NCT06187948

Brief Summary

A randomized control trial to investigate whether an informative video before planned external cephalic version reduces maternal anxiety and improves chances of success.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Dec 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress60%
Dec 2023Dec 2027

First Submitted

Initial submission to the registry

May 2, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

December 26, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 3, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 3, 2024

Status Verified

April 1, 2023

Enrollment Period

2.9 years

First QC Date

May 2, 2023

Last Update Submit

December 17, 2023

Conditions

Breech Presentation

Keywords

breech presentationexternal cephalic versionmaternal anxietyinformative video

Outcome Measures

Primary Outcomes (1)

  • higher success rates.

    Comparing the percentage of successful External Cephalic Version (ECV) procedures between patients who watched an informative video about the procedure and those who did not receive this intervention.

    4 years

Secondary Outcomes (1)

  • impact of watching an informative video before external cephalic version on maternal anxiety levels

    4 years

Study Arms (2)

1. group that watches an informative video

EXPERIMENTAL

All participants in the intervention group watches an informative video on recruitment. This video describes in detail the expected external cephalic version process.

Other: Video

2. group that does not watch an informative video

NO INTERVENTION

this group do not watch an informative video before recruitment

Interventions

VideoOTHER

All participants in the intervention group watches an informative video on recruitment. This video describes in detail the expected external cephalic version process.

1. group that watches an informative video

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnancy
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women between ages 18-45
  • with a singleton gestation
  • at gestational week of 36 weeks 0 days until 38 weeks 0 days
  • who admitted labor word for external cephalic version .

You may not qualify if:

  • Women who had a past cesarean section
  • Women with oligohydramnios (Amniotic fluid index \< 5 cm)
  • Women who had a past external cephalic version
  • Women with a failed external cephalic version in current pregnancy
  • Women who take medication for depression/anxiety disorders
  • Women with a complicated pregnancy including fetal anomalies, polyhydramnios…

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

RECRUITING

MeSH Terms

Conditions

Breech Presentation

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Officials

  • Dorit Ravid, Dr

    Meir Hospital

    STUDY DIRECTOR

Central Study Contacts

Hila Shalev, Dr

CONTACT

972508807380hila6070@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2023

First Posted

January 3, 2024

Study Start

December 26, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

January 3, 2024

Record last verified: 2023-04

Locations

IL(1)