Early Versus Late Amniotomy During Labor Induction in Wom... | NCT04731896

Studies
Early Versus Late Amniotomy During Labor Induction in Women With Bishop's Score of ≥ 6

NCT04731896

Sponsor

University Tunis El Manar

Status

Completed

Last Update Posted

Sep 28, 2022Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Labor, Induced
Amniotomy

Interventions

Amniotomy

Countries

Tunisia

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

Sep 2022

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

Feb 8, 2021Actual

Primary Completion Date

Sep 30, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

Jan 26, 2021

First Submission Date that Met QC Criteria

Jan 26, 2021

First Posted Date

Feb 1, 2021Actual

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

Sep 26, 2022

Last Update Posted Date

Sep 28, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Labor induction is the stimulation of uterine contractions during pregnancy, before labor begins on its own to achieve a vaginal birth.

A health care provider might recommend labor induction for various reasons: primarily when there's concern for a mother's health or a baby's health.

Combined with oxytocin infusion, amniotomy is commonly used in the induction of labor. However the perfect timing of amniotomy is still unknown.

The aim of this study is to determine whether the early amniotomy followed by oxytocin, or initiating induction of labor with oxytocin followed by late amniotomy, is effective to reach active phase of labor.

Detailed Description

Not provided

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

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Late Amniotomy	No Intervention	Initiating induction of labor with oxytocin infusion followed by amniotomy 4-6 hours later
Early Amniotomy	Active Comparator	Early amniotomy initiating induction of labor followed by oxytocin infusion 30 minutes later	Procedure: Amniotomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Amniotomy	Procedure	artificial rupture of the amniotic sac	Early Amniotomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to active phase of labor	Total time from initiation oxytocin infusion to reaching 5 cm cervical dilation	At delivery

Secondary Outcomes

Measure	Description	Time Frame
Cesarean delivery rate	Rate of cesarean section	At delivery
Time to vaginal delivery	Total time from initiation of labor induction to vaginal delivery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years old
Full term (36 weeks and 3 days of gestation reached)
Singletion gestation in cephalic presentation
Bishop score of ≥ 6

Exclusion Criteria:

Prior uterine surgery, previous cesarean section
Ruptured membranes
Spontaneous labor
Multifetal pregnancy
Dystocic presentation
Fetal head not fixed at pelvic brim
Macrosomia
Hydramnios
Severe fetal growth restriction
Major fetal anomaly
Women with HIV, hepatitis C, hepatitis B
Women with medical conditions contraindication to a vaginal delivery
Women with COVID-19 infection

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

48 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University hospital Mongi Slim la Marsa		Tunis	La Marsa	2046	Tunisia

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

5 years from 01/01/2022

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000074885	Amniotomy

Ancestor Terms

ID	Term
D007751	Labor, Induced
D036861	Delivery, Obstetric
D013513	Obstetric Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided