Time of Oxytocin Initiation at 2nd Stage of Labor and Adv... | NCT06181396

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

NCT06181396

Sponsor

Rambam Health Care Campus

Status

Recruiting

Last Update Posted

Dec 26, 2023Actual

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Delivery Complication
Cesarean Delivery Affecting Fetus

Interventions

Oxytocin

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2023Actual

Primary Completion Date

Oct 2025Estimated

Completion Date

Oct 2026Estimated

First Submitted Date

Sep 10, 2023

First Submission Date that Met QC Criteria

Dec 22, 2023

First Posted Date

Dec 26, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2023

Last Update Posted Date

Dec 26, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gal Bachar MD, Doctor of OBGYN, Rambam Health Care CampusPrincipal Investigator

Lead Sponsor

Rambam Health Care CampusOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Oxytocin	Drug	Native oxytocin analog	Delayed oxytocin Immediate oxytocin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mode of delivery	Vaginal or instrumental or cesarean	Delivery

Secondary Outcomes

Measure	Description	Time Frame
2nd stage duration	Minutes	Delivery
intrapartum fever	Rate of chorioamnionitis	Delivery or 48 hours postpartum

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Pregnant Women

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gal Bachar, MD	Contact	+97247771449		g_bachar@rambam.health.gov.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rambam medical health campus	Recruiting	Haifa		31999	Israel

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010121	Oxytocin

Ancestor Terms

ID	Term
D010909	Pituitary Hormones, Posterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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.