An Informative Video Before Planned External Cephalic Version

NCT ID: NCT06187948

Last Updated: 2024-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-26

Study Completion Date

2027-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Women with a breech presentation scheduled to undergo an external cephalic version that meet the criteria are recruited in the Emergency Room by offering every woman that is scheduled to undergo an external cephalic version to participate. Women who agree to participate are asked to sign an inform consent, and are randomized to intervention group and control group. In the Emergency Room sonographic data is collected including amniotic fluid index, engaged presenting part, sonographic and clinical estimation of fetal weight, place of the placenta and various angles between the fetus and the bladder (These data are collected for the study). All participants in the intervention group watches an informative video on recruitment. This video describes in detail the expected external cephalic version process.

Before the external cephalic version and an hour after a successful or an unsuccessful external cephalic version the situation-specific anxiety is measured using the State-Trait Anxiety Inventory score (Attached).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breech Presentation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1. group that watches an informative video

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

Group Type EXPERIMENTAL

Video

Intervention Type OTHER

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

2. group that does not watch an informative video

this group do not watch an informative video before recruitment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Video

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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 .

Exclusion Criteria

* 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…
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dorit Ravid, Dr

Role: STUDY_DIRECTOR

Meir Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Meir Medical Center

Kfar Saba, , Israel

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hila Shalev, Dr

Role: CONTACT

972508807380

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hila Shalev, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0214-22

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Periviable Birth Plan
NCT03061864 UNKNOWN NA
Induction ATAD Catheter and Lower Segment Thickness
NCT06187779 ACTIVE_NOT_RECRUITING NA
Induction of Labor in Oligohydramnios
NCT00815542 UNKNOWN PHASE3