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

Delivery Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06181396
• Other study ID #: 0061-22-RMB
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: October 2026

Study information

• Verified date: December 2023
• Source: Rambam Health Care Campus
• Contact: Gal Bachar, MD
• Phone: +97247771449
• Email: g_bachar[@]rambam.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Delivery Affecting Fetus
• Delivery Complication

Intervention

Drug:
• Oxytocin
Native oxytocin analog

Locations

Country	Name	City	State
Israel	Rambam medical health campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

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