The Effect of Primary Cesarean Section Prevention on Mate... | NCT03640702

Studies
The Effect of Primary Cesarean Section Prevention on Maternal and Neonatal Outcomes

NCT03640702

Sponsor

Rambam Health Care Campus

Status

Completed

Last Update Posted

Aug 21, 2018Actual

Enrollment

20,000Actual

Phase

Not provided

Conditions

Cesarean Section Complications

Interventions

Protocol change

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

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2017Actual

Primary Completion Date

Mar 1, 2018Actual

Completion Date

May 1, 2018Actual

First Submitted Date

Aug 14, 2018

First Submission Date that Met QC Criteria

Aug 17, 2018

First Posted Date

Aug 21, 2018Actual

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

Aug 17, 2018

Last Update Posted Date

Aug 21, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kamel Mattar MD, Principal Investigator, 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

The study aimed to examine the effect of prolonging the second stage of labor on the rate of Cesarean section (CS), maternal and neonatal outcomes.

The study compared 2 time periods. The first time period was between May 2011 until April 2014 when a prolonged second stage in nulliparous women was considered three hours with regional anesthesia or two hours if no such anesthesia was provided. Second stage arrest was defined in multiparous women after two hours with regional anesthesia or one hour without it. The second time period was between May 2014 until April 2017, allowed nulliparous and multiparous women to continue the second stage of labor an additional one hour before diagnosing second-stage arrest. Singleton deliveries at or beyond 37 weeks' gestation were initially considered for eligibility.

Detailed Description

The study aimed to examine the effect of prolonging the second stage of labor on the rate of Cesarean section (CS), maternal and neonatal outcomes.

The rate of CS, operative vaginal deliveries, 3rd and 4th degree lacerations, postpartum hemorrhage, arterial cord PH below 7 and admissions to the neonatal intensive care unit (NICU).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prolonged second stage of labor		Women with prolonged second stage of labor as specified before.	Other: Protocol change

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Protocol change	Other	To examine the effect of prolonging the second stage of labor on the rate of cesarean delivery, maternal and neonatal outcomes	Prolonged second stage of labor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The rate of primary CS.	The rate of primary CS in percentage of the total participants.	Between 2011 and 2017.

Secondary Outcomes

Measure	Description	Time Frame
The rate of operative vaginal delivery.	The rate of operative vaginal delivery in percentage of the total participants.	Between 2011 and 2017.
Post-partum hemorrhage.	Post-partum hemorrhage as estimated in liters.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. Singleton deliveries at or beyond 37 weeks' gestation.

Exclusion Criteria:

Non-vertex presentation.
Trial of labor after CS.
High risk pregnancy (multiple gestation, preeclampsia, diabetes mellitus, intrauterine growth restriction).
Known fetal anomalies and intrauterine fetal demise.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Female

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Pregnant women in labor

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kamel Mattar, MD	Principal Investigator	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rambam Health Care Campus		Haifa			Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided