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Laminaria Tents Versus Vaginal Prostaglandin in Cervical Ripening

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT06151925
Collaborator
(none)
90
Enrollment
1
Location
2
Arms
8.9
Actual Duration (Months)
10.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Laminaria
  • Drug: Vaginal prostaglandin
 N/A

Detailed Description

A new method for induction of labor to be studied

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Laminaria Tents Versus Vaginal Prostaglandin in Cervical Ripening in Term Induction of Labor With Unfavorable Cervix:A Randomized Controlled Trial
Actual Study Start Date :
Oct 1, 2022
Actual Primary Completion Date :
Mar 1, 2023
Actual Study Completion Date :
Jun 30, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. o Bishop Score and cervical dilatation [2 YEARS]

      Tool to assess cervical status

    Secondary Outcome Measures

    1. o Induction time to active phase of labor. [2 YEARS]

      Time between start and 5cm dilatation

    2. o Induction time to delivery time. [2 YEARS]

      Time between start to delivery

    Other Outcome Measures

    1. o Cesarean frequency rate [2 YEARS]

      Number of needed cs

    2. o Intrapartum complications [2 YEARS]

      Any complicated case

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ain Shams University Faculty Of Medicine Cairo Egypt

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT06151925
    Other Study ID Numbers:
    • FMASU M D 63/2021
    First Posted:
    Nov 30, 2023
    Last Update Posted:
    Nov 30, 2023
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Additional relevant MeSH terms:
    Congenital Abnormalities

    Study Results

    No Results Posted as of Nov 30, 2023