Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06181396
Other study ID # 0061-22-RMB
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2023
Est. completion date October 2026

Study information

Verified date December 2023
Source Rambam Health Care Campus
Contact Gal Bachar, MD
Phone +97247771449
Email g_bachar@rambam.health.gov.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date October 2026
Est. primary completion date October 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Oxytocin
Native oxytocin analog

Locations

Country Name City State
Israel Rambam medical health campus Haifa

Sponsors (1)

Lead Sponsor Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mode of delivery Vaginal or instrumental or cesarean Delivery
Secondary 2nd stage duration Minutes Delivery
Secondary intrapartum fever Rate of chorioamnionitis Delivery or 48 hours postpartum
Secondary Meconium stain Rate Delivery
Secondary Postpartum hemorrhage more than 500 ml following vaginal delivery or more than 1000 ml at cesarean delivery Delivery
Secondary FHR decelerations Variable or Late Decelerations viewed by the physician according to external fetal monitor. Delivery
Secondary Neonatal pH Umbilical cord pH Delivery
Secondary Neonatal Apgar score 5 minutues Apgar score Delivery
Secondary Admission of the neonate to neonatal intensive care unit Admission of the neonate to neonatal intensive care unit Immediate postpartum, up to 5 days.
See also
  Status Clinical Trial Phase
Completed NCT03730220 - The Norwegian Induction Project: a Pilot for a Prospective National Audit
Completed NCT05047211 - Intravenous Iron vs. Oral Iron Supplementation for Postpartum Anemia Phase 4
Completed NCT04181840 - Impedance Spectroscopy for Obstetric Anal Sphincter Injuries Detection N/A
Not yet recruiting NCT05080309 - Effect of Oral Carbohydrate Intake > 44kCal Per Hour During Labour on the Rate of Instrumental Vaginal Delivery N/A
Completed NCT06002997 - Periodontal Status and Pregnancy or Delivery Complications in Type 1 Diabetes Mellitus Pregnant Women
Completed NCT04903977 - Detection of Obstetric Anal Sphincter Injuries With ONIRY Device N/A
Recruiting NCT05345600 - MILTA vs Placebo Use Comparison for the Management of Pain Related to Perineal Scars Following Delivery N/A
Completed NCT05605626 - Learning Skills in Young Specialists and Residents in Operative Vaginal Delivery Using Simulator Models
Not yet recruiting NCT06411158 - Training for Urinary Leakage Improvement After Pregnancy N/A
Not yet recruiting NCT05845879 - Obstetrical Outcomes for Planned Deliveries in a French Birth Center
Completed NCT05579808 - Effect of Epidural Analgesia on Labour, Neonatal and Maternal Outcomes.
Completed NCT03161184 - Impact of a Smartphone Intervention on Tanzanian Women's Childbirth Location N/A
Recruiting NCT04159857 - Hand Forceps vs. Conventional One-hand Technique for Fetal Head Extraction During Cesarean Section N/A
Recruiting NCT04685668 - The PartoMa Project: Enabling Best Post Possible Childbirth Care in Tanzania. N/A
Completed NCT04796155 - Intrapartum Ultrasonography in Labour Arrest
Completed NCT05258786 - Pre-labor Ultrasound as a Visual Biofeedback Device for Maternal Pushing Education N/A
Completed NCT04664335 - Impact of Endometriosis on Pregnancy and Delivery - a Retrospective Cohort Study
Not yet recruiting NCT05079061 - A Trial of Sublingual Misoprostol to Reduce Primary Postpartum Haemorrhage After Vaginal Delivery Phase 4