NCT06181396

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress87%
Oct 2023Oct 2026

First Submitted

Initial submission to the registry

September 10, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 26, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

December 26, 2023

Status Verified

December 1, 2023

Enrollment Period

2 years

First QC Date

September 10, 2023

Last Update Submit

December 22, 2023

Conditions

Delivery ComplicationCesarean Delivery Affecting Fetus

Outcome Measures

Primary Outcomes (1)

  • Mode of delivery

    Vaginal or instrumental or cesarean

    Delivery

Secondary Outcomes (8)

  • 2nd stage duration

    Delivery

  • intrapartum fever

    Delivery or 48 hours postpartum

  • Meconium stain

    Delivery

  • Postpartum hemorrhage

    Delivery

  • FHR decelerations

    Delivery

  • +3 more secondary outcomes

Study Arms (2)

Immediate oxytocin

EXPERIMENTAL

This arm will receive oxytocin when entering 2nd stage (full dilation)

Drug: Oxytocin

Delayed oxytocin

OTHER

This arm will receive oxytocin one hour after entering 2nd stage (full dilation)

Drug: Oxytocin

Interventions

OxytocinDRUG

Native oxytocin analog

Also known as: Pitocin
Delayed oxytocinImmediate oxytocin

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant Women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Singleton pregnancy
  • Maternal age ≥ 18 years' old
  • Oxytocin administration initiated or renewed during second stage of labor

You may not qualify if:

  • Maternal age \< 18 years' old
  • Multiple gestation pregnancy
  • Known fetal malformations
  • Uterine scar

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam medical health campus

Haifa, 31999, Israel

RECRUITING

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Central Study Contacts

Gal Bachar, MD

CONTACT

+97247771449g_bachar@rambam.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of OBGYN

Study Record Dates

First Submitted

September 10, 2023

First Posted

December 26, 2023

Study Start

October 1, 2023

Primary Completion

October 1, 2025

Study Completion (Estimated)

October 1, 2026

Last Updated

December 26, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

Locations

IL(1)