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

NCT ID: NCT06181396

Last Updated: 2023-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Delivery Complication Cesarean Delivery Affecting Fetus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immediate oxytocin

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

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

Native oxytocin analog

Delayed oxytocin

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

Group Type OTHER

Oxytocin

Intervention Type DRUG

Native oxytocin analog

Interventions

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Oxytocin

Native oxytocin analog

Intervention Type DRUG

Other Intervention Names

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Pitocin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Gal Bachar MD

Doctor of OBGYN

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rambam medical health campus

Haifa, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Gal Bachar, MD

Role: CONTACT

Phone: +97247771449

Email: [email protected]

Facility Contacts

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Gal Bachar, MD

Role: primary

Other Identifiers

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0061-22-RMB

Identifier Type: -

Identifier Source: org_study_id