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

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.

Study Overview

• Status: Completed
• Conditions: Labor Onset and Length Abnormalities
• Intervention / Treatment: Device: Laminaria; Drug: Vaginal prostaglandin

Detailed Description

A new method for induction of labor to be studied

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University Faculty Of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Maya AbdelRazek, MD, Lecturer of obstetrics and gynecology - Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: November 21, 2023
• First Posted (Actual): November 30, 2023

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: FMASU M D 63/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: It will be available once approved
• IPD Sharing Time Frame: Within one month from now
• IPD Sharing Access Criteria: Open access
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes