Time of Oxytocin Initiation at 2nd Stage of Labor and Adverse Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oxytocin.
- Who it may be relevant to
- Registry conditions: Delivery Complication, Cesarean Delivery Affecting Fetus. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Association Between Time of Oxytocin Initiation at 2nd Stage of Labor and Adverse Outcomes
Overview
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
- Drug Oxytocin
Native oxytocin analog
Primary outcome measures
- Mode of delivery [Time frame: Delivery]
Secondary outcome measures (8)
- 2nd stage duration [Time frame: Delivery]
- intrapartum fever [Time frame: Delivery or 48 hours postpartum]
- Meconium stain [Time frame: Delivery]
- Postpartum hemorrhage [Time frame: Delivery]
- FHR decelerations [Time frame: Delivery]
- Neonatal pH [Time frame: Delivery]
- Neonatal Apgar score [Time frame: Delivery]
- Admission of the neonate to neonatal intensive care unit [Time frame: Immediate postpartum, up to 5 days.]
Eligibility criteria
Inclusion criteria
- Singleton pregnancy
- Maternal age ≥ 18 years' old
- Oxytocin administration initiated or renewed during second stage of labor
Exclusion criteria
- Maternal age < 18 years' old
- Multiple gestation pregnancy
- Known fetal malformations
- Uterine scar
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Israel · 1 center
- Rambam medical health campus — Haifa
Identifiers
NCT: NCT06181396 · 0061-22-RMB