and fewer adverse maternal and neonatal outcomes.

Study Overview

• Status: Recruiting
• Conditions: Cesarean Delivery Affecting Fetus; Delivery Complication
• Intervention / Treatment: Drug: Oxytocin

Detailed Description

Cesarean delivery (CD) is one of the most common surgeries performed worldwide. In the last few decades, its rate has steadily increased worldwide, leading to an increase in maternal morbidity and mortality compared to vaginal delivery (VD)1. In 2014, the American College of Obstetricians and Gynecologists (ACOG) and Society for Maternal Fetal Medicine (SMFM) published an Obstetric Care Consensus for safe prevention of primary cesarean delivery, allowing an additional hour of pushing during the 2nd stage of labor for both nulliparous and multiparous women before diagnosing prolonged 2nd of labor2-4.

Prolonged 2nd stage is especially common among nulliparous women5, and is defined as more than three hours of pushing6, or four hours for women with a regional anesthesia. Prolonged 2nd stage has been shown to be associated with maternal adverse outcomes, such as assisted-vaginal delivery, CD, and postpartum hemorrhage (PPH)7,8, and neonatal adverse outcomes such as low 5-minute Apgar score, and NICU admissions9.

Oxytocin is the primary and the most widely used pharmacological agent for induction and augmentation of labor10. Administrating oxytocin during labor is a common practice and is used to intensify contractions and decrease the chances of a non-progressive labor and associated adverse outcomes11,12. Despite its extensive use, there are several protocols which varies between different countries and obstetric wards. Likewise, there is no consensus regarding the duration or dosage of oxytocin infusion during labor, and especially during the 2nd stage of labor13.

The study will assess the optimal time initiation of Oxytocin during the 2nd stage of labor, and its association to mode of delivery, and adverse maternal and neonatal outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gal Bachar, MD; Phone Number: +97247771449; Email: g_bachar@rambam.health.gov.il

Study Locations

• Israel
  • Haifa, Israel, 31999
    • Recruiting
    • Rambam medical health campus
    • Contact: Gal Bachar, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Singleton pregnancy
2. Maternal age ≥ 18 years' old
3. Oxytocin administration initiated or renewed during second stage of labor

Exclusion Criteria:

1. Maternal age < 18 years' old
2. Multiple gestation pregnancy
3. Known fetal malformations
4. Uterine scar

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate oxytocin; This arm will receive oxytocin when entering 2nd stage (full dilation)	Drug: Oxytocin; Native oxytocin analog; Other Names: Pitocin
Other: Delayed oxytocin; This arm will receive oxytocin one hour after entering 2nd stage (full dilation)	Drug: Oxytocin; Native oxytocin analog; Other Names: Pitocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mode of delivery	Vaginal or instrumental or cesarean	Delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2nd stage duration	Minutes	Delivery
intrapartum fever	Rate of chorioamnionitis	Delivery or 48 hours postpartum
Meconium stain	Rate	Delivery
Postpartum hemorrhage	more than 500 ml following vaginal delivery or more than 1000 ml at cesarean delivery	Delivery
FHR decelerations	Variable or Late Decelerations viewed by the physician according to external fetal monitor.	Delivery
Neonatal pH	Umbilical cord pH	Delivery
Neonatal Apgar score	5 minutues Apgar score	Delivery
Admission of the neonate to neonatal intensive care unit	Admission of the neonate to neonatal intensive care unit	Immediate postpartum, up to 5 days.

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: September 10, 2023
• First Submitted That Met QC Criteria: December 22, 2023
• First Posted (Actual): December 26, 2023

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: 0061-22-RMB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No