Laminaria Tents Versus Vaginal Prostaglandin in Cervical Ripening

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06151925

Enrollment

Registered

2023-11-30

Start date

2022-10-01

Completion date

2023-06-30

Last updated

2023-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Onset and Length Abnormalities

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

Interventions

DEVICELaminaria

mechanical method for induction of labor

DRUGVaginal prostaglandin

Vaginal prostaglandin for ripening

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

Other

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026