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Completed

NCT Number: NCT06151925

Laminaria Tents Versus Vaginal Prostaglandin in Cervical Ripening

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.

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Key information

Conditions

Labor Onset and Length Abnormalities

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University Faculty Of Medicine

Cairo, Egypt

About this study

A new method for induction of labor to be studied

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

laminaria

Device

mechanical method for induction of labor

Vaginal prostaglandin

Drug

Vaginal prostaglandin for ripening

Other names: Vagiprost

Primary outcomes

  1. o Bishop Score and cervical dilatation

    Time frame: 2 YEARS

    Tool to assess cervical status

Secondary outcomes

  1. o Induction time to active phase of labor.

    Time frame: 2 YEARS

    Time between start and 5cm dilatation

  2. o Induction time to delivery time.

    Time frame: 2 YEARS

    Time between start to delivery

Other outcomes

  1. o Cesarean frequency rate

    Time frame: 2 YEARS

    Number of needed cs

  2. o Intrapartum complications

    Time frame: 2 YEARS

    Any complicated case

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 30, 2023
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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