Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
ID06181396

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

Led by Rambam Health Care Campus · Updated on 2023-12-26

120

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research investigates the best timing to start oxytocin during the second stage of labor and how it relates to delivery outcomes and maternal or newborn complications. Cesarean delivery rates have risen globally, leading to more risks for mothers compared to vaginal delivery. The study aims to determine whether early oxytocin use at full dilation improves delivery type and reduces adverse effects for mother and baby. Participants will be randomly assigned to receive oxytocin either immediately upon entering the second stage of labor (full dilation) or one hour after entering this stage. Oxytocin, a common drug used to strengthen contractions and support labor progress, is being evaluated for how its timing affects delivery mode and outcomes. During the study, researchers will monitor delivery mode, length of the second labor stage, and complications such as fever, meconium staining, postpartum hemorrhage, fetal heart rate changes, newborn pH levels, Apgar scores, and neonatal intensive care admissions. The study includes all care from oxytocin administration through the immediate postpartum period, lasting up to five days for newborn monitoring.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Singleton pregnancy
  • Maternal age 18 years or older
  • Oxytocin administration started or renewed during the second stage of labor
Not Eligible

You will not qualify if you...

  • Maternal age under 18 years
  • Multiple gestation pregnancy
  • Known fetal malformations
  • Uterine scar

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Duration of the 2nd stage of labor

Participants receive oxytocin during the 2nd stage of labor either immediately upon full dilation or after a one-hour delay to assess the optimal timing of oxytocin initiation.

1 labor and delivery visit (in-person)

Follow-up

Duration - Up to 5 days postpartum

Participants and their newborns are monitored for maternal and neonatal outcomes including delivery mode, postpartum hemorrhage, and neonatal intensive care unit admission.

Approximately 1 to 2 post-delivery visits

Trial Site Locations

Total: 1 location

1

Rambam medical health campus

Haifa, Israel, 31999

Actively Recruiting

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Research Team

G

Gal Bachar, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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