Laminaria Tents Versus Vaginal Prostaglandin in Cervical Ripening

N/ACompletedNCT06151925

Ain Shams University90 enrolled

Overview

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.

A new method for induction of labor to be studied

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Labor Onset and Length Abnormalities

Interventions

LaminariaDEVICE

mechanical method for induction of labor

Vaginal prostaglandinDRUG

Vaginal prostaglandin for ripening

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Ain Shams University Faculty Of Medicine

Cairo, Egypt

Outcomes

Primary Outcomes

o Bishop Score and cervical dilatation

Tool to assess cervical status

Time frame: 2 YEARS

Secondary Outcomes

o Induction time to active phase of labor.

Time between start and 5cm dilatation

Time frame: 2 YEARS

o Induction time to delivery time.

Time between start to delivery

Time frame: 2 YEARS

Data from ClinicalTrials.gov

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