Rambam medical health campus
Haifa, 31999, Israel
Location status: Recruiting
Location contact
Gal Bachar, MD
CONTACT
NCT Number: NCT06181396
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Haifa, 31999, Israel
Location status: Recruiting
Gal Bachar, MD
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Native oxytocin analog
Other names: Pitocin
Time frame: Delivery
Vaginal or instrumental or cesarean
Time frame: Delivery
Minutes
Time frame: Delivery or 48 hours postpartum
Rate of chorioamnionitis
Time frame: Delivery
Rate
Time frame: Delivery
more than 500 ml following vaginal delivery or more than 1000 ml at cesarean delivery
Time frame: Delivery
Variable or Late Decelerations viewed by the physician according to external fetal monitor.
Time frame: Delivery
Umbilical cord pH
Time frame: Delivery
5 minutues Apgar score
Time frame: Immediate postpartum, up to 5 days.
Admission of the neonate to neonatal intensive care unit
Contact information is provided by the study sponsor or research team.
Rambam Health Care Campus
Other
Association Between Time of Oxytocin Initiation at 2nd Stage of Labor and Adverse Outcomes
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.
Published trials that share one or more normalized conditions with this study.
NCT06693817
Apnea of Newborn, Asphyxia Neonatorum
Londrina, Paraná, Brazil
View Trial DetailsNCT06411158
Behavior, Behavioral Symptoms
San Diego, California, United States
View Trial DetailsNCT07278037
Cesarean Section Complications, Delivery Complication
Bangkoknoi, Bangkok, Thailand
View Trial DetailsNCT05080309
Delivery Complication, Labor Long
Caen, France
View Trial Details