Laminaria Tents Versus Vaginal Prostaglandin in Cervical Ripening

Study Overview
=================
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

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

Conditions
-----------------
Labor Onset and Length Abnormalities

Intervention / Treatment
-----------------
* Device: Laminaria
* Drug: Vaginal prostaglandin


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laminaria tents group<br>Laminaria tent used to be inserted in cervix and left for 6-12 hours | Device: Laminaria<br>* mechanical method for induction of labor<br>Drug: Vaginal prostaglandin<br>* Vaginal prostaglandin for ripening<br>* Other names: Vagiprost;|
| Placebo Comparator: vaginal prostaglandin group<br>Misoprostol 25 mcg inserted for one or multiple doses | Device: Laminaria<br>* mechanical method for induction of labor<br>Drug: Vaginal prostaglandin<br>* Vaginal prostaglandin for ripening<br>* Other names: Vagiprost;|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | 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 | 2 YEARS |