Clinical trial NCT06181396: Time of Oxytocin Initiation at 2nd Stage of Labor and Adverse Outcomes
Official title: Association Between Time of Oxytocin Initiation at 2nd Stage of Labor and Adverse Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Delivery Complication
Cesarean Delivery Affecting Fetus
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial of singleton gestations receiving oxytocin during the second stage of labor at a single tertiary medical center. Women will be randomly allocated to one of two groups - immediate initiation of oxytocin at full dilation versus delayed oxytocin initiation following one hour of full dilation.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mode of delivery
timeFrame: Delivery
Secondary outcomes:
measure: 2nd stage duration
timeFrame: Delivery
measure: intrapartum fever
timeFrame: Delivery or 48 hours postpartum
measure: Meconium stain
timeFrame: Delivery
measure: Postpartum hemorrhage
timeFrame: Delivery
measure: FHR decelerations
timeFrame: Delivery
measure: Neonatal pH
timeFrame: Delivery
measure: Neonatal Apgar score
timeFrame: Delivery
measure: Admission of the neonate to neonatal intensive care unit
timeFrame: Immediate postpartum, up to 5 days.
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam medical health campus
Study officials:
References: