Laminaria Tents Versus Vaginal Prostaglandin in Cervical Ripening

Not Applicable

Completed

• Conditions: Labor Onset and Length Abnormalities
• Interventions: Device: Laminaria; Drug: Vaginal prostaglandin

• Registration Number: NCT06151925
• Lead Sponsor: Ain Shams University

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

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2022-05-25
• Study Start: 2022-10-01
• Primary Completion: 2023-03-01
• Study Completion: 2023-06-30
• Study First Submitted QC: 2023-11-21
• Last Update Submitted: 2023-11-21
• Study First Posted: 2023-11-30
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laminaria tents group	Laminaria	Laminaria tent used to be inserted in cervix and left for 6-12 hours
Laminaria tents group	Vaginal prostaglandin	Laminaria tent used to be inserted in cervix and left for 6-12 hours
vaginal prostaglandin group	Laminaria	Misoprostol 25 mcg inserted for one or multiple doses
vaginal prostaglandin group	Vaginal prostaglandin	Misoprostol 25 mcg inserted for one or multiple doses

Primary Outcome Measures

Name	Time	Method
o Bishop Score and cervical dilatation	2 YEARS	Tool to assess cervical status

Secondary Outcome Measures

Name	Time	Method
o Induction time to active phase of labor.	2 YEARS	Time between start and 5cm dilatation
o Induction time to delivery time.	2 YEARS	Time between start to delivery

Trial Locations

Locations (1)

Ain Shams University Faculty Of Medicine; 🇪🇬 Cairo, Egypt