Cesarean Delivery Affecting Fetus, Delivery Complication
Conditions
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.
Interventions
DRUGOxytocin
Native oxytocin analog
Sponsors
Rambam Health Care Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mode of delivery | Delivery | Vaginal or instrumental or cesarean |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| intrapartum fever | Delivery or 48 hours postpartum | Rate of chorioamnionitis |
| Meconium stain | Delivery | Rate |
| Postpartum hemorrhage | Delivery | more than 500 ml following vaginal delivery or more than 1000 ml at cesarean delivery |
| 2nd stage duration | Delivery | Minutes |
| Neonatal pH | Delivery | Umbilical cord pH |
| Neonatal Apgar score | Delivery | 5 minutues Apgar score |
| Admission of the neonate to neonatal intensive care unit | Immediate postpartum, up to 5 days. | Admission of the neonate to neonatal intensive care unit |
| FHR decelerations | Delivery | Variable or Late Decelerations viewed by the physician according to external fetal monitor. |
Countries
Israel
Contacts
Primary ContactGal Bachar, MD
Outcome results
None listed