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

What Was Tested

The trial (not phased) is built around Oxytocin.

It had two arms (groups): Immediate oxytocin (experimental) and Delayed oxytocin (other).

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

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

The registry classes the interventions as drug.

More on the Plan

Cesarean delivery (CD) is one of the most common surgeries performed worldwide.

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.

Despite its extensive use, there are several protocols which varies between different countries and obstetric wards.

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 Took Part

The registry lists 120 planned participants were the target.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Maternal age ≥ 18 years' old. Oxytocin administration initiated or renewed during second stage of labor.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: maternal age \< 18 years' old; multiple gestation pregnancy; known fetal malformations.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

The Oxytocin group and the comparison group ran side by side rather than switching.

Everyone knew when Oxytocin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2023-10-01 with completion listed for 2025-10.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Mode of delivery (time frame: Delivery).

It also tracked 8 secondary outcomes, for example 2nd stage duration, intrapartum fever, Meconium stain, Postpartum hemorrhage, FHR decelerations and Neonatal pH.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 120 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.