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NCT Number: NCT06181396

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rambam medical health campus

Haifa, 31999, Israel

Location status: Recruiting

Location contact

Gal Bachar, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxytocin

Drug

Native oxytocin analog

Other names: Pitocin

Primary outcomes

  1. Mode of delivery

    Time frame: Delivery

    Vaginal or instrumental or cesarean

Secondary outcomes

  1. 2nd stage duration

    Time frame: Delivery

    Minutes

  2. intrapartum fever

    Time frame: Delivery or 48 hours postpartum

    Rate of chorioamnionitis

  3. Meconium stain

    Time frame: Delivery

    Rate

  4. Postpartum hemorrhage

    Time frame: Delivery

    more than 500 ml following vaginal delivery or more than 1000 ml at cesarean delivery

  5. FHR decelerations

    Time frame: Delivery

    Variable or Late Decelerations viewed by the physician according to external fetal monitor.

  6. Neonatal pH

    Time frame: Delivery

    Umbilical cord pH

  7. Neonatal Apgar score

    Time frame: Delivery

    5 minutues Apgar score

  8. Admission of the neonate to neonatal intensive care unit

    Time frame: Immediate postpartum, up to 5 days.

    Admission of the neonate to neonatal intensive care unit

Study contacts

Contact information is provided by the study sponsor or research team.

Gal Bachar, MD

CONTACT

[email protected]

+97247771449

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Dec 26, 2023
Registry last updated
Dec 26, 2023

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.

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