Laminaria Tents Versus Vaginal Prostaglandin in Cervical Ripening

NCT06151925 | Completed DMC FDA Device

• 1 other identifier: FMASU M D 63/2021
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Onset and Length Abnormalities

Outcome Measures

Primary Outcomes (1)

• o Bishop Score and cervical dilatation

  Tool to assess cervical status

  2 YEARS

Secondary Outcomes (2)

• o Induction time to active phase of labor.

  2 YEARS

• o Induction time to delivery time.

  2 YEARS

Other Outcomes (2)

• o Cesarean frequency rate

  2 YEARS

• o Intrapartum complications

  2 YEARS

Study Arms (2)

Laminaria tents group

ACTIVE COMPARATOR

Laminaria tent used to be inserted in cervix and left for 6-12 hours

Device: Laminaria; Drug: Vaginal prostaglandin

vaginal prostaglandin group

PLACEBO COMPARATOR

Misoprostol 25 mcg inserted for one or multiple doses

Device: Laminaria; Drug: Vaginal prostaglandin

Interventions

Laminaria DEVICE

mechanical method for induction of labor

Laminaria tents group; vaginal prostaglandin group

Vaginal prostaglandin DRUG

Vaginal prostaglandin for ripening

Also known as: Vagiprost

Laminaria tents group; vaginal prostaglandin group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• o Presence of fetal distress.
• Presence of thick meconium-stained amniotic fluid
• Presence of fever, chorioamnionitis, or vaginal bleeding before intervention.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Faculty Of Medicine

Cairo, Egypt

Location

Study Officials

• Maya AbdelRazek, MD

  Lecturer of obstetrics and gynecology - Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: November 30, 2023
• Study Start: October 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: June 30, 2023
• Last Updated: November 30, 2023

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within one month from now
• Access Criteria: Open access

Locations

EG (1)