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Laminaria Tents Versus Vaginal Prostaglandin in Cervical Ripening

NCT ID: NCT06151925

Last Updated: 2023-11-30

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

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-06-30

Brief Summary

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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

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A new method for induction of labor to be studied

Conditions

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Labor Onset and Length Abnormalities

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Laminaria tents group

Laminaria tent used to be inserted in cervix and left for 6-12 hours

Group Type ACTIVE_COMPARATOR

Laminaria

Intervention Type DEVICE

mechanical method for induction of labor

Vaginal prostaglandin

Intervention Type DRUG

Vaginal prostaglandin for ripening

vaginal prostaglandin group

Misoprostol 25 mcg inserted for one or multiple doses

Group Type PLACEBO_COMPARATOR

Laminaria

Intervention Type DEVICE

mechanical method for induction of labor

Vaginal prostaglandin

Intervention Type DRUG

Vaginal prostaglandin for ripening

Interventions

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Laminaria

mechanical method for induction of labor

Intervention Type DEVICE

Vaginal prostaglandin

Vaginal prostaglandin for ripening

Intervention Type DRUG

Other Intervention Names

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Vagiprost

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maya AbdelRazek, MD

Role: PRINCIPAL_INVESTIGATOR

Lecturer of obstetrics and gynecology - Ain Shams University

Locations

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Ain Shams University Faculty Of Medicine

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FMASU M D 63/2021

Identifier Type: -

Identifier Source: org_study_id