Laminaria Tents Versus Vaginal Prostaglandin in Cervical... | NCT06151925

Studies
Laminaria Tents Versus Vaginal Prostaglandin in Cervical Ripening

NCT06151925

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Nov 30, 2023Actual

Enrollment

90Actual

Phase

Not Applicable

Conditions

Labor Onset and Length Abnormalities

Interventions

Laminaria
Vaginal prostaglandin

Countries

Egypt

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

May 2021

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

Oct 1, 2022Actual

Primary Completion Date

Mar 1, 2023Actual

Completion Date

Jun 30, 2023Actual

First Submitted Date

May 25, 2022

First Submission Date that Met QC Criteria

Nov 21, 2023

First Posted Date

Nov 30, 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

Nov 21, 2023

Last Update Posted Date

Nov 30, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Mechanical methods used for induction of labor received a great attention nowadays due to the serious side effects of the pharmacological methods. Hygroscopic dilators are considered important subtype of these mechanical methods. One of them is Laminaria which is a synthetic type of sea algae that induces cervical dilation by absorbing water from the cervix and gradually increasing in thickness. The current study will compare the effectiveness and safety of laminiria and vaginal prostaglandins in induction of labor in women with unfavorable cervix.

Detailed Description

A new method for induction of labor to be studied

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

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Laminaria tents group	Active Comparator	Laminaria tent used to be inserted in cervix and left for 6-12 hours	Device: Laminaria Drug: Vaginal prostaglandin
vaginal prostaglandin group	Placebo Comparator	Misoprostol 25 mcg inserted for one or multiple doses	Device: Laminaria Drug: Vaginal prostaglandin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laminaria	Device	mechanical method for induction of labor	Laminaria tents group vaginal prostaglandin group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
o Bishop Score and cervical dilatation	Tool to assess cervical status	2 YEARS

Secondary Outcomes

Measure	Description	Time Frame
o Induction time to active phase of labor.	Time between start and 5cm dilatation	2 YEARS
o Induction time to delivery time.	Time between start to delivery

Other Outcomes

Measure	Description	Time Frame
o Cesarean frequency rate	Number of needed cs	2 YEARS
o Intrapartum complications	Any complicated case	2 YEARS

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant women with:
- Age 18-45 years.
- Live fetus with cephalic presentation.
- Normal non-stress test with reassuring features (baseline heart rate 110-160 beats/min, baseline variability 5-25 beats/minute, and no decelerations) (National Institute for Health and Clinical Excellence 2017).
- Gestational age of 37 weeks or more (Middleton et al. 2020).
- Fetal weight less than 4 kilograms.
- Bishop score less than 6 (Navve et al. 2017).
- No labor pains.
- No contraindications for vaginal delivery

Exclusion Criteria:

o Presence of fetal distress.
- Presence of thick meconium-stained amniotic fluid
- Presence of fever, chorioamnionitis, or vaginal bleeding before intervention.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

pregnant women

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maya AbdelRazek, MD	Lecturer of obstetrics and gynecology - Ain Shams University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams University Faculty Of Medicine		Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

It will be available once approved

Types

Study Protocol

Time Frame

Within one month from now

Access Criteria

Open access

URL

Not provided