Laminaria Tents Versus Vaginal Prostaglandin in Cervical Ripening

Labor Onset and Length Abnormalities Clinical Trial

Official title:

Laminaria Tents Versus Vaginal Prostaglandin in Cervical Ripening in Term Induction of Labor With Unfavorable Cervix:A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06151925
• Other study ID #: FMASU M D 63/2021
• Status: Completed
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A new method for induction of labor to be studied

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 30, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Labor Onset and Length Abnormalities

Intervention

Device:
• Laminaria
mechanical method for induction of labor

Drug:
• Vaginal prostaglandin
Vaginal prostaglandin for ripening

Locations

Country	Name	City	State
Egypt	Ain Shams University Faculty Of Medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	o Cesarean frequency rate	Number of needed cs	2 YEARS
Other	o Intrapartum complications	Any complicated case	2 YEARS
Primary	o Bishop Score and cervical dilatation	Tool to assess cervical status	2 YEARS
Secondary	o Induction time to active phase of labor.	Time between start and 5cm dilatation	2 YEARS
Secondary	o Induction time to delivery time.	Time between start to delivery	2 YEARS